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Albumin CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba.com
Waste ManagementPlease refer to local legal requirements.
General Precautions1. Reagent, for professional
in-vitrodiagnostic use only.
2. The reagent cassettes are disposable and should be disposed
of in
accordance with the local legal requirements.
3. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below
have been obtained on the ABX
Pentra 400 analyser.
Number of tests: 327 tests.
On board Reagent Stability:
Once opened, the reagent cassette placed in the refrigerated
ABX
Pentra 400 compartment is stable for 83 days.
Sample volume: 2 l/test
Detection limit:
The detection limit is determined according to the Valtec
protocol (6)
and equals 2.9 mol/l.
Accuracy and Precision:
Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls
aretested 20 times according to the recommendations found in the
Valtec
protocol (6).
Reproducibility (run-to-run precision)
2 specimens of low and high levels and 2 controls are tested
in
duplicate for 20 days (2 series per day) according to
therecommendations found in the NCCLS, EP5-A protocol (7).
Linearity and Measuring Range:
The reagent linearity is determined according to the
recommendations
found in the NCCLS, EP6-P protocol (8).
Low linearity: 2.9 mol/l
High linearity: 909 mol/l, with automatic post-dilution: 1818
mol/l.
Correlation:
59 patient samples are correlated with a commercial reagent
taken as
reference according to the recommendations found in the NCCLS,
EP9-
A2 protocol (9).
The equation for the allometric line obtained is:
Y = 0.95 x + 22 with a correlation coefficient r = 0.992.
Interferences:
Conversion factora:
mol/l x 0.066 = g/l
mol/l x 0.0066 = g/dl
Calibration stabilityb:
The reagent is calibrated on Day 0. The calibration stability is
checked
by testing 2 control specimens.
The calibration stability is at least 14 days.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Application release: 4.xx
WarningIt is the user's responsibility to verify that this
document is applicable
to the reagent used.
Reference1. Doumas B. et al., Watson. W, Ard and Biggs H.G.
Albumin
standards and the measurement of serum albmin with
bromocresol
green, Clin. Chim. Acta, 31, (1971), 87.
2. Doumas B. T. and Biggs H.G., Determination of serum
albumin
Standard Methods of Clinical Chemistry, Acad. Press N.Y., 7,
(1972), 175.
3. Drupt F., Dosage de lalbumine srique par le vert de
bromocrsol
Pharm. Biol., 9, (1974), 777.4. Metais P. Biochimie Clinique.
Tome 3: Biochimie fonctionnelle:
Srum Albumine. Paris: Simep; 1988:107.
5. Doumas BT., PETERS T Jr. - Serum and urine albumin albumin:
a
progress report on their measurement and clinical
significance.
Clin. Chim. Acta., 258(1), (1997), 3-20.
6. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de
validation
de techniques (document B), Ann. Biol. Clin., 1986, 44,
686-745.
7. Evaluation of Precision Performance of Clinical Chemistry
Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
Mean value mol/l CV %
Normal control 514 0.6
Pathological control 506 0.8
Specimen 1 349 0.4
Specimen 2 629 0.5
Specimen 3 848 0.8
Mean value mol/l CV %
Normal control 515 1.26
Pathological control 502 0.95
Specimen 1 357 1.66
Specimen 2 643 1.85
Haemoglobin: No significant influence is observed up to 232
mol/l
Triglycerides: No significant influence is observed up to 7
mmol/l
Total Bilirubin: No significant influence is observed up to 616
mol/l
Direct Bilirubin: No significant influence is observed up to 616
mol/l
a. Modification from index I to J: correction of conversion
factor.b. Modification from index I to J: modification of
calibration stability.
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3/111
Albumin CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba.com
8. Evaluation of the Linearity of Quantitative Analytical
Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
9. Method Comparison and Bias Estimation Using Patient
Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22,
No.
19, 2002.
10. Johnson, A.M., Rohlfs, E.M., Silverman, L.M., Proteins,
Tietz
Fundamentals of Clinical Chemistry, 5thEd., Burtis, C.A.,
Ashwood,
E.R., (W.B. Saunders eds. Philadelphia USA), (2001), 325.
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8/10/2019 Substrates P400 En
4/111
Albumin CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba.com
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Bilirubin, Direct CP
ABX Pentra
2007/08/27A93A00122H EN
A11A01635
24 ml
7 ml
HORIBA ABX
BP 729034184 Montpellier- cedex 4 - France
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
ABX Pentra Bilirubin, Direct CPRef.: A11A01635Volume R1: 24
mlVolume R2: 7 ml
Diagnostic reagent for quantitative in-vitrodetermination of
direct Bilirubin in serumand plasma.
Clinical Interest (1,2)Bilirubin is a breakdown product of
hemoglobin. Free, unconjugated
bilirubin is extremely apolar and nearly insoluble in water,
thus
forming a complex with albumin for the transport in the blood
from
the spleen to the liver. In the liver, bilirubin is conjugated
with
glucoronic acid and the resulting water soluble bilirubin
glucoronicacid is excreted via the bile ducts.
Hyperbilirubinemia can be caused by increased bilirubin
production due
to hemolysis (pre-hepatic jaundice), by parenchymal damages of
the
liver (intra-hepatic jaundice) or by occlusion of bile ducts
(post-hepatic
jaundice). A chronic congenital (predominantly unconjugated)
hyperbilirubinemia called Gilberts syndrome is quite frequent in
the
population. High levels of total bilirubin are observed in
60-70% of
neonates due to an increased postpartal breakdown of
erythrocytes and
because of delayed function of enzymes for bilirubin
degradation.
Common bilirubin methods detect either total bilirubin or
direct
bilirubin. Determinations of direct bilirubin measure mainly
conjugated,
water soluble bilirubin. Unconjugated bilirubin can therefore
be
estimated as the difference between total bilirubin and direct
bilirubin.
MethodPhotometric test using 2,4-dichloroaniline (DCA).
Direct bilirubin in presence of diazotized 2,4-dichloroaniline
forms a
red colored azocompound in acidic solution.
ReagentsABX Pentra Bilirubin, Direct CPis ready-to-use.
ABX Pentra Bilirubin, Direct CP should be used according to
thisreagent notice. HORIBA ABX cannot guarantee its performance if
used
otherwise.
Handlinga
Remove both caps of the cassette. If present, remove foam by
using a
plastic pipette.
Position the respective protective cap, ref. GBM0969 on R1 and
Ref.
GBM0970 on R2 and place in the refrigerated ABX Pentra 400
reagent
compartment.
Reagent 1: EDTA-Na2 0.1 mmol/l
NaCl 9 g/l
Sulfamic acid 100 mmol/l
Reagent 2: 2,4-Dichlorophenyl-diazonium salt 0.5 mmol/l
HCl 700 mmol/l
EDTA-Na2 0.13 mmol/l
a. Modification from index G to H: new handling.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)10 x 3 ml
(lyophilisate)
Control
For internal quality control, use:ABX Pentra N Control, Ref.
A11A01653 (not included)10 x 5 ml (lyophilisate)
ABX Pentra P Control, Ref. A11A01654 (not included)10 x 5 ml
(lyophilisate)
Each control should be assayed daily and/or after each
calibration.
The frequency of controls and the confidence intervals
should
correspond to laboratory guidelines and country-specific
directives.
The results must be within the range of the defined confidence
limits.
Each laboratory should establish a procedure to follow if the
results
exceed these confidence limits.
Materials required but not provided
Automated clinical chemistry analyser NaCl solution: 9 g/l
Standard laboratory equipment.
Specimen Serum.
Heparin Plasma.
It is very important to store the sample protected from
light.
Freeze only once.
Stability: 2 days at 15 - 25 C
7 days at 2 - 8 C
3 months at - 20 C in case of immediate freezing.
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6/111
Bilirubin, Direct CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
Reference range (1)Adults and children:0 - 0.2 mg/dl (0 - 3.4
mol/l).
Storage and StabilityReagents, in unopened cassettes, are stable
up to the expiry date on
the label if stored at 2 - 8 C protected from light and
contamination
is avoided.
Stability after opening : refer to the paragraph Performance on
ABX
Pentra 400.
Do not freeze the reagents.
Assay Procedure
Test instructions for other automated systems than ABX Pentra
400 areavailable on request.
Waste ManagementPlease refer to local legal requirements.
General Precautions1. This reagent is for professional
in-vitrodiagnostic use only.
2. Take the necessary precautions for the use of laboratory
reagents.
3. The reagent cassettes are disposable and should be disposed
of in
accordance with the local legal requirements.
4. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below
have been obtained on the ABX
Pentra 400 analyser.
Number of tests: 100 tests
On board Reagent Stabilitya:Once opened, the reagent cassette
placed in the refrigerated ABX
Pentra 400 compartment is stable for 30 days.
Sample volume: 25 l/test
Detection limit:The detection limit is determined according to
the Valtec protocol (4)
and equals 0.69 mol/l.
Accuracy and Precision: Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls
are
tested 20 times according to the recommendations found in the
Valtec
protocol (4).
Reproducibility (run-to-run precision)
2 specimens of low and high levels and 2 controls are tested
in
duplicate for 20 days (2 series per day) according to the
recommendations found in the NCCLS, EP5-A protocol (5).
