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8/16/2019 FDA-testing Approvedmoderate Highcomplexity Hiv Laboratory
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FDA-Approved HIV tests for laboratory use only(CLIA Moderate or High Complexity Tests)a,b
[For use with: serum, plasma, oral fluid or dried blood spots]HIV Screening Tests
Test Name
Time totest
resultTarget analyte
(test generation)
Sensitivity forestablished
HIV-1 infectionand sensitivity for
HIV-2 infection
(%) (95%ConfidenceInterval)
Specificity forestablished
HIV-1 infection
(%) (95%ConfidenceInterval)
Approvedspecimen types
and volumec Assay format Man
Abbott Architect HIV Ag/AbCombo Assay
(fully automated CLIA moderateassay)
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ADVIA Centaur HIV 1/O/2
Enhanced (EHIV)
(fully automated CLIA moderateassay)
3 hours Antibodies to HIV-1
(1st generation)Plasma/serum/
dried blood spots:100 (99.6-100),oral fluid: 99.1f
Plasma/serum/dried blood spots:100 (99.9-100),oral fluid: 99.6f
Plasma/serum, DBSor oral fluid collected
with the OraSureHIV-1 oral fluid
collection device, 15μlplasma, serum, or
oral fluid; dried bloodspot ¼” punch
Enzyme-linkedimmunosorbent assay
(ELISA) e http:
q/ind
ntent
Bio-Rad GS HIV Combo Ag/Ab EIA(manual or semi-automatedCLIA high complexity assay)
>3 hours
HIV-1 p24 antigen andantibodies to HIV-1/2
(4th generation)
Plasma/serumHIV-1 p24: 100%f
HIV-1: 100 (99.7-100)HIV-2: 100 (98.1-100)
Plasma/serum99.9 (99.8-99.9)
Plasma/serum75 μl
Enzyme immunoassaymicro-well format
(EIA) e
rad.co
dg
http://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assayshttp://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assayshttp://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assayshttp://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.bio-rad.com/webroot/web/pdf/cdg/literature/P-143.pdfhttp://www.bio-rad.com/webroot/web/pdf/cdg/literature/P-143.pdfhttp://upload.wikimedia.org/wikipedia/commons/c/cf/BioTek_ELx405_Washer022310.jpghttp://www.bio-rad.com/webroot/web/pdf/cdg/literature/P-143.pdfhttp://www.bio-rad.com/webroot/web/pdf/cdg/literature/P-143.pdfhttp://www.bio-rad.com/webroot/web/pdf/cdg/literature/P-143.pdfhttp://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assayshttp://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assayshttp://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assays
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HIV Supplemental Tests
Bio-Rad GS HIV-1/2 Plus O(manual or semi-automatedCLIA high complexity assay)
>3 hours Antibodies to HIV-1/2
(3rd generation)Plasma/serum
HIV-1: 100 (99.8-100)HIV-2: 100 (99.8-100)
Plasma/serum99.9 (99.8-100)
Plasma/serum75μl
Enzymeimmunoassay micro-well
format(EIA) e
http:/rad.co
P/M4T
1/HIV
Ortho Vitros ECi/ECiQ Anti-HIV 1+2 Reagent pack
(fully automatedCLIA high complexity assay)
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Test Name
Time
totest
result
Target analyte,
Test generation
Sensitivity for
establishedHIV-1 infection
(%) (95% Confidence
Interval)
Specificity for
establishedHIV-1 infection
(%) (95% Confidence
Interval)
Specimen types
and volumec
Assay format Man
Multispot HIV-1/HIV-2 Rapid TestCLIA moderate complexity
20 min
Differentiates antibodiesto HIV-1 and HIV-2, canbe used as a screeningtest or as a supplementaltest in a diagnosticalgorithm
Serum or plasma100 (99.9-100)
Serum or plasma99.9 (99.8-100)
Serum or plasma30 μl
ImmunoConcentration
rad.co
U/2
1
Aptima HIV-1 RNA Qualitative Assay(CLIA high complexity assay)
> 3hours
