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HIV testing: a practical approach  >  Appendix 2: Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2
This section as pdf  3.55 mbThis section in pdf format


Appendix 2: Characteristics of some selected HIV tests 
for detection of HIV-1 and HIV-2

HIV testing: a practical approach

Acknowledgements
Definitions
Introduction
Why test for HIV?
Deciding which tests to use
Screening blood for transfusion
Implementing HIV testing for individuals
Screening for surveillance
Appendix 1
Appendix 2
Resources
Organisations
Questionnaire

 

 

 

HIV testing: a practical approach    37  Page 38  39  top of page

  Appendix 2: Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2

 

APPENDIX 2 Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2(1)
 

ELISA tests
Name  Detect-HIV Wellcozyme
HIV-1 + 2
Genelavia
Mixt
Innotest
HIV-1/HIV-2 Ab
Abbott
Recombinant
HIV-1/HIV-2 3rd
Generation
HIV-1 and/or HIV-2
Recombigen EIA
Manufacturer  Biochem
Immunsystemes
We llco me
Diagnostics
Sanofi Diagnostics
Pasteur
Innogenetics  Abbott Cambridge
Biotech
Sensitivity 100 100 100 100 100 100
Specificity 97.4 96.9 98.5 97.9 100 100
Positive predictive value at prevalence of 0.01% (6%) 0.4 (71.2)     0.7 (98.6) 0.5 (75.2) 100 (100) 100 (100)

 

Number of tests Per kit (smallest/biggest)  96 96/480 96/480 96 100 (1000) 192
Storage conditions C 2-8C 2-8C 2-8C 2-8C 2-8C 2-8C
Incubation temperature(2) 18-24C 37C and 18-30C 40C and 18-25C 20-25C and 37C 20-25C and 40C 20-25C and 37C
Reader or visual reader reader reader reader reader reader
Equipment needed not provided in the kit(3)  microtitre plate
refrigerator
spectrophotometric
reader
microtitre plate
refrigerator
spectrophotometric
meter
washer
aspiration device
dilution tubes/rack
incubator
microtitre plate
multichannel
refrigerator
spectrophotometric
reader
washer
incubator
refrigerator
spectrophotometric
meter
aspiration device
automatic pipette
incubator
microtitre plate
refrigerator
spectrophotometric
meter
washer
aspiration device
automatic pipette
incubator
refrigerator
spectrophotometric
meter
washer
Time to perform single test for 1 serum/90 sera
(hours/minutes)
1.45/2.30 1.45/2.15  1.40/2.10  
1.50/2.2 5 1.42/2.45 shaken
3.42/4.45 not shaken
2.25/2.55
Ease of performance(4) less easy less easy less easy less easy less easy less easy
Least and largest number of tests run at a time
(no. of controls needed per test)
10 to 90 (and 6c) 2 to 90 (and 6c) 3 to 91 (and 5c) 4 to 92 (and 4c) 1 to 15 (20-assay
incubation tray)
1 to 50 (60-assay
incubation tray)
1 to 8 8
Shelf life at 2 - 8 C if not stated otherwise  9 months 9 months 12 months 6 months 60 days 12 months
Costs per test (supply by WHO, bulk purchase prices)(5)  US$2.5 US$1.5 US$1.5 per 96
(US$0.70 per 480)
US$1.9 US$1.78 per 100
(US$1.66 per 1000)
US$1.65
Suitability for small blood banks(6)  less suitable  less suitable  less suitable  less suitable  less suitable  less suitable 


                      Beneficial characteristics
  disadvantage in some settings



(1) These tests have been tested and approved by WHO. Selection of these tests does not exclude the possibility that others might prove better.
(2) According to recommendations of producer.
(3) Main equipment only. Consumables e.g. reagents, pipette tips, etc. are not included.
(4) 30 parameters of performance e.g. dilution procedure, washing, etc.
(5) Costs as provided by the distributor in Belgium during evaluation (as offered by WHO bulk purchase programme). Costs may have changed since.
(6) High sensitivity and specificity, long shelf life a t ambient temperature, reasonable cost, ease and rapidity of performance.

Adapted from Operational characteristics of commercially available assays to detect antibodies to HIV-1 and/or HIV-2 in human sera.
WHO, Geneva, Reports 3-11, 1991-1999.