Linearity and Measuring Range:The reagent linearity is
determined according to the recommendations
found in the NCCLS, EP6-P protocol (6).Low linearity: 0.69
mol/l
High linearity: 116 mol/l, with automatic post-dilution: 580
mol/l.
Correlation:100 patient samples are correlated with a commercial
reagent taken as
reference according to the recommendations found in the NCCLS,
EP9-
A2 protocol (7).
The equation for the allometric line obtained is:
Y = 0.92 x + 0.58 with a correlation coefficient r2= 0.9899.
Interferences:
Conversion factor:mol/l x 0.584 = mg/l
mol/l x 0.0584 = mg/dl
Calibration stabilityb:The reagent is calibrated on Day 0. The
calibration stability is checked
by testing 2 control specimens.
The calibration stability is at least 10 days.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Application release
c
: 3.xx
WarningIt is the users responsibility to verify that this
document is applicable
to the reagent used.
Reference1. Thomas L. ed. Clinical Laboratory Diagnostics.
1sted. Frankfurt:
TH-Books Verlagsgesellschaft, 1998; 192-202.
2. Tolman K.G., Rej R. Liver function. In: Burtis C.A., Ashwood
E.R.,
editors. Tietz Textbook of Clinical Chemistry. 3rded.
Philadelphia:
W.B Saunders Company; 1999. p. 1125-1177.
a. Modification from index G to H: new on board reagent
stability.
Mean value mol/l CV %
Normal control 15.3 0.67
Pathological control 31.6 0.44
Specimen 1 4.0 3.23
Specimen 2 25.9 0.59
Specimen 3 134.6 2.69
Mean value mol/l CV %
Normal control 16.0 4.26
Pathological control 34.6 4.22
Specimen 1 11.7 3.27
Specimen 2 65.4 2.98
Haemoglobin: Do not use haemolysed samples.
Triglycerides: No significant influence is observed up to 7
mmol/l.
b. Modification from index G to H: modification of calibration
stability.c. Modification from index F to G: suppression of minor
index.
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8/10/2019 Substrates P400 En
7/111
Bilirubin, Direct CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
3. Rand R.N., di Pasqua A. A new diazo method for the
determination
of bilirubin. Clin. Chem. 1962; 6:570-8.4. Vassault A.,
Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44,
686-745.5. Evaluation of Precision Performance of Clinical
Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
6. Evaluation of the Linearity of Quantitative Analytical
Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
7. Method Comparison and Bias Estimation Using Patient
Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22,
No.
19, 2002.
-
8/10/2019 Substrates P400 En
8/111
Bilirubin, Direct CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
-
8/10/2019 Substrates P400 En
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Bilirubin, Total CP
ABX Pentra
2009/10/21A93A00112O EN
A11A01639
44 ml
14 ml
HORIBA ABX SAS
BP 729034184 Montpellier- cedex 4 - France
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba.com
ABX Pentra Bilirubin, Total CPRef.: A11A01639Volume R1: 44
mlVolume R2: 14 ml
Intended Use
Diagnostic reagent for quantitative in-vitrodetermination of
total Bilirubin in serum and plasmaof adults and neonates.
Clinical Interest (1,2)Bilirubin is a breakdown product of
hemoglobin. Free, unconjugated
bilirubin is extremely apolar and nearly insoluble in water,
thus
forming a complex with albumin for the transport in the blood
from
the spleen to the liver. In the liver, bilirubin is conjugated
with
glucoronic acid and the resulting water soluble bilirubin
glucoronidesare excreted via the bile ducts.
Hyperbilirubinemia can be caused by increased bilirubin
production
due to hemolysis (pre-hepatic jaundice), by parenchymal damages
of
the liver (intra-hepatic jaundice) or by occlusion of bile ducts
(post-
hepatic jaundice). A chronic congenital (predominantly
unconjugated)
hyperbilirubinemia called Gilberts syndrome is quite frequent in
the
population. High levels of total bilirubin are observed in
60-70% of
neonates due to an increased postpartal breakdown of
erythrocytes
and because of delayed function of enzymes for bilirubin
degradation.
Common bilirubin methods detect either total bilirubin or
direct
bilirubin. Determinations of direct bilirubin measure mainly
conjugated, water soluble bilirubin. Unconjugated bilirubin
can
therefore be estimated as the difference between total bilirubin
and
direct bilirubin.
Method (3)Photometric test using 2,4-dichloroaniline (DCA).
Direct bilirubin in presence of diazotized 2,4-dichloroaniline
forms a
red colored azocompound in acidic solution. A specific mixture
of
detergents enables a safe determination of the total
bilirubin.
ReagentsABX Pentra Bilirubin, Total CPis ready-to-use.
ABX Pentra Bilirubin, Total CP should be used according to
thisreagent notice. The manufacturer cannot guarantee its
performance if
used otherwise.
HandlingRemove both caps of the cassette, place in the
refrigerated ABX Pentra
400 reagent compartment.
If present, remove foam by using a plastic pipette.
Reagent 1:Phosphate buffer 50 mmol/l
NaCl 9 g/l
Detergent, stabilizersReagent 2:2,4-Dichlorophenyl-diazonium
salt 5 mmol/l
HCl 130 mmol/l
Detergent
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)10 x 3 ml
(lyophilisate)
Control
For internal quality control, use:ABX Pentra N Control, Ref.
A11A01653 (not included)10 x 5 ml (lyophilisate)ABX Pentra P
Control, Ref. A11A01654 (not included)10 x 5 ml (lyophilisate)
Each control should be assayed daily and/or after each
calibration.
The frequency of controls and the confidence intervals
should
correspond to laboratory guidelines and country-specific
directives.
The results must be within the range of the defined confidence
limits.
Each laboratory should establish a procedure to follow if the
results
exceed these confidence limits.
Materials required but not provided Automated clinical chemistry
analyser: ABX PENTRA 400 Calibrator: ABX Pentra Multical, Ref.
A11A01652 Controls: ABX Pentra N Control, Ref. A11A01653, and
ABX Pentra P Control, Ref. A11A01654 NaCl solution 9 g/l
Standard laboratory equipment.
Specimen Serum.
Plasma in lithium heparin.
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10/111
Bilirubin, Total CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba.com
Stability (1,10):
1 day at 20-25C
7 days at 4-8C
6 months at -20C
It is very important to store the sample protected from
light!
In the case of intensive sun irradiation: decrease in total
bilirubin by
up to 30% after 1 hour.
Reference range (1)Each laboratory should establish its own
reference ranges. The values
given here are used as guidelines only.
Storage and StabilityReagents, in unopened cassettes, are stable
up to the expiry date on
the label if stored at 2 - 8 C and contamination is avoided.
Stability after opening : refer to the paragraph Performance on
ABX
Pentra 400.Do not freeze the reagents.
Assay ProcedureTest instructions for other automated systems
than ABX Pentra 400 are
available on request (not available in the USA).
Waste ManagementPlease refer to local legal requirements.
General Precautions1. This reagent is for professional
in-vitrodiagnostic use only.
2. Take the necessary precautions for the use of laboratory
reagents.
3. The reagent cassettes are disposable and should be disposed
of inaccordance with the local legal requirements.
4. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below
have been obtained on the ABX
Pentra 400 analyser.
Number of tests: 200 tests
On board Reagent Stability:Once opened, the reagent cassette
placed in the refrigerated ABX
Pentra 400 compartment is stable for 25 days.
Sample volume: 8 l/test
Limits:Limit of blank:
The limit of blank is determined according to CLSI (NCCLS),
EP17-A
protocol (8) and equals 1.09 mol/l.
Limit of detection:
The detection limit is determined according to CLSI (NCCLS),
EP17-A
protocol (8)and equals 1.49 mol/l.
Limit of quantitation:The limit of quantitation is determined
according to CLSI (NCCLS),
EP17-A protocol (8) and equals 2.4 mol/l.
Accuracy and Precision: Repeatability (within-run precision)
4 specimens of very low, low, medium and high concentration and
2
controls are tested 20 times according to the recommendations
found
in the Valtec protocol (4).
Reproducibility (total precision)
3 specimens of low, medium and high levels and 2 controls are
tested
in duplicate for 20 days (2 series per day) according to the
recommendations found in the CLSI (NCCLS), EP5-A protocol
(5).
Measuring Range:The assay confirmed a measuring range in serum
and plasma from 2.4
to 450.0 mol/l, providing an upper linearity of 450.0 mol/l,
with an
automatic post-dilution up to 1350 mol/l.
The reagent linearity is determined according to the
recommendations
found in the CLSI (NCCLS), EP6-A protocol (6)
Correlation (adult samples):101 patient samples (serum)are
correlated with a commercial reagent
taken as reference according to the recommendations found in
the
CLSI (NCCLS), EP9-A2 protocol (7). Values ranged from 5.6 to
441.8
mol/l.
mg/dl mol/l
Neonates:
24 hours: < 8.7 < 150
2nd day: 1.3 - 11.3 22 - 193
3rd day: 0.7 - 12.7 12 - 217
4th - 6th day: 0.1 - 12.6 2 - 216
Adults: 0.1 - 1.2 2 - 21
Mean value mol/l CV %
Control specimen 1 16.59 2.14
Control specimen 2 87.61 0.99
Specimen 1 10.34 3.09
Specimen 2 14.57 2.23Specimen 3 37.65 1.33
Specimen 4 142.82 0.83
Mean value mol/l CV %
Control specimen 1 17 4.04
Control specimen 2 94 1.70
Specimen 1 13.62 5.97
Specimen 2 48.96 2.78Specimen 3 156.13 2.20
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Bilirubin, Total CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba.com
The equation for the allometric line obtained using
Passing-Bablock
regression procedure (9)is:
Y = 1.03 x - 2.43 mol/l with a correlation coefficient r2=
0.9965.
