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WHO/BS/2013.2226
ENGLISH ONLY
EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION
Geneva, 21 to 25 October 2013
Report on an International Collaborative Study to Establish the 1
st WHO International
Reference Panel for HIV-1 Circulating Recombinant Forms for NAT Assays
C L Morris1, E Wigglesworth
1 and A B Heath
2
Divisions of Virology1 and Biostatistics
2, National Institute for Biological Standards and Control
(NIBSC), Blanche Lane, South Mimms, Potters Bar, Herts EN6 3QG, UK.
Note:
This document has been prepared for the purpose of inviting comments and suggestions on the
proposals contained therein, which will then be considered by the Expert Committee on Biological
Standardization (ECBS). Comments MUST be received by 4 October 2013 and should be
addressed to the World Health Organization, 1211 Geneva 27, Switzerland, attention: Department of
Essential Medicines and Health Products (EMP). Comments may also be submitted electronically
to the Responsible Officer: Dr Ana Padilla at email: [email protected] with a copy to David Wood
Table 9: Estimated Copies or IU /ml (log10) from Quantitative Assays for 3rd IS 10/152
Units Method Lab Log10
Copies or IU/ml
Copie
s ART
10A 5.06
11A 4.96
14A 4.98
Mean 5.00
CAP
01 5.23
03 5.22
10B 5.32
11B 5.05
14B 5.14
16 5.13
17 5.20
Mean 5.18
RHP
12 4.82
18 5.11
20 4.68
Mean 4.87
IH
04 5.10
06A 5.30
09 5.03
13 5.11
IU ART 15 5.17
IH 02 5.03
WHO/BS/2013.2226
Page 19
Assay Codes:
ART Abbott Real Time
CAP Roche cobas Ampliprep/cobas Taqman
RHP Roche HighPure System/cobas Taqman
IH In-House
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
IU/ml (log10)
Neg 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Figure 1: Panel Member 1
NIBSC Code 11/144
BCF01 (Group O)
08 02
05
06A
06B
07
04
09
10A
11A
13
14A
18
12
15
01
03
11B
14B
17
19
10B
16
IH IH
IH
IH
IH
P U
IH
IH
A R T
A R T
IH
A R T
R H P
R H P
A R T
C A P
C A P
C A P
C A P
C A P
P U
C A P
C A P
WHO/BS/2013.2226
Page 20
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
IU/ml (log10)
Neg 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Figure 2: Panel Member 2
NIBSC Code 11/148
MP1307 (CRF 11 GJ)
06A 07
09
04
08
10A
11A
20
02
12
14A
15
18
01
03
05
13
06B
10B
11B
14B
16
17
19
IH P U
IH
IH
IH
A R T
A R T
R H P
IH
R H P
A R T
A R T
R H P
C A P
C A P
IH
IH
IH
C A P
C A P
C A P
C A P
C A P
P U
WHO/BS/2013.2226
Page 21
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
IU/ml (log10)
Neg 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Figure 3: Panel Member 3
NIBSC Code 11/140
P1261 (CRF 02 AG)
08 06A
20
02 04
09
12
13
18
19
01
03
07
10A
10B
11A
11B
14A
14B
15
16
17
06B 05
IH IH
R H P
IH IH
IH
R H P
IH
R H P
P U
C A P
C A P
P U
A R T
C A P
A R T
C A P
A R T
C A P
A R T
C A P
C A P
IH IH
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
IU/ml (log10)
Neg 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Figure 4: Panel Member 4
NIBSC Code 11/102
CM244 (CRF01 AE)
08 02 06A
20
07
09
12
18
01
03
04
10A
11A
11B
13
14A
15
16
17
19
10B
14B
05 06B
IH IH IH
R H P
P U
IH
R H P
R H P
C A P
C A P
IH
A R T
A R T
C A P
IH
A R T
A R T
C A P
C A P
P U
C A P
C A P
IH IH
WHO/BS/2013.2226
Page 22
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
IU/ml (log10)
Neg 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Figure 5: Panel Member 5
NIBSC Code 12/146
96CM1849 (CRF01 A,G,J,U)
06A
20
02
13
18
07
08
09
12
01
03
04
10A
11A
11B
14A
14B
16
17
06B
10B
15
19 05
IH
R H P
IH
IH
R H P
P U
IH
IH
R H P
C A P
C A P
IH
A R T
A R T
C A P
A R T
C A P
C A P
C A P
IH
C A P
A R T
P U IH
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
IU/ml (log10)
Neg 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Figure 6: Panel Member 6
NIBSC Code 12/144
X2456 (CRF BG 24)
02
08
04
06A
07
09
11A
20
01
10A
12
13
14A
15
18
03
10B
11B
14B
16