    

 

 

HIV testing: a practical approach    38  Page 39  40  top of page

  Appendix 2: Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2

 

APPENDIX 2 - Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2
 

ELISA tests continued
Name  VIDAS HIV-1 + 2 VIRONOSTIKA
HIV Uni-Form II
BIOTEST
Anti - HIV- 1/-2
recombinant
INNOTEST
HIV-1/HIV-2
Ab. s.p.
UBI HIV 1/2
EIA
ETI-AB-
HIV-1/2 K
Manufacturer  Bio Merieux s.a. Organon Teknika BV Biotest AG Innogenetics n.v. United Biomedical
Inc.
Sorin Biomedica 
Sensitivity 100 100 100 100 100 100
Specificity 97.8 98.8 99.1 98.8 100 98.8
Positive predictive value at prevalence of 0.01% (6%) 97.85 (98.55) 0.83 (84.18) 1.10 (87.64) 0.83 (84.18 100 (100) 0.83 (84.18)
Number of tests Per kit (smallest/biggest)  60 192/576 96/480 96/480 192/960 192
Storage conditions C 2-8C 2-8C 2-8C 2-8C 2-8C 2-8C
Incubation temperature 37C 37C  2 and  18-25C 40C and 20-25C 37C and 20-25C 37C 2C 37C and 20-25C
Reader or visual visual (fluorescent
detection)
reader  reader  reader  reader  reader 
Equipment needed not provided in the kit automated analyser
automatic pipette
refrigerator
automatic pipette
incubator
microtitreplate
multichannel
reagent trough
refrigerator
spectrophotometric
reader
washer
automatic pipette
incubator
microtitreplate
multichannel
reagent trough
refrigerator
spectrophotometric
reader
washer
automatic pipette
incubator
microtitreplate
multichannel
refrigerator
spectrophotometric
reader
washer
automatic pipette
incubator
microtitreplate
multichannel
reagent trough
refrigerator
spectrophotometric
reader
agitator/rocker
automatic pipette
incubator
refrigerator
spectrop hotometric
reader
washer
Time to perform single test for 1 serum/90 sera
(hours/minutes)
0.40/2.15 1.40/2.04 1.30/1.58 1.45/2.08 1.15/1.45 1.40/2.04
Ease of performance very easy less easy less easy less easy less easy less easy
Least and largest number of tests run at a time
(no. of controls needed per test)
1 to 30 (and 2c) 7 to 92 (and 4-5c) 10 to 90 (and 6c)    4 to 92 (and 4c) 8 to 88 (and 8c)  2 to 90 (and 6c)
Shelf life at 2 - 8 C if not stated otherwise  6-9 months 12 months 6 months 12 months 12 months 9 months
Costs per test (supply by WHO, bulk purchase prices) US$3.6 US$1.7 US$1.2 US$1.5 US$1 US$1.5
Suitability for small blood banks suitable less suitable less suitable less suitable less suitable less suitable

 

 

HIV testing: a practical approach    39  Page 40  41  top of page

  Appendix 2: Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2

 

APPENDIX 2 Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2

ELISA tests continued
Name  HIV EIA Enzygnost
Anti-HIV 1/2 Plus
I C E * HIV-1.0.2 VIRONOSTIKA
HIV Uni-Form II
plus 0
Genscreen
HIV 1/2
Manufacturer  Labsystems OY Behringwerke AG  Murex Biotech Ltd Organon Teknika BV Sanofi Diagnostique Pateur
Sensitivity 100 100 100 100 100
Specificity 99.4 99.7 99.4 100 98.5
Positive predictive value at prevalence of 0.01% (6%) 1.64 (91.41) 3.23 (95.51) 1.64 (91.41) 100 (100) 0.66 (80.97)
Number of tests Per kit (smallest/biggest)  96/960 192/960 96/480 192/576 96/480
Storage conditions C 2-8C 2-8C 2-8C 2-8C 2-8C
Incubation temperature 37C and 20-25C 37C and 20-25C 37C 37C and 18-25C 40C and 18-30C
Reader or visual reader  reader  reader  reader  reader 
Equipment needed not provided in the kit automatic pipette
incubator
refrigerator
spectrophotometric
reader
washer
automatic pipette
incubator
refrigerator
spectrophotometric
reader
washer
automatic pipette
incubator
refrigerator
spectrophotometric
reader
washer
automatic pipette
incubator
refrigerator
spectrophotometric
reader
washer
automatic pipette
incubator
refrigerator
spectrophotometric
reader
washer
Time to perform single test for 1 serum/90 sera
(hours/minutes)
1.25/1.50 1.40/2.05 2.10/2.30 1.40/2.05 1.40/2.05
Ease of performance less  easy less easy less easy less easy less easy
Least and largest number of tests run at a time
(no. of controls needed per test)
8 to 88 (and 8c) 2 to 90 (and 6c) 2  to 90 (and 6c)    3 to 91 (and 4-5c) 3 to 91 (and 5c)
Shelf life at 2 - 8 C if not stated otherwise  12 12 months 9 months 12 months 12 months
Costs per test (supply by WHO, bulk purchase prices) US$0.90 per 96
(US$0.60 per 960)
US$0.53 per 192
(US$0.43 per 960)
US$0.45 US$0.45 US$0.60 per 96
(US$0.45 per 480)
Suitability for small blood banks less suitable less suitable less suitable less suitable less suitable

 

 

HIV testing: a practical approach    40  Page 41  42  top of page

  Appendix 2: Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2

 