Correlation (neonatal samples):112 patient samples (serum) are
correlated with a commercial reagent
taken as reference according to the recommendations found in
the
CLSI (NCCLS), EP9-A2 protocol (7). Values ranged from 3.17 to
434.14
mol/l.
The equation for the allometric line obtained using
Passing-Bablock
regression procedure (9) is:
Y = 0.95 X + 0.085 mol/l with a correlation coefficient r2=
0.993.
Interferences:
Other limitations are given by Young as a list of drugs and
preanalytical
variables known to affect this methodology (11,12).
Calibration stability:The reagent is calibrated on Day 0. The
calibration stability is checked
by testing 2 control specimens.
The calibration stability is at least 10 days.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Conversion factor:mol/l x 0.585 = mg/l
mol/l x 0.0585 = mg/dl
Software version: 4.4 - Application release: 7.xx
Software version: 5.0 - Application release: 8.xx
Warning
It is the users responsibility to verify that this document is
applicableto the reagent used.
Reference1. Thomas L. ed. Clinical Laboratory Diagnostics.
1sted. Frankfurt:
TH-Books Verlagsgesellschaft, 1998. p 192-202.
2. Tolman K.G., Rej R. Liver function. In: Burtis C.A., Ashwood
E.R.,
editors. Tietz Textbook of Clinical Chemistry. 3rded.
Philadelphia:
W.B Saunders Company; 1999. p. 1125-77.
3. Rand R.N., di Pasqua A. A new diazo method for the
determination
of bilirubin. Clin. Chem. 1962; 6:570-8.4. Vassault A.,
Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44,
686-745.5. Evaluation of Precision Performance of Clinical
Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
6. Evaluation of the Linearity of Quantitative Analytical
Methods,
Approved Guideline, CLSI (NCCLS) document EP6-A, Vol. 23,
No.
16, april 2003.
7. Method Comparison and Bias Estimation Using Patient
Samples,
Approved Guideline, 2nded., CLSI (NCCLS) document EP9-A2,
Vol.
22, No. 19, 2002.
8. Protocols for determination of limits of detection and limits
of
quantitation, Approved Guideline, CLSI (NCCLS) document
EP17-A,
Vol. 24, No. 34, 2004.
9. Passing H., Bablock W. A new biometrical procedure for
testing the
equality of measurements from two different analytical
methods.
J. Clin. Chem. Clin. Biochem. 1983; 21: 709-20.
10. Use of Anticoagulants in Diagnostics Laboratory
Investigations.
WHO Publication WHO/DIL/LAB/99.1 rev.2, 2002.
11. Young D.S., Effects of Drugs on Clinical Laboratory Tests,
4th
Edition, Washington, DC, AACC Press, 1995, 3: 143-163.
12. Young D.S., Effects of Preanalytical Variables on
Clinical
Laboratory Tests, 2ndEdition, Washington, DC, AACC Press,
1997,
3: 120-132.
Haemoglobin: No significant influence is observed up to 500
mg/dl
(290 mol/l).
Triglycerides: No significant influence is observed up to 612.5
mg/dl
(7 mmol/l).
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Calcium AZ III CP
ABX Pentra
2008/09/09A93A01221A EN
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
A11A01894
79 ml
HORIBA ABX
BP 729034184 Montpellier - cedex 4 - France
ABX Pentra Calcium AZ III CPRef.: A11A01894Volume R1: 79
mlVolume R2: 1 x 5 ml
Intended use
Diagnostic reagent for quantitative in-vitrodetermination of
Calcium in serum, plasma andurine.
Clinical Interest (1,2,3)Calcium plays an essential role in many
cell functions: intracellularly
in muscle contraction and glycogen metabolism, extracellularly,
in
bone mineralization, in blood coagulation and in transmission of
nerve
impulses. Calcium is present in plasma in three forms: free,
bound to
proteins or complexed with anions as phosphate, citrate
andbicarbonate. Under physiological conditions, calcium balance
is
determined by the relationship between calcium intake and
calcium
absorption and excretion. Urinary excretion is an important
determinant of calcium retention in the body.
Decreased total calcium levels can be associated with diseases
of the
bone apparatus (especially osteoporosis), kidney diseases
(especially
under dialysis), defective intestinal absorption and
hypoparathyroidism.
Increased total calcium can be measured in
hyperparathyroidism,
malignant diseases with metastases and sarcoidosis. Calcium
measurements also help in monitoring of calcium
supplementation
mainly in the prevention of osteoporosis.
Method (4,5,6,7)Many colourimetric methods for determining
calcium have been used
in the past. Connerty and Briggs described methods using
alizarin 3-
sulphonate (4)and cresolphthalein complexone (5)whilst Gindler
and
King have described a method using thymol blue (6).
There have been many subsequent modifications to these
methods.
The method used here is based on the metallochromogen Arsenazo
III.
Calcium ions (Ca2+) react with Arsenazo III
(2,2-[1,8-Dihydroxy-3,6-
disulphonaphthylene-2,7-bisazo]- bisbenzenearsonic acid) at pH
6.75
to form an intense purple coloured chromophore. The absorbance
of
the Ca-Arsenazo III complex is measured bichromaticcally at
660/700
nm. The resulting increase in absorbance of the reaction mixture
is
directly proportional to the calcium concentration in the
sample.
Arsenazo III has a high affinity (K = 1 x 10-7) for calcium ions
(7) andshows no interference from other cations normally present in
serum,
plasma or urine.
pH 6.75Ca+++ Arsenazo III Ca-Arsenazo III complex (purple)
ReagentsABX Pentra Calcium AZ III CPis ready-to-use.
ABX Pentra Calcium AZ III CP should be used according to
this
reagent notice. HORIBA ABX cannot guarantee its performance if
used
otherwise.
HandlingRemove the cap of the cassette. If present, remove foam
by using a
plastic pipette. Position the protective cap, ref. GBM0969 and
place
the cassette in the refrigerated ABX Pentra 400 reagent
compartment.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)
10 x 3 ml (lyophilisate)
ControlFor internal quality control, use:
ABX Pentra N Control, Ref. A11A01653 (not included)
10 x 5 ml (lyophilisate)
ABX Pentra P Control, Ref. A11A01654 (not included)
10 x 5 ml (lyophilisate)
ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)
1 x 10 ml + 1 x 10 ml
Reagent : Arsenazo III 0.2 mmol/l
Imidazole buffer 100 mmol/l
Sodium azide 0.05%
SurfactantStabilizers
pH 6.75 0.1
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Calcium AZ III CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
Accuracy and Precision:
Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls
are
tested 20 times according to the recommendations found in the
Valtec
protocol (11).
Reproducibility (total precision)
3 specimens of low, medium and high concentration and 2 controls
are
tested 20 times according to the recommendations found in the
CLSI
(NCCLS) EP05-A protocol (12).
Measuring Range:
The assay confirmed a measuring range from 0.1 mmol/l to 4.50
mmol/l, providing an upper linearity of 4.50 mmol/l, with an
automatic post-
dilution up to 13.50 mmol/l.
The reagent linearity is determined according to the
recommendations
found in the CLSI (NCCLS), EP6-A protocol (13).
Correlation:
134 patient samples (serum) are correlated with a commercial
reagent
taken as reference according to the recommendations found in
the
CLSI (NCCLS), EP9-A2 protocol (14). Values ranged from 0.16 to
4.40
mmol/l.
The equation for the allometric line obtained using
Passing-Bablock
regression procedure (15)is:
Y = 0.98 x - 0.02 with a correlation coefficient r2= 0.9958.
Interferences:
Other limitations are given by Young as a list of drugs and
preanalytical
variables known to affect this methodology (16,17).
Conversion factor:
mmol/l x 40.1 = mg/l
Calibration stability:
The reagent is calibrated on Day 0. The calibration stability is
checked
by testing 2 control specimens.
The calibration stability is 7 days.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Application release: 2.xx
Urine
Number of tests: 250 tests
On board Reagent Stability:
Once opened, the reagent cassette placed in the refrigerated
ABX
Pentra 400 compartment is stable for 60 days.
Sample volume: 6 l/test
Detection limit:The detection limit is determined according to
CLSI (NCCLS), EP17-A
protocol (10)and equals 0.08 mmol/l.
Limit of quantitation:
The limit of quantitation is determined according to CLSI
(NCCLS),
EP17-A protocol (10)and equals 0.25 mmol/l.
Accuracy and Precision:
Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls
are
tested 20 times according to the recommendations found in the
Valtec
protocol (11).
