EXTERNAL QUALITY ASSESSMENT SCHEME Evaluation Booklet CARIBBEAN REGION Performance Evaluation Panel OPS0110 C Coordination: Fundação Pró-Sangue Hemocentro de São Paulo Pan American Health Organization International Consortium for Blood Safety Caribbean Epidemiology Centre São Paulo, 20 July 2010
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EXTERNAL QUALITY ASSESSMENT SCHEME
Evaluation Booklet
CARIBBEAN REGION
Performance Evaluation Panel OPS0110 C Coordination: Fundação Pró-Sangue Hemocentro de São Paulo Pan American Health Organization International Consortium for Blood Safety Caribbean Epidemiology Centre
CO = Cut off OD = Optical Density IFI = Indirect Immunofluorescence FNR = False Negative Result FPR = False Positive Result TND = Total of Determinations in Negative Samples TPD = Total of Determinations in Positive Samples
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COUNTRY PARTICIPANTS
Anguilla Princess Alexandra Hospital
Antigua Mount St. Johns Medical Center
Bahamas Rand Memorial Hospital
Bahamas Princess Margaret Hospital
Barbados Queen Elizabeth Hospital
Belize Central Medical Laboratory
Cayman Islands Cayman Islands Health Services, George Town Hospital
Netherlands Antilles Red Cross Blood Bank Foundation
Dominica Medical Laboratory, Princess Margaret Hospital
Grenada Pathology Laboratory, General Hospital
Guyana National Blood Transfusion Service, Public Hospital
Jamaica National Public Health Laboratory
Monserrat Pathology Laboratory
Nevis Alexandra Hospital Laboratory
Saint Lucia Ezra Long Laboratory, Victoria Hospital
St. Kitts Joseph N. France General Hospital
St. Vincent and The Grenadies Pathology Laboratory, Milton Cato Memorial Hospital
Suriname National Blood Bank Suriname Red Cross Society
Turks & Caicos Islands Grand Turk Hospital Laboratory
Trinidad National Blood Transfusion Center One performance evaluation panel (OPS0110C) containing 6 samples with positivity to HIV, HCV, ant-HTLV, Syphilis, ant-T.cruzi and HBsAg were shipped to each participant. The survey samples were undiluted, defibrinated plasma obtained from individual donors and containing 0.05% of Bronidox –L5 as a preservative. Of the 20 participants that were sent the performance evaluation panel, 4 of them (20%) did not return the results.
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Panel OPS0110 C – Target Result
Sample Syphilis HIV ant-HTLV HCV HBsAg ant-T. cruzi 1 X X 2 X X 3 X 4 X X 5 X 6 X X
Characterization tests results of the Performance Evaluation Panel OPS0110 C Tables 1 to 9 show the characterization tests results performed at Fundação Pró-Sangue Hemocentro de São Paulo – Quality Control Department. Optical density and cut-off values of the assays are presented for the 6 samples that comprise the Performance Evaluation Panel OPS0110 C. Table 1 Syphilis
Enzygnost Syphilis Architect Syphilis VDRL Test
39103 77033LP64 0907030290 OD CO CO/OD S CO S/CO Result
Graph 1 shows the number of the tests performed by the 16 participants to each parameter. All 16 respondents performed tests for Syphilis and HBsAg. Fifteen respondents performed test for HIV and HCV, eleven respondents performed test for ant-HTLV and two for ant-T. cruzi. The table 10 shows the false positive and false negative results reported for each parameter. The total of the false negative results reported was 1.8% in 225 determinations performed in positive samples and 5.2% of false positive result in 383 determinations performed in negative samples.
Results reported for each parameter
Table10
Percentage of false negative and false positive results by parameter False Positive % False Negative %
Syphilis 1 1.32 0 0 TND = 76 TPD = 53
HIV 2 2.0 0 0 TND = 100 TPD = 27
Ant-HTLV 0 0 1 2.6 TND = 48 TPD = 38
HCV 12 21.8 0 0 TND = 55 TPD = 75
HBsAg 5 5.3 3 10.7 TND = 94 TPD = 28
Ant-T. cruzi 0 0 0 0 TND = 10 TPD = 4
Total 20 5.2 4 1.8 TND = 383 TPD = 225
TND = Total of determinations performed in negative samples TPD = Total of determinations performed in positive samples
02468
1012141618
Syphilis HIV ant-HTLV HCV HBsAg ant-T. cruzi
Parameter
nº L
abor
ator
ies
Graph 1
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Performance result of the participants The performance qualification “A” was attributed to 9 participants to all tests reported. Five participants had good performance. but reported a few false positive results. Qualification “B1” or “B2” was attributed to them. Qualification “C” was attributed to two participants. Table 11 Participants performance by parameter
Participants HIV HBsAg Syphilis HCV Anti-HTLV ant-T. cruzi 1 A A A A A A 2 A A A A A - 3 A A A A - A 4 A A A A A - 5 A A A A A - 6 A A A A A - 7 A A A A - - 8 A A A A - - 9 A A A - - - 10 B1 A A A - - 11 - A B2 A A - 12 A A A B2 A - 13 A A A A A - 14 A B2 A B2 A - 15 A A A A C - 16 B2 C A A A -
A = 100% of concordance B1 = ≤ 5% of the total of determinations B2 = > 5% of the total of determinations C = False negative result -- = Not performed
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Analysis by Sample Graph 2 show the percentage of the false positive results reported to each sample and the Table 12 shows the rate of false positive results of each sample by parameter. False Positive results (%) reported by sample
Table 12 Rate of false positive results of each sample by parameter.
TND = Total of determinations performed in negative samples TPD = Total of determinations performed in positive samples F.P. = False positive results F.N. = False negative results
Supplemental tests Table 19 shows the confirmatory tests performed by the participants. Table 19 Supplement tests performed by the participants by parameter
Responsable Dra. Márcia Otani Serology - Quality Control Department Fundação Pró-Sangue Hemocentro de São Paulo. Av. Dr. Enéas de Carvalho Aguiar 155 – Cerqueira Cesar – São Paulo. CEP: 05403-000 Tel: 55 11 3061 5544 ext. 353 Fax: 55 11 3088 8317 e-mail: [email protected] or [email protected]