APPENDIX 2 Characteristics of some selected HIV tests for detection o f HIV-1 and HIV-2

Simple/rapid tests
Name  Test Pack 
HIV-l/HIV-2 Ab
HIVSPOT 1+2 Serodia - HIV -1/2  CAPILLUS
HIV-l/HIV-2
Immunocomb II Dipstick-HIV 1 + 2
Manufacturer  Abbott  Genelabs
Diaqnostics
Fujirebio Cambridge
Diaqnostics
PBS Orgenics Immuno-Chemical
Laboratories
Principle membrane test   agglutination agglutination immunodot immunodot
Sensitivity 100 100 100 100 100 100
Specificity 95.5 100 100 98.8 99.7 98.2
Positive predictive value at prevalence of 0.01% (6%) 0.4 (71.4) 100 (100) 100 (100) 0.83 (84.18 3.23 (95.51) 0.55 (78.00)
Number of tests Per kit (smallest/biggest)  40 20/100 220 20/100 36 46/96192
Storage conditions C 2-8C 2-8C 2-8C 2-8C 2-8C 2-8C
Incubation temperature 15-30C 18-25C 20-25C 18-25C 20-26C 20-28C
Reader or visual visual visual visual visual or digital reader visual or digital reader visual
Reader variability (% difference in interpretation of results by different readers) 1.4 % 7.2 % 6.3 % 0 % 4.5 % 1 %
Equipment needed not provided in the kit microtitreplate
refrigerator
refrigerator automatic pipette

microtitreplate
refrigerator

refrigerator microtitreplate
reagent trough
refrigerator
Time to perform single test for 1 serum/90 sera
(hours/minutes)
0.05/1.35 0.02/0.20 2.05/3.00 0.03/1.30 0.40/1.25 0.30/2.00
Ease of performance very easy  easy less easy very easy very easy easy
Least and largest number of tests run at a time
(no. of controls needed per test)
1 to 8 (and 2c) 1 to 12 (and 3c) 1 to 24 1 to 8 (and 2c) 1 to 10 (and 2c)  1 to 6 (and 2c)
Shelf life at 2 - 8 C if not stated otherwise  8 12 months 12 months 9 months 12 months 12 months
Costs per test (supply by WHO, bulk purchase prices) US$4.8 US$4
(US$2.30 per 100)
US$2.8 US$2.8 for 20
(US$2.2 per 100)
US$1.67 US$0.48
Suitability for small blood banks very suitable very suitable suitable very suitable very suitable very suitable



    

 

 

HIV testing: a practical approach    41  Page 42  43  top of page

  Appendix 2: Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2

 

APPENDIX 2 Characteristics o f some selected HIV tests for detection o f HIV-1 and HIV-2
 

Simple/rapid tests continued
Name  DIA 
(Dot Immuno Assay) HIV 1 + 2 
HIVCHECK
System 3 Test 3 Kit
HIV TRI-DOT BIONOR HIV-1 & 2  HIV 1 & 2
DoubleCheck
Manufacturer  Weiner Lab. Ortho Diagnostic System J. Mitra & Co. Ltd Bionor A/S
Orgenics
Principle immunodot membrane  membrane  rapid EIA chromatographic membrane 
Sensitivity 99.6 99.6 99.6 00 100
Specificity 99.4 99.7 99.7 98.8 99.4
Positive predictive value at prevalence of 0.01% (6%) 1.63 (91.34) 3.21 (95.49) 3.21 (95.49) 0.83 (84.18) 1.64 (91.41)
Number of tests Per kit (smallest/biggest)  48 100 10/20/50/100 40/200 40
Storage conditions C 2-8C 18-25C 2-8C 2-8C 2-8C
Incubation temperature 25-30C room temperature room temperature room temperature 22-26C
Reader or visual visual visual visual visual  visual
Reader variability (% difference in interpretation of results by different readers) 0.8 % 3.2 % 3.2 % 1.0 % 0.8 %
Equipment needed not provided in the kit refrigerator - refrigerator refrigerator reagent trough
Time to perform single test for 1 serum/90 sera
(hours/minutes)
0.30/2.00 0.03/0.45 0.03/3.30 0.30/3.00 0.11/4.00
Ease of performance easy  easy very easy very easy very easy
Least and largest number of tests run at a time
(no. of controls needed per test)
1 to 6 (and 2c) 1 to 8 (and 2-3c) 1 to 3 (and 2c) 1 to 37 (and 3c) 1 to 5 (and 2c) 
Shelf life at 2 - 8 C if not stated otherwise  12 months 6 months
(at 18-25C)
12 months 6 months 12 months
Costs per test (supply by WHO, bulk purchase prices) less than US$1.00 US$4.35 US$1.2 US$2.5
(not WHO)
US$1.35
Suitability for small blood banks very suitable very suitable very suitable very suitable very suitable



    

 

 
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