Mean value mmol/l CV %
Control specimen 1 2.30 0.46
Control specimen 2 2.89 0.51
Specimen 1 1.80 0.93
Specimen 2 2.42 0.70
Specimen 3 3.32 0.73
Mean value mmol/l CV %
Control specimen 1 2.33 2.53
Control specimen 2 2.94 2.29
Specimen 1 1.84 1.75
Specimen 2 2.48 2.30
Specimen 3 3.40 1.78
Haemoglobin: No significant influence is observed up to 290
mol/l
(500 mg/dl).
Triglycerides: No significant influence is observed up to 7
mmol/l
(612.5 mg/dl).
(as Intralipid, representative of lipemia)
Total Bilirubin: No significant influence is observed up to 400
mol/l
(23.4 mg/dl).
Direct Bilirubin:No significant influence is observed up to 450
mol/l
(26.3 mg/dl).
Mean value mmol/l CV %
Control specimen 1 1.73 1.14
Control specimen 2 2.55 0.71
Specimen 1 1.02 0.92
Specimen 2 2.49 0.74
Specimen 3 4.03 0.52
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Calcium AZ III CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
Reproducibility (total precision)
3 specimens of low, medium and high levels and 2 controls are
tested
in duplicate for 20 days (2 series per day) according to the
recommendations found in the CLSI (NCCLS), EP5-A protocol
(12).
Measuring Range:
The assay confirmed a measuring range from 0.25 mmol/l to
4.50mmol/l, with an automatic post-dilution up to 13.50 mmol/l.
The reagent linearity has been assessed up to 4.50 mmol/l,
in
accordance with CLSI (NCCLS), EP6-A protocol (13).
Correlation:
83 patient samples (urine) are correlated with a commercial
reagent
taken as reference according to the recommendations found in
the
CLSI (NCCLS), EP9-A2 protocol (14). Values ranged from 0.27 to
4.40
mmol/l.
The equation for the allometric line obtained using
Passing-Bablock
regression procedure (15)is:
Y = 0.90 x - 0.01 with a correlation coefficient r2= 0.9885.
Interferences:
Other limitations are given by Young as a list of drugs and
preanalytical
variables known to affect this methodology (16,17).
Conversion factor:mmol/l x 40.1 = mg/l
Calibration stability:
The reagent is calibrated on Day 0. The calibration stability is
checked
by testing 2 control specimens.
The calibration stability is 7 days.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Application release: 2.xx
WarningIt is the users responsibility to verify that this
document is applicable
to the reagent used.
Reference1. Thomas L. Clinical Laboratory Diagnostics. 1sted.
Frankfurt: TH-
Books Verlagsgesellschaft; 1998. p. 192-202.
2. Endres D.B., Rude R.K. Mineral and bone metabolism. In:
Burtis
C.A., Ashwood E.R., editors. Tietz Textbook of Clinical
Chemistry.
3rded. Philadelphia: W.B. Saunders Company; 1999. p.
1395-1457.
3. Matkovic V., Llich J.Z.; Andon M.B.; Hsieh L.C., Tzagournis
M.A.,
Lagger B.J.; Goel PK., Am. J. Clin. Nutr., 1995,
62(2):417-25.
4. Connerty HV, Briggs AR.: Clin. Chem., 1965; 11: 716-28..5.
Connerty HV, Briggs AR.: Am. J. Clin. Path., 1966; 45: 290-6.
6. Gindler EM, Kin JD, Am.: J. Clin. Path., 1972; 58:
376-82.
7. Bauer PJ Anal.: Biochem, 1981; 110: 61-72.
8. NCCLS. Urinalysis and collection, transportation and
preservation
of urine specimen; Approved guideline - 2nd Edition, NCCLS
document GP16-A2, Vol.21, No 19.
9. Use of anticoagulants in diagnostic laboratory
investigations. WHO
publication WHO/DIL/LAB/99.1 Rev.2, 2002.
10. Protocols for determination of limits of detection and
limits of
quantitation, Approved Guideline, CLSI (NCCLS) document
EP17-A,
Vol. 24, No. 34, 2004.
11. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de
validation
de techniques (document B), Ann. Biol. Clin., 1986, 44,
686-745.
12. Evaluation of Precision Performance of Clinical Chemistry
Devices,Approved Guideline, CLSI (NCCLS) document EP5-A, Vol. 19,
No. 2,
february 1999.
13. Evaluation of the Linearity of Quantitative Analytical
Methods,
Approved Guideline, CLSI (NCCLS) document EP6-A, Vol. 23,
No.
16, april 2003.
14. Method Comparison and Bias Estimation Using Patient
Samples,
Approved Guideline, 2nded., CLSI (NCCLS) document EP9-A2,
Vol.
22, No. 19, 2002.
15. Passing H., Bablock W. A new biometrical procedure for
testing the
equality of measurements from two different analytical
methods.
J. Clin. Chem. Clin. Biochem. 1983; 21: 709-20.
16. Young D.S., Effects of Preanalytical Variables on
Clinical
Laboratory Tests, 2nd
Edition, Washington, DC, AACC Press, 1997,3: 120-132.
17. Young D.S., Effects of Drugs on Clinical Laboratory Tests,
4th
Edition, Washington, DC, AACC Press, 1995, 3: 143-163.
Mean value mmol/l CV %
Control specimen 1 1.75 2.27
Control specimen 2 2.55 1.82
Specimen 1 1.18 6.58
Specimen 2 2.71 2.10
Specimen 3 4.40 1.98
Haemoglobin: No significant influence is observed up to 290
mol/l
(500 mg/dl).
Triglycerides: No significant influence is observed up to 7
mmol/l
(612.5 mg/dl).
(as Intralipid, representative of lipemia)
Direct Bilirubin:No significant influence is observed up to 438
mol/l
(25.6 mg/dl).
Acidification No significant influence is observed up to pH
2.
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Calcium CP
ABX Pentra
2007/09/06A93A00132N EN
A11A01633
66 ml
16.5 ml
HORIBA ABX
BP 729034184 Montpellier- cedex 4 - France
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
ABX Pentra Calcium CPRef.: A11A01633Volume R1: 66 mlVolume R2:
16.5 ml
Diagnostic reagent for quantitative in-vitrodetermination of
Calcium in serum, plasmaor urine.
Clinical Interest (1,2)Calcium plays an essential role in many
cell functions: intracellularly
in muscle contraction and glycogen metabolism, extracellularly,
in
bone mineralization, in blood coagulation and in transmission of
nerve
impulses. Calcium is present in plasma in three forms: free,
bound to
proteins or complexed with anions as phosphate, citrate
andbicarbonate. Decreased total calcium levels can be associated
with
diseases of the bone apparatus (especially osteoporosis),
kidney
diseases (especially under dialysis), defective intestinal
absorption
and hypoparathyroidism. Increased total calcium can be measured
in
hyperparathyroidism, malignant diseases with metastases and
sarcoidosis. Calcium measurements also help in monitoring of
calcium
supplementation mainly in the prevention of osteoporosis.
MethodPhotometric test using ortho-cresolphtalein complexone
(OPC).
Cresolphthalein complexone reacts with calcium ions in
alkaline
medium forming a red-violet color. Interference by magnesium
is
eliminated by addition of 8-hydroxyquinoline.
ReagentsABX Pentra Calcium CPis ready-to-use.
ABX Pentra Calcium CP should be used according to this
reagentnotice. HORIBA ABX cannot guarantee its performance if
used
otherwise.
HandlingRemove both caps of the cassette. If present, remove
foam by using a
plastic pipette. Position the respective protective cap, ref.
GBM0969
on R1 and Ref. GBM0970 on R2 and place in the refrigerated
ABX
Pentra 400 reagent compartment.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)10 x 3 ml
(lyophilisate)
Reagent 1: Ethanolamine pH 10.7 0.75 mol/l
Detergents
Reagent 2: o-Cresolphthalein complexone 0.3 mmol/l
8-Hydroxyquinoline 34.5 mmol/l
Hydrochloric acid pH 1.1 100 mmol/l
ControlFor internal quality control, use:
ABX Pentra N Control, Ref. A11A01653 (not included)10 x 5 ml
(lyophilisate)ABX Pentra P Control, Ref. A11A01654 (not included)10
x 5 ml (lyophilisate)
ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)1 x
10 ml + 1 x 10 ml
Each control should be assayed daily and/or after each
calibration.
The frequency of controls and the confidence intervals
should
correspond to laboratory guidelines and country-specific
directives.
The results must be within the range of the defined confidence
limits.
Each laboratory should establish a procedure to follow if the
results
exceed these confidence limits.
Materials required but not provided Automated clinical chemistry
analyser
Standard laboratory equipment.
Specimen Serum. heparin Plasma.
Urine.
Do not use EDTA plasma.
Add 10 ml of concentrated HCl to 24 h urine and heat the
specimen to
dissolve calcium oxalate.
Stability in: Serum /Plasma: 7 days at 20 - 25 C
3 weeks at 4 - 8 C
8 months at - 20 C
Urine: 2 days at 20 - 25 C
4 days at 4 - 8 C
3 weeks at - 20 C
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Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
Reference range (2)
Storage and StabilityReagents, in unopened cassettes, are stable
up to the expiry date on
the label if stored at 2-8C, protected from light, and
contamination
is avoided.
Dont allow to stand open, otherwise the pH decreases because of
CO2absorption from the air.
Stability after opening: refer to the paragraph Performance on
ABX
Pentra 400.