HIV-1 Viral RNA(Not applicable)
Plasma/serumsensitivity at 100
copies/ml:100 (99.6-100)
Plasma/serumHIV-1 RNA: 99.8 g
Plasma/serum500 μl
Transcription-mediatedamplification of nucleic
acid
p
ser
Bio-Rad Genetic Systems HIV-1Western Blot (CLIA high complexity
assay)
>3hours
Antibodies to HIV-1(1st generation)
HIV-1 plasma/serum/driedblood spots
established HIV-1infection: 100 g
Plasma/serum/driedblood spots
HIV-1 indeterminate ratein low risk populationsthat are EIA negative:
10.7% g
Plasma/serum ordried blood spots
10μl
Western blotelectrophoresis
(WB)
rad.c
G/Cat
rovi
http://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Test
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Fluorognost HIV-1 IFA
(CLIA high complexity assay)
1.5hours
antibodies to HIV-1(1st generation)
plasma/serumestablished
HIV-1 infection: 100 g
plasma/serum99.0 g
plasma/serum10 μl
indirectimmunofluorescence
(IFA)
http:fluoronical
1ifa_
Cambridge Biotech HIV-1 Serum
Western Blot (CLIA high complexityassay)
> 3hours
Antibodies to HIV-1(1st generation)
Plasma/serumestablished
HIV-1 infection: sensitivityis not provided in the
product insertg
Plasma/serum g Plasma/serum
20 μl
Western blotelectrophoresis
(WB)
http:om/9
OraSure HIV-1 Western Blot (only usedwith specimens collected with theOraSure HIV-1 oral fluid collectiondevice) CLIA high complexity assay
> 3hours
Antibodies to HIV-1(1st generation)
Oral fluidconfirmed positive AIDS
subjects: 97.5 g confirmed high risk
persons: 99.5 g
Oral fluid99.9 g
Oral fluid150 μl
Western blotelectrophoresis
(WB)
http:/cs/pdv_1_
H
a The Clinical Laboratory Improvement Amendments (CLIA) sets criteria based on complexity levels of tests. Briefly, there are t hree levels of complexity: 1) Waived – simple, low-risk tests that can be perfo
training that do not require centrifugation of specimens for testing, 2) Moderate Complexity – simple tests that use plasma or serum specimens (must participate in external proficiency testing program) 3)
tests that require trained lab personnel, involve multiple step protocols, frequent quality control, and participation in external proficiency testing program. For more information about CLIA regulations go to
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html
b For more information about using HIV tests in multi-test algorithms see Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline (M53-A) available fo
http://www.clsi.org/source/orders/Product_Display.cfm?section=Shop&task=3&CATEGORY=MI&PRODUCT_TYPE=SALES&SKU=M53A.
c Volume for initial test. Repeat testing of reactive tests may be required based on manufacturer’s instructions.
http://www.sanochemia.de/fluorognost/references_technicalresourcesforfluorognosthiv-1ifa_top10reasonstousefluorognosthiv-1ifa.phphttp://www.sanochemia.de/fluorognost/references_technicalresourcesforfluorognosthiv-1ifa_top10reasonstousefluorognosthiv-1ifa.phphttp://www.sanochemia.de/fluorognost/references_technicalresourcesforfluorognosthiv-1ifa_top10reasonstousefluorognosthiv-1ifa.phphttp://www.sanochemia.de/fluorognost/references_technicalresourcesforfluorognosthiv-1ifa_top10reasonstousefluorognosthiv-1ifa.phphttp://www.mbidiagnostic.com/98002hivserumwb.htmlhttp://www.mbidiagnostic.com/98002hivserumwb.htmlhttp://www.orasure.com/docs/pdfs/products/orasure_hiv_1_western_blot/OraSure-HIV-1-Western-Blot-Package-Insert.pdfhttp://www.orasure.com/docs/pdfs/products/orasure_hiv_1_western_blot/OraSure-HIV-1-Western-Blot-Package-Insert.pdfhttp://www.orasure.com/docs/pdfs/products/orasure_hiv_1_