17
19
06B 05
IH
IH
IH
IH
P U
IH
A R T
R H P
C A P
A R T
R H P
IH
A R T
A R T
R H P
C A P
C A P
C A P
C A P
C A P
C A P
P U
IH IH
WHO/BS/2013.2226
Page 23
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
IU/ml (log10)
Neg 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Figure 7: Panel Member 7
NIBSC Code 11/100
SE9173 (Subtype J)
06A
20
07
09
19
02
04
08
18
01
03
10A
10B
11A
11B
12
13
14A
14B
15
16
17
05 06B
IH
R H P
P U
IH
P U
IH
IH
IH
R H P
C A P
C A P
A R T
C A P
A R T
C A P
R H P
IH
A R T
C A P
A R T
C A P
C A P
IH IH
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
IU/ml (log10)
Neg 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Figure 8: Panel Member 8
NIBSC Code 12/142
X1936 (Subtype C)
06A 02
07
09
20
04
08
10A
11A
18
01
03
10B
12
13
14A
14B
15
16
17
19
06B
11B
05
IH IH
P U
IH
R H P
IH
IH
A R T
A R T
R H P
C A P
C A P
C A P
R H P
IH
A R T
C A P
A R T
C A P
C A P
P U
IH
C A P
IH
WHO/BS/2013.2226
Page 24
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
IU/ml (log10)
Neg 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Figure 9: Panel Member 9
NIBSC Code 11/138
P962 (Subtype G)
06A 07 20 02
08
12
16
18
01
03
04
09
11A
11B
13
14B
17
06B
10A
10B
14A
15
19
05
IH P U R H P IH
IH
R H P
C A P
R H P
C A P
C A P
IH
IH
A R T
C A P
IH
C A P
C A P
IH
A R T
C A P
A R T
A R T
P U
IH
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
IU/ml (log10)
Neg 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Figure 10: Panel Member 10
NIBSC Code 11/146
24203 (CRF ADG)
07
08
20
12
18
19
02
06A
09
11A
13
01
03
04
10A
10B
14A
14B
15
16
17
11B 05
06B
P U
IH
R H P
R H P
R H P
P U
IH
IH
IH
A R T
IH
C A P
C A P
IH
A R T
C A P
A R T
C A P
A R T
C A P
C A P
C A P IH
IH
WHO/BS/2013.2226
Page 25
Appendix 1: Participants
Pavel Hlozek
GeneProof a.s
Vinicni 235
615 00 Brno
CZECH REPUBLIC
Bryan Cobb
Roche
4300 Hacienda Ave
Pleasanton
CA 94588
USA
Indira Hewlett
CBER / FDA
Bldg 29B
Rm 3G-05
9000 Wisconsin Ave
Bethesda
MD 20892
USA
Maria Susana Vitali
Laboratorio de Hemoderivados
Av Valparaiso s/n Ciudad Universitaria
Universidad Nacional de Cordoba
Cordoba
CP X5000HLA
ARGENTINA
Amfumbom Kfutwah
HIV Laboratory
Virology Service
Centre Pasteur du Cameroun
PO Box 1274
Yaoundé
CAMEROON
Susanna Wessberg
Finnish Red Cross Blood Service
Donor Screening and Quality Control
Laboratory
Kivihaantie 7
SF-00310 Helsinki
FINLAND
Christina Wolf
Baxter
Plasma Analytics / Molecular Biology
Industriestrasse 20
1221 Wien
AUSTRIA
Masashi Tatsumi
AIDS Research Centre
National Insitute of Infectious Diseases
1-23-1 Toyama
Shinjuku
Tokyo 162-8640
JAPAN
Veronique Michel-Treil
Covance CLS SA
7 Rue Moise Marcinhes
1217 Meyrin
SWITZERLAND
Linda L Jagodzinski
Walter Reed Army Institute of Research
13 Taft Court
Suite 101
Rockville
MD 20850
USA
Marisa Coelho Adati
INCQS – Fiocruz
Av. Brasil, 4365
Manguinhos
Rio de Janeiro
Jacqueline Prieto
Rontgenvagen 2
PO Box 1427
SE-171 54 Solna
SWEDEN
WHO/BS/2013.2226
Page 26
21040-900
BRAZIL
Erin Wigglesworth
NIBSC
Division of Virology
Blanche Lane
South Mimms
Herts
EN6 3QG
UK
Dr Julia Kress
Paul Ehrlich Institut
Paul Ehrlich Str 51 – 59
63225 Langen
GERMNAY
Angela Light
Covance
8211 SciCor Drive
Indianapolis
IN 46214
USA
Yong Joo Cha
Department of Laboratory Medicine
Chung-Ang University Hosiptal
224-1 Heukseok-dong
Dongjak-gu
Seoul 156-756
SOUTH KOREA
Bharathi Anekella
SeraCare Life Sciences
217 Perry Parkway
Gaitherbburg
MD 20877
USA
Christine Defer
URBM
EFS Nord de France
10-12 bd de Belfort
59 000 Lille
FRANCE
Karen Cristiano/ Giulio Pisani
Biologicals Unit
National Center for Immunobiologicals
Research and Evaluation (CRIVIB)
Istituto Superiore di Sanita
Viale Regina Elena 299
00161 – Rome
ITALY
Dr T Oosterlaken
OLVG
Department of Medical Microbiology
Oosterpark 9
PO Box 95500
1090HM Amsterdam
THE NETHERLANDS
Cristina Alemany
BIOMAT S.A. –Grifols S.A.