Do not freeze the reagents.
Assay ProcedureTest instructions for other automated systems
than ABX Pentra 400 are
available on request.
Waste ManagementPlease refer to local legal requirements.
General Precautions1. This reagent is for professional
in-vitrodiagnostic use only.
2. As calcium is an ubiquitous ion, essential precaution must be
taken
against accidental contamination. Only use disposable
materials.
3. Take the necessary precautions for the use of laboratory
reagents.
4. The reagent cassettes are disposable and should be disposed
of in
accordance with the local legal requirements.
5. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below
have been obtained on the ABX
Pentra 400 analyser.
Serum, Plasma
Number of tests: 250 tests
On board Reagent Stability:Once opened, the reagent cassette
placed in the refrigerated ABX
Pentra 400 compartment is stable for 31 days.
Sample volume: 4 l/test
Detection limit:The detection limit is determined according to
the Valtec protocol (5)
and equals 0.04 mmol/l.
Accuracy and Precision: Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls
are
tested 20 times according to the recommendations found in the
Valtec
protocol (5).
Reproducibility (run-to-run precision)
A variance analysis is carried out for 6 days out of 2 specimens
of low
and high levels and 2 controls.
Linearity and Measuring Range:The reagent linearity is
determined according to the recommendations
found in the NCCLS, EP6-P protocol (7).
Low linearity: 0.04 mmol/l
High linearity: 5 mmol/l
Correlation:100 patient samples are correlated with another
method taken as
reference according to the recommendations found in the NCCLS,
EP9-
A2 protocol (8).The equation for the allometric line obtained
is:
Y = 0.97 x + 0.03 with a correlation coefficient r2= 0.9907
.
Interferences:
Conversion factor:mmol/l x 40 = mg/l
Calibration stabilitya
:The reagent is calibrated on Day 0. The calibration stability
is checked
by testing 2 control specimens.
The calibration stability is 1 day.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Application release: 5.xx
Serum / Plasma: 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l)
Urine: Women:
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Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
Urine
Number of tests: 250 tests
On board Reagent Stability:Once opened, the reagent cassette
placed in the refrigerated ABX
Pentra 400 compartment is stable for 31 days.
Sample volume: 4 l/test
Detection limit:The detection limit is determined according to
the Valtec protocol (5)
and equals 0.03 mmol/l.
Accuracy and Precision: Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls
are
tested 20 times according to the recommendations found in the
Valtec
protocol (5).
Reproducibility (run-to-run precision)2 specimens of low and
high levels and 2 controls are tested in
duplicate for 20 days (2 series per day) according to the
recommendations found in the NCCLS, EP5-A protocol (6).
Linearity and Measuring Range:The reagent linearity is
determined according to the recommendations
found in the NCCLS, EP6-P protocol (7).
Low linearity: 0.03 mmol/l.High linearity: 6 mmol/l.
Correlation:100 patient samples are correlated with a commercial
reagent taken as
reference according to the recommendations found in the NCCLS,
EP9-
A2 protocol (8).
The equation for the allometric line obtained is:
Y = 0.97 x - 0.09 with a correlation coefficient r2= 0.98.
Interferences:
Conversion factor:mmol/l x 40 = mg/l
Calibration stabilitya:The reagent is calibrated on Day 0. The
calibration stability is checked
by testing 2 control specimens.
The calibration stability is 1 day.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Application release: 7.xx
WarningIt is the users responsibility to verify that this
document is applicable
to the reagent used.
Reference1. Thomas L. Clinical Laboratory Diagnostics. 1sted.
Frankfurt: TH-
Books Verlagsgesellschaft; 1998. p. 192-202.
2. Endres D.B., Rude R.K. Mineral and bone metabolism. In:
Burtis
C.A., Ashwood E.R., editors. Tietz Textbook of Clinical
Chemistry.
3rded. Philadelphia: W.B. Saunders Company; 1999. p.
1395-1457.
3. Baginski E.S., Marie S.S., Clark W.L., Zak B. Direct
microdetermination of serum calcium. Clin. Chim. Acta 1973;
46:46-54.
4. Sarkar BCR., Chauhan UPS. A new method of determining
microquantities of calcium in biological materials. Anal. Biochem.
1967;
20:155-166.
5. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de
validation
de techniques (document B), Ann. Biol. Clin., 1986, 44,
686-745.6. Evaluation of Precision Performance of Clinical
Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
7. Evaluation of the Linearity of Quantitative Analytical
Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
8. Method Comparison and Bias Estimation Using Patient
Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22,
No.
19, 2002.
Mean value mmol/l CV %
Normal control 1.69 0.71
Pathological control 3.15 0.70
Specimen 1 1.09 0.64
Specimen 2 2.96 0.44
Specimen 3 7.22 1.37
Mean value mmol/l CV %
Normal control 1.64 2.44
Pathological control 3.11 2.21
Specimen 1 1.45 3.15
Specimen 2 6.20 2.91
Haemoglobin: No significant influence is observed up to 55
mol/l.
a.Modification from index M to N: Modification of calibration
stability.
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Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
-
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Calcium CP
ABX Pentra
Use in reagent rack
2008/04/21A93A01182G EN
A11A01633
66 ml
16.5 ml
HORIBA ABX
BP 729034184 Montpellier- cedex 4 - France
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
ABX Pentra Calcium CP (Rack)Use in reagent rackRef. :
A11A01633Volume R1: 66 mlVolume R2: 16.5 ml
Diagnostic reagent for quantitative in-vitrodetermination of
Calcium in serum, plasmaor urine.
Clinical Interest (1,2)Calcium plays an essential role in many
cell functions: intracellularly
in muscle contraction and glycogen metabolism, extracellularly,
in
bone mineralization, in blood coagulation and in transmission of
nerve
impulses. Calcium is present in plasma in three forms: free,
bound to
proteins or complexed with anions as phosphate, citrate
andbicarbonate. Decreased total calcium levels can be associated
with
diseases of the bone apparatus (especially osteoporosis),
kidney
diseases (especially under dialysis), defective intestinal
absorption
and hypoparathyroidism. Increased total calcium can be measured
in
hyperparathyroidism, malignant diseases with metastases and
sarcoidosis. Calcium measurements also help in monitoring of
calcium
supplementation mainly in the prevention of osteoporosis.
MethodPhotometric test using ortho-cresolphtalein complexone
(OPC).
Cresolphthalein complexone reacts with calcium ions in
alkaline
medium forming a red-violet color. Interference by magnesium
is
eliminated by addition of 8-hydroxyquinoline.
ReagentsABX Pentra Calcium CPis ready-to-use.
ABX Pentra Calcium CP should be used according to this
reagent
notice. HORIBA ABX cannot guarantee its performance if used
otherwise.
HandlingTransfer the required volume of Reagent 1in a container
15, 10 or 4 ml.
Transfer the required volume of Reagent 2in a container 10 or 4
ml.
Reagent 1 and Reagent 2 should be placed on the same reagent
rack
sector A, B or C (see diagram below, sector A is taken as an
example).
Reagent 1: Ethanolamine pH 10.7 0.75 mol/l
Detergents
Reagent 2: o-Cresolphthalein complexone 0.3 mmol/l
8-Hydroxyquinoline 34.5 mmol/l
Hydrochloric acid pH 1.1 100 mmol/l
Place Reagent 1in position 1 of one available sector using
either:
Reagent container 15 ml
Reagent container 10 ml + its specific adaptor
Reagent container 4 ml + its specific adaptor
Place Reagent 2in position 2 of same selected sector using
either:
Reagent container 10 ml
Reagent container 4 ml + its specific adaptor
Place the reagent rack in the refrigerated ABX Pentra 400
reagent
compartment.
Important : Discard the remaining reagent at the end of the
day.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)
10 x 3 ml (lyophilisate)
ABX Pentra Calcium CPReagent 2
ABX Pentra Calcium CP
Reagent 1
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22/111
Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
ControlFor internal quality control, use:
ABX Pentra N Control, Ref. A11A01653 (not included)
10 x 5 ml (lyophilisate)
ABX Pentra P Control, Ref. A11A01654 (not included)
10 x 5 ml (lyophilisate)
ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)
1 x 10 ml + 1 x 10 ml
Each control should be assayed daily and/or after each
calibration.
The frequency of controls and the confidence intervals
should
correspond to laboratory guidelines and country-specific
directives.
The results must be within the range of the defined confidence
limits.
Each laboratory should establish a procedure to follow if the
results
exceed these confidence limits.
Materials required but not provided Automated clinical chemistry
analyser
Standard laboratory equipment.
Specimen Serum.
heparin Plasma.
Urine.
Do not use EDTA plasma.
Add 10 ml of concentrated HCl to 24 h urine and heat the
specimen to
dissolve calcium oxalate.
Reference range (2)
Storage and StabilityReagents, in unopened cassettes, are stable
up to the expiry date on
the label if stored at 2-8C, protected from light, and
contamination
is avoided.
Dont allow to stand open, otherwise the pH decreases because of
CO2absorption from the air.
Stability after opening: 28 days if the reagents are stored in a
capped
cassette between 2 and 8C.
Do not freeze the reagents.
Assay ProcedureTest instructions for other automated systems
than ABX Pentra 400 are
available on request.
Waste ManagementPlease refer to local legal requirements.
General Precautions1. This reagent is for professional
in-vitrodiagnostic use only.
2. As calcium is an ubiquitous ion, essential precaution must
be
taken against accidental contamination. Only use disposable
materials.
3. Take the necessary precautions for the use of laboratory
reagents.4. The reagent cassettes are disposable and should be
disposed of in
accordance with the local legal requirements.
5. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below
have been obtained on the ABX
Pentra 400 analyser.
Serum, Plasma
Number of tests: 250 tests
Sample volume: 4 l/test
Detection limit:
The detection limit is determined according to the Valtec
protocol (5)
and equals 0.04 mmol/l.
Accuracy and Precision:
Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls
are
tested 20 times according to the recommendations found in the
Valtec
protocol (5).
Reproducibility (run-to-run precision)
A variance analysis is carried out for 6 days out of 2 specimens
of low
and high levels and 2 controls.
Stability in: Serum /Plasma: 7 days at 20 - 25 C3 weeks at 4 - 8
C
8 months at - 20 C
Urine: 2 days at 20 - 25 C
4 days at 4 - 8 C
3 weeks at - 20 C
Serum / Plasma: 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l)
Urine: Women:
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Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
Linearity and Measuring Range:
The reagent linearity is determined according to the
recommendations
found in the NCCLS, EP6-P protocol (7).
Low linearity: 0.04 mmol/l
High linearity: 5 mmol/l
Correlation:
100 patient samples are correlated with another method taken
as
reference according to the recommendations found in the NCCLS,
EP9-
A2 protocol (8).
The equation for the allometric line obtained is:
Y = 0.97 x + 0.03 with a correlation coefficient r2= 0.9907
.
Interferences:
Conversion factor:
mmol/l x 40 = mg/l
Calibration stability:
The reagent is calibrated on Day 0. The calibration stability is
checked
by testing 2 control specimens.
The calibration stability is 4 hours.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Application releasea: 3.xx
Urine
Number of tests: 250 tests
Sample volume: 4 l/test
Detection limit:
The detection limit is determined according to the Valtec
protocol (5)and equals 0.03 mmol/l.
Accuracy and Precision:
Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls
are
tested 20 times according to the recommendations found in the
Valtec
protocol (5).
Reproducibility (run-to-run precision)
2 specimens of low and high levels and 2 controls are tested
in
duplicate for 20 days (2 series per day) according to the
recommendations found in the NCCLS, EP5-A protocol (6).
Linearity and Measuring Range:
The reagent linearity is determined according to the
recommendations
found in the NCCLS, EP6-P protocol (7).
Low linearity: 0.03 mmol/l.
High linearity: 6 mmol/l.
Correlation:
100 patient samples are correlated with a commercial reagent
taken as
reference according to the recommendations found in the NCCLS,
EP9-A2 protocol (8).
The equation for the allometric line obtained is:
Y = 0.97 x - 0.09 with a correlation coefficient r2= 0.98.
Interferences:
Conversion factor:
mmol/l x 40 = mg/l
Calibration stability:
The reagent is calibrated on Day 0. The calibration stability is
checked
by testing 2 control specimens.
The calibration stability is 4 hours.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Application releaseb: 3.xx
WarningIt is the users responsibility to verify that this
document is applicable
to the reagent used.
Haemoglobin: No significant influence is observed up to 195
mol/l.
Triglycerides: No significant influence is observed up to 7
mmol/l.
Total Bilirubin: No significant influence is observed up to 101
mol/l.
Direct Bilirubin: No significant influence is observed up to
1357 mol/l
a. Modification from index F to G: suppression of minor
index.
Mean value mmol/l CV %
Normal control 1.69 0.71
Pathological control 3.15 0.70
Specimen 1 1.09 0.64
Specimen 2 2.96 0.44
Specimen 3 7.22 1.37
Mean value mmol/l CV %Normal control 1.64 2.44
Pathological control 3.11 2.21
Specimen 1 1.45 3.15
Specimen 2 6.20 2.91
Haemoglobin: No significant influence is observed up to 55
mol/l.
b. Modification from index F to G: suppression of minor
index.
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Calcium CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
Reference1. Thomas L. Clinical Laboratory Diagnostics. 1sted.
Frankfurt: TH-
Books Verlagsgesellschaft; 1998. p. 192-202.
2. Endres D.B., Rude R.K. Mineral and bone metabolism. In:
Burtis
C.A., Ashwood E.R., editors. Tietz Textbook of Clinical
Chemistry.
3rded. Philadelphia: W.B. Saunders Company; 1999. p.
1395-1457.
3. Baginski E.S., Marie S.S., Clark W.L., Zak B. Direct
microdetermination of serum calcium. Clin. Chim. Acta 1973;
46:
46-54.
4. Sarkar BCR., Chauhan UPS. A new method of determining
micro
quantities of calcium in biological materials. Anal. Biochem.
1967;
20:155-166.
5. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de
validation
de techniques (document B), Ann. Biol. Clin., 1986, 44,
686-745.
6. Evaluation of Precision Performance of Clinical Chemistry
Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
7. Evaluation of the Linearity of Quantitative Analytical
Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
8. Method Comparison and Bias Estimation Using Patient
Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22,
No.
19, 2002.
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Cholesterol CP
ABX Pentra
2008/11/17A93A00142K EN
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
A11A01634
90 ml
HORIBA ABX
BP 729034184 Montpellier - cedex 4 - France
ABX Pentra Cholesterol CPRef.: A11A01634Volume: 90 ml
Diagnostic reagent for quantitative in-vitrodetermination of
Cholesterol in serum or plasma.
Clinical InterestCholesterol is a component of cell membranes
and a precursor for
steroid hormones and bile acids synthesized by body cells
and
absorbed with food (1). Cholesterol is transported in plasma
via
lipoproteins, namely complexes between lipids and
apolipoproteins
(1). There are four classes of lipoproteins: high density
lipoproteins(HDL), low density lipoproteins (LDL), very low density
lipoproteins
(VLDL) and chylomicrons. While LDL is involved in the
cholesterol
transport to the peripheral cells, HDL is responsible for the
cholesterol
uptake from the cells. The four different lipoprotein classes
show
distinct relationship to coronary atherosclerosis (1).
LDL-cholesterol
(LDL-C) contributes to atherosclerotic plaque formation within
the
arterial intima and is strongly associated with coronary heart
disease
(CHD) and related mortality. Even with total cholesterol within
the
normal range an increased concentration of LDL-C indicates high
risk.
HDL-C has a protective effect impeding plaque formation and
shows an
inverse relationship to CHD prevalence. In fact, low HDL-C
values
constitute an independent risk factor. The determination of
the
individual total cholesterol (TC) level is used for screening
purposes
while for a better risk assessment it is necessary to
measure
additionally HDL-C and LDL-C.
In the last few years several controlled clinical trials using
diet, life
style changes and / or different drugs (especially HMG CoA
reductase
inhibitors [statins]) have demonstrated that lowering total
cholesterol
and LDL-C levels reduce drastically CHD risk (2).
MethodCHOD-PAP: enzymatic photometric test.
Determination of cholesterol after enzymatic hydrolysis and
oxidation
(3,4). The colorimetric indicator is quinoneimine which is
generated
from 4-aminoantipyrine and phenol by hydrogen peroxide under
the
catalytic action of peroxidase (Trinders reaction) (3).
(CHE = Cholesterol Esterase, CHO = Cholesterol oxydase, POD =
Peroxidase)
Cholesterol ester + H2O Cholesterol + Fatty acidCHE
Cholesterol + O2 Cholesterol-3-one + H2O2CHO
2H2O2+ 4-Aminoantipyrine + Phenol Quinoneime + 4H2OPOD
ReagentsABX Pentra Cholesterol CPis ready-to-use.
ABX Pentra Cholesterol CPshould be used according to this
reagent
notice. HORIBA ABX cannot guarantee its performance if used
otherwise.
HandlingRemove the cap of the cassette, place in the
refrigerated ABX Pentra
400 reagent compartment.
If present, remove foam by using a plastic pipette.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)
10 x 3 ml (lyophilisate)
Reagent: Goods buffer pH 6.7 50 mmol/l
Phenol 5 mmol/l
4-Aminoantipyrine 0.3 mmol/l
Cholesterol esterase (CHE) 200 U/lCholesterol oxidase (CHO) 50
U/l
Peroxidase (POD) 3 kU/l
Sodium azide 0.95 g/l
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Cholesterol CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
ControlFor internal quality control, use:
ABX Pentra N Control, Ref. A11A01653 (not included)
10 x 5 ml (lyophilisate)
ABX Pentra P Control, Ref. A11A01654 (not included)
10 x 5 ml (lyophilisate)
Each control should be assayed daily and/or after each
calibration.
The frequency of controls and the confidence intervals
should
correspond to laboratory guidelines and country-specific
directives.
The results must be within the range of the defined confidence
limits.
Each laboratory should establish a procedure to follow if the
results
exceed these confidence limits.
Materials required but not provided Automated clinical chemistry
analyser
Standard laboratory equipment.
Specimen Serum.
Heparin Plasma or EDTA Plasma.