PCR Laboratory
c/Llevant nº 11
08150 Parets del Vallès- Barcelona
SPAIN
WHO/BS/2013.2226
Page 27
Appendix 2 – Study Protocol
Evaluation of the1
st HIV-1 NAT CRF panel
Objective.
To assess the ability of various commercial and in-house assays to detect a panel of HIV-1 RNA
subtypes.
Background.
It has been known for some time that different subtypes of HIV-1 exist. There is the major group
known as M consisting of subtypes A –J and more diverse groups of outliers such as group N, P and
O. A few years ago nucleic acid-based tests had a narrow band of specificity targeting the B clade as
this was most predominate in the Western World. Improvements have been made in assay design in
an attempt to detect a wider range of subtypes.
However it is recognised that recombination events have led to a wider diversity of HIV-1 subtypes
and in recent years viruses containing one or more subtype sequence within the genome have
become evident, these viruses have become known as Circulating Recombinant Forms (CRF’s). It is
known from collaborative studies conducted using an HIV-1 NAT panel containing many common
subtypes that predominately circulate within in Europe, North America and Asia, that some assays
are still poor at detecting such subtypes, thus giving a low or negative result on samples that are
known to be positive. In order to allow manufacturers of assays and laboratories running in house
assays to validate an assays ability to detect CRF’s the WHO endorsed the development of the 1st
HIV-1 NAT CRF panel. This panel is being assessed in this collaborative study.
Materials.
The package consists of 10 vials containing representatives from HIV-1 NAT Circulating
Recombinant Forms, a member from diverse HIV groups and a standard subtype C virus, the
members are as follows – C, G, J, O, CRF 01, 02 11, 13, 24 and CRF ADG, the 3rd
International
Standard for HIV-1 NAT is also included. All panel members have been coded.
All panel members and the International Standard have been diluted in HBsAg, anti-HIV and anti
HCV negative human plasma.
CAUTION.
THESE PREPARATIONS ARE NOT FOR ADMINISTRATION TO HUMANS.
All preparations have been heat inactivated at 600C for 1 hour. Successful heat inactivation has been
demonstrated by the use of a commercial assay designed to detect Reverse Transcriptase activity in
a live virus preparation. In all cases no RT activity was seen indicating successful heat inactivation.
However as with all biological preparations the material should be used and discarded according to
your own laboratory safety procedures.
WHO/BS/2013.2226
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Study Design.
You have been sent up to 4* HIV-1 CRF panels (each panel contains 10 members as described
above), up to 4* vials of the International Standard for HIV-1 NAT has also been included, all vials
have been randomly coded Sample 1 - 11.
*(number of vials is dependent on how many ml’s is required in each assay, this information has
been derived from the assays that you indicated on your initial study acceptance form)
For each assay, one panel (samples 1-11) should be reconstituted in 1ml of molecular grade water,
all panel members should be prepared and tested at the same time in a single assay.
Participants are requested to perform two independent assays and where possible to test each sample
in duplicate in each assay.
A fresh vial of each reagent should be used in each assay.
We do not recommend that vials should be used after a freeze thaw cycle.
For Quantitative assays.
Assay samples 1 - 11 undiluted, preferably in duplicate, if sample numbers are restricted by the
assay, then test samples singularly.
Where possible two assays should be carried out on separate occasions.
For Qualitative assays.
Assay samples 1- 11 determine the HIV-1 RNA end-point for each preparation. We suggest using
neat material and 3 tenfold dilutions.
In the subsequent assays participants are requested to assay a minimum of two half log dilutions
either side of the pre-determined end point.
Results.
Results of each assay should be recorded on the appropriate result form included with this
information sheet. A separate methods form is provided so that all relevant information can be
recorded.
WHO/BS/2013.2226
Page 29
All completed forms should be returned to:
Erin Wigglesworth/Clare Morris
Division of Retrovirology
NIBSC
Blanche Lane
South Mimms
Potters Bar
Herts EN6 3QG
UK
Fax: +44 1707 641060
WHO/BS/2013.2226
Page 30
Appendix 3: Material Receipt form
Recipients name
Lab code Number:
Organisation Address
Materials sent
Date sent
Condition of package
Condition of contents
Was the sample still frozen (if applicable)?
Other comments
Date received
Recipients Signature
Please complete and return this form to: Erin Wigglesworth/Clare Morris National Institute for Biological Standards and control Blanche Lane South Mimms Potters Bar Herts. EN6 3QG UK Fax: +44 (0) 1707 641060 [email protected][email protected]