Reference range (5)
The European Task Force on Coronary Prevention recommends to
lower
TC concentration to less than 190 mg/dl (5.0 mmol/l) and
LDL-
cholesterol to less than 115 mg/dl (3.0 mmol/l) (2).
Storage and StabilityReagents, in unopened cassettes, are stable
up to the expiry date on
the label if stored at 2-8C, protected from light and
contamination is
avoided.
Stability after opening : refer to the paragraph Performance on
ABX
Pentra 400.
Do not freeze the reagents.
Note: It has to be mentioned, that the measurement is not
influenced
by occasionally occurring color changes, as long as the
absorbance of
the reagent is 240 mg/dl (>6.2 mmol/l)
Mean value mmol/l CV %
Normal control 2.92 0.82
Pathological control 4.81 0.74
Specimen 1 3.03 1.21
Specimen 2 4.93 0.53
Specimen 3 10.04 0.62
Mean value mmol/l CV %
Normal control 2.83 2.96
Pathological control 4.74 2.34
Specimen 1 4.40 2.80
Specimen 2 6.45 3.01
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Cholesterol CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
Linearity and Measuring Range:
The reagent linearity is determined according to the
recommendations
found in the NCCLS, EP6-P protocol (8).
Low linearity: 0.09 mmol/l.
High linearity: 15 mmol/l.
Correlation:
102 patient samples are correlated with a commercial reagent
taken as
reference according to the recommendations found in the NCCLS,
EP9-
A2 protocol (9).
The equation for the allometric line obtained is:
Y = 1.00 x - 0.4 with a correlation coefficient r2= 0.97.
Interferences:
Calibration stability:
The reagent is calibrated on Day 0. The calibration stability is
checked
by testing 2 control specimens.
The calibration stability is at least 8 days.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Conversion factor:
mmol/l x 0.387 = g/l
mmol/l x 38.7 = mg/dl
Application releasea: 6.xx
WarningIt is the users responsibility to verify that this
document is applicable
to the reagent used.
Reference1. Rifai N., Bachorik P.S., Albers J.J. Lipids,
lipoproteins and
apolipoproteins. In: Burtis C.A., Ashwood E.R., editors.
Tietz
Textbook of Clinical Chemistry. 3rded. Philadelphia: W.B.
Saunders
Company; 1999. p. 809-861.
2. Recommendation of the Second Joint Task Force of European
and
other Societies on Coronary Prevention. Prevention of
coronary
heart disease in clinical practice. Eur. Heart J. 1998; 19,
1434-
1503.
3. Artiss J.D., Zak B. Measurement of cholesterol concentration.
In:
Rifai N., Warnick G.R., Dominiczak M.H., eds. Handbook of
lipoprotein testing. Washington: AACC Press, 1997, 99-114.
4. Deeg R., Ziegenhorn J. Kinetic enzymatic method for
automated
determination of total cholesterol in serum. Clin. Chem. 1983;
29,
1798-1802.
5. Schaefer E.J., McNamara J. Overview of the diagnosis and
treatment of lipid disorders. In: Rifai N., Warnick G.R.,
Dominiczak
M.H., eds. Handbook of lipoprotein testing. Washington: AACC
press, 1997, 25-48.
6. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de
validation
de techniques (document B), Ann. Biol. Clin., 1986, 44,
686-745.
7. Evaluation of Precision Performance of Clinical Chemistry
Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
8. Evaluation of the Linearity of Quantitative Analytical
Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
9. Method Comparison and Bias Estimation Using Patient
Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22,
No.
19, 2002.Haemoglobin: No significant influence is observed up to
195 mol/l
Triglycerides: No significant influence is observed up to 7
mmol/l
Total Bilirubin: No significant influence is observed up to 350
mol/l
Direct Bilirubin: No significant influence is observed up to 117
mol/l
a. Modification from index J to K: new application release.
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Cholesterol CP
ABX Pentra
S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
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CO2RTU
ABX Pentra
2007/07/05A93A00172I EN
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
A11A01645
2 x 20 ml
HORIBA ABX
BP 729034184 Montpellier - cedex 4 - France
ABX Pentra CO2RTURef.: A11A01645Volume: 2 x 20 ml
Diagnostic reagent for quantitative in-vitrodetermination of
Bicarbonate / total CO2in serum or plasma.
Clinical Interest (1)Plasmatic bicarbonates are one of the
principle buffer of the organism.
Their measurement is used in the diagnosis of the
acid-base-balance
in the blood. This balance is based on the
Henderson-Hasselbach
equation (pH=pK+log[bicarbonates/apCO2]) which implies that
all
compensation mechanisms are intended for maintening the
relation(bicarbonates/apCO2) constant.
Elevated and decreased values indicate disorders associated
with
disturbances of the metabolic and respiratory systems.
MethodEnzymatic test using phosphoenolpyruvate carboxylase
(PEPC) and a
stable NADH analog.
The reaction disturbs following equilibrium:
(PEPC = Phosphoenolpyruvate carbolyxase, MDH = Malate
Dehydrogenase)
This results in a conversion of CO2to bicarbonate (HCO3-) which
then
is included in the reaction. Therefore the total
CO2concentration is
measured.
The decrease of reduced cofactor concentration is measured at
405 nm
and is proportional to the concentration of total carbon dioxide
in the
sample.
Reagents
ABX Pentra CO2RTUis ready-to-use.
ABX Pentra CO2RTUshould be used according to this reagent
notice.HORIBA ABX cannot guarantee its performance if used
otherwise.
Reagent: Buffer pH 7.5
Phosphoenolpyruvate (PEP) 12.5 mmol/l
Phosphoenolpyruvate carboxylase (PEPC) >400 U/l
Malate dehydrogenase (MDH) >4100 U/l
NADH analog 0.6 mmol/l
Activators, stabilizers, surfactant, preservative
Phosphoenolpyruvate + HCO3- Oxaloacetate + H2PO4
-PEPC + Mg2+
Oxaloacetate + Cofactor red. Malate + CofactorMDH
CO2+ H2O H+ + HCO3
-H2CO3
HandlingTransfer the necessary Reagent 1volume for one day of
tests into areagent container 15, 10 or 4 ml.
Place Reagent 1in position 1 of one available sector using
either: Reagent container 15 ml
Reagent container 10 ml + its specific adaptor
Reagent container 4 ml + its specific adaptor
Place the reagent rack in the refrigerated ABX Pentra 400
reagent
compartment. Wait for 3 hours to stabilize the reagent.
Important: Discard the remaining reagent at the end of the
day.
CalibratorFor calibration, use:
ABX Pentra CO2Cal, Ref. A11A01648 (not included)3 x 3 ml
ABX Pentra CO2 RTUReagent 1
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CO2RTU
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
ControlFor internal quality control, use:
ABX Pentra CO2Control, Ref. A11A01650 (not included)3 x 3 ml
Each control should be assayed daily and/or after each
calibration.
The frequency of controls and the confidence intervals
should
correspond to laboratory guidelines and country-specific
directives.
The results must be within the range of the defined confidence
limits.
Each laboratory should establish a procedure to follow if the
results
exceed these confidence limits.
Materials required but not provided
Automated clinical chemistry analyser Standard laboratory
equipment.
Specimen Serum.
heparin Plasma.
1. Serum or plasma should be separated from cells
immediately.
2. Exposure of samples to air should be minimized.
3. Samples should be stored tightly sealed to prevent loss of
carbon
dioxide and assayed as soon as possible after collection.
4. Do not use icteric samples.
Reference range (1)Adults:22 - 29 mmol/l (mEq/l).
Storage and StabilityReagents, in unopened vials, are stable up
to the expiry date on the
label if stored at 2 - 8 C protected from light and
contamination is
avoided.
Once opened, the ABX Pentra CO2RTU reagentis stable for 28
dayswhen stored at 2-8C.
Do not freeze the reagent.
Assay ProcedureTest instructions for other automated systems
than ABX Pentra 400 are
available on request.
Waste ManagementPlease refer to local legal requirements.
General Precautions1. This reagent is for professional
in-vitrodiagnostic use only.
2. Take the necessary precautions for the use of laboratory
reagents.
3. The reagent vials should be discarded after use.
4. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below
have been obtained on the ABX
Pentra 400 analyser.
Number of tests: 200 tests
Sample volume: 3 l/test
Detection limit:The detection limit is determined according to
the Valtec protocol (4)and equals 1.8 mmol/l.
Accuracy and Precision: Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 1 control
are
tested 20 times according to the recommendations found in the
Valtec
protocol (4).
Reproducibility (run-to-run precision)
2 specimens of low and high levels and 1 control are tested
in
duplicate for 20 days (2 series per day) according to the
recommendations found in the NCCLS, EP5-A protocol (5).
Linearity and Measuring Range:The reagent linearity is
determined according to the recommendations
found in the NCCLS, EP6-P protocol (6).
Low linearity: 1.8 mmol/l
High linearity: 60.8 mmol/l, with automatic post-dilution: 121.6
mmol/l.
Correlation:
99 patient samples are correlated with a commercial reagent
taken asreference according to the recommendations found in the
NCCLS, EP9-
A2 protocol (7).
The equation for the allometric line obtained is:
Y = 0.99 x + 0.35 with a correlation coefficient r2= 0.99.
Interferences:
Mean value mmol/l CV %
Normal control 20.4 1.25
Specimen 1 10.9 0.78
Specimen 2 21.3 0.51
Specimen 3 32.0 0.66
Mean value mmol/l CV %
Normal control 20.7 4.77
Specimen 1 9.5 7.7
Specimen 2 31.6 5.93
Haemoglobin: No significant influence is observed up to 195
mol/l
Triglycerides: No significant influence is observed up to 7
mmol/l
Total Bilirubin: No significant influence is observed up to 250
mol/l
Direct Bilirubin: No significant influence is observed up to 370
mol/l
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CO2RTU
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
Calibration stability:The reagent is calibrated on H0. The
calibration stability is checked by
testing 2 control specimens.
The calibration stability is 1 day by discarding the remaining
reagent
at the end of the day.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Application releasea: 3.xx
Warning
It is the users responsibility to verify that this document is
applicableto the reagent used.
Reference1. Mller-Plathe O. Acid base balance and blood gases.
In: Thomas L.,
editor. Clinical laboratory diagnostics. 1sted. Frankfurt: T.H.
Books
Verlagsgesellschaft; 1998. p.318-329.
2. Norris K.A., Atkinson A.R., Smith W.G. Colorimetric
enzymatic
determination of serum total carbon dioxide as applied to
the
Vickers multichannel 300 discrete analyser. Clin. Chem.
1975;21;1093-1101.
3. US patent #5,801,006.
4. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de
validation
de techniques (document B), Ann. Biol. Clin., 1986, 44,
686-745.5. Evaluation of Precision Performance of Clinical
Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
6. Evaluation of the Linearity of Quantitative Analytical
Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
7. Method Comparison and Bias Estimation Using Patient
Samples,
Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22,
No.
19, 2002.
a. Modification from index H to I: suppression of minor
index.
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CO2RTU
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
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Creatinine CP
ABX Pentra
2007/07/04A93A00182M EN
A11A01666
28 ml
28 ml
HORIBA ABX
BP 729034184 Montpellier- cedex 4 - France
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
ABX Pentra Creatinine CPRef.: A11A01666Volume R1: 28 mlVolume
R2: 28 ml
Diagnostic reagent for quantitative in-vitrodetermination of
creatinine in serum,plasma and urine by colorimetry.
Clinical InterestCreatinine is a product of the degradation of
the creatine. It is a tiny
nitrogenised molecule eliminated primarily by the kidneys.
Under
stable conditions of the muscular mass and proteic
contribution,
creatininaemia is an excellent reflection of renal function.
The
determination of urinary creatinine permits the calculation
ofclarification, which is an independent parameter of diuresis
and
proteic contribution.
MethodMeasurement of the formation of a colorimetric complex
between the
creatinine and the alkaline picrate (Jaff). The speed of the
formation
of this complex is proportional to the creatinine present in the
sample.
This kinetic method reduces the effects of interfering
substances.
ReagentsABX Pentra Creatinine CPis ready-to-use.
ABX Pentra Creatinine CPshould be used according to this
reagentnotice. HORIBA ABX cannot guarantee its performances if
used
otherwise.
HandlingRemove both caps of the cassette. If present, remove
foam by using a
plastic pipette. Position the respective protective cap, ref.
GBM0969
on R1 and Ref. GBM0970 on R2 and place it in the position 45of
theABX Pentra 400 reagent compartment.
Important : for a new cassette, wait for 30 minutes to stabilize
thetemperature of the reagent.
CalibratorFor calibration, use:
ABX Pentra MultiCal, Ref. A11A01652 (not included)10 x 3 ml
(lyophilisate)
ControlFor internal quality control, use:
ABX Pentra N Control, Ref. A11A01653 (not included)10 x 5 ml
(lyophilisate)
Reagent 1: Picric acid 8.73 mmol/l
Reagent 2: Sodium hydroxide 312.5 mmol/l
Disodium phosphate 12.5 mmol/l
ABX Pentra P Control, Ref. A11A01654 (not included)10 x 5 ml
(lyophilisate)
ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)1 x
10 ml + 1 x 10 ml
Each control should be assayed daily and/or after each
calibration.
The frequency of controls and the confidence intervals
shouldcorrespond to laboratory guidelines and country-specific
directives.
The results must be within the range of the defined confidence
limits.
Each laboratory should establish a procedure to follow if the
results
exceed these confidence limits.
Materials required but not provided Automated clinical chemistry
analyser
Standard laboratory equipment
Specimen Serum
Plasma in heparin and EDTA
Fresh centrifuged urine
Reference range(7)
We recommended that each laboratory establishes its own
reference
range.
Men Women
Serum/Plasma: 8 - 13 6 - 12 mg/l
0.8 - 1.3 0.6 - 1.2 mg/dl
71 - 115 53 - 106 mol/l
Urine: 0.8 - 2.0 0.6 - 1.8 g/24 h
7.1 - 17.7 5.3 - 15.9 mmol/24 h
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Creatinine CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
Storage and StabilityReagents, in unopened cassettes, are stable
up to the expiry date on
the label if stored at 2-8 C and protected from light.
Stability opening: refer to the paragraph "Performance on ABX
Pentra
400".
Assay ProcedureTest instructions for other automated systems
than ABX Pentra 400 are
available on request.
Waste ManagementPlease refer to local legal requirements.
General Precautions1. Reagent, for professional
in-vitrodiagnostic use only
2. The reagent 2 contains diluted sodium hydroxide and is
consequently irritating to the eyes and the skin. In case of
contact
with eyes, rinse generously with water and consult a
specialist.
Avoid all contact with the skin; use gloves when handling.
3. The reagent cassettes are disposable and should be disposed
of in
accordance with the local legal requirements.
4. Please refer to the MSDS associated with the reagent.
Performance on ABX Pentra 400The performance data listed below
have been obtained on the ABX
Pentra 400 analyser.
Serum, Plasma
Number of tests: 120 tests.
On board Reagent Stability:If the ABX Pentra Creatinine CP
cassette is left on board theinstrument at all times, the cassette
is stable for 21 days.
Sample volume: 13 l/test
Detection limit:The detection limit is determined according to
the Valtec protocol (4)
and equals 10 mol/l.
Accuracy and Precision: Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls
are
tested 20 times according to the recommendations found in the
Valtec
protocol (4).
Reproducibility (run-to-run precision)
A variance analysis out of 2 specimens of medium and high levels
is
carried out (n=30).
Linearity and Measuring Range:The reagent linearity is
determined according to the recommendations
found in the NCCLS, EP6-P protocol (5).
Low linearity: 10 mol/l
High linearity: 1400 mol/l, with automatic post-dilution: 7000
mol/l.
Correlation:100 patient samples are correlated with a commercial
reagent taken as
reference according to the recommendations found in the NCCLS,
EP9-
A2 protocol (6).
The equation for the allometric line obtained is:
Y = 1.08 x + 4.74 with a correlation coefficient r2= 0.993.
Interferences:
Conversion factor:mol/l x 0.113 = mg/l
mol/l x 0.0113 = mg/dl
Calibration stability:The reagent is calibrated each day.
Note: A recalibration is recommended when reagent lots change,
and
when quality control results fall outside the range
established.
Application releasea: 4.xx
Urine
Number of tests: 120 tests.
On board Reagent Stability:If the ABX Pentra Creatinine CP
cassette is left on board theinstrument at all times, the cassette
is stable for 21 days.
Sample volume: 13 l/test
Detection limit:The detection limit is determined according to
the Valtec protocol (4)
and equals 200 mol/l.
Mean value mol/l CV %
Normal control 114 1.58
Pathological control 299 0.66
Specimen 1 53 2.09
Specimen 2 137 0.71
Specimen 3 676 0.39
Mean value mol/l CV %
Specimen 1 111 2.35
Specimen 2 601 1.36
Haemoglobin: No significant influence is observed up to 319
mol/l
Triglycerides: No significant influence is observed up to 7
mmol/l
Total Bilirubin: No significant influence is observed up to 176
mol/l
Direct Bilirubin: No significant influence is observed up to 92
mol/l
Glucose: No significant influence is observed up to 22.5
mmol/l
a.Modification from index L to M: suppression of minor
index.
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Creatinine CP
ABX Pentra
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
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8/10/2019 Substrates P400 En
37/111
Creatinine 120 CP
ABX Pentra
2007/06/28A93A01215C EN
S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 -
SIRET 328 031 042 000 42 - APE 332 B Latest version documents on
www.horiba-abx.com
A11A01868
1 x 27 ml
HORIBA ABX
BP 729034184 Montpellier - cedex 4 - France
ABX Pentra Creatinine 120 CPTest instructions for Mira
instrumentsRef.: A11A01868Volume: 1 x 27 ml
Intended use
Diagnostic reagent for quantitative in-vitrodetermination of
creatinine in serum, plasma andurine by colorimetry.
Clinical Interest (1,2)Creatinine, formed in the muscle, is a
product of the degradation of
creatine phosphate, a high energy storage component.
Creatininaemia
is quite constant (contrary to ureamia), it mainly depends of
the
muscular mass. It is not very modified by food diet, age, sex
or
exercise. Creatinine is extracted out of plasma by glomerular
filtrationand then, eliminated in urine. The determination of
urinary creatinine
permits the calculation of clarification, which is an
independent
parameter of diuresis and proteic contribution.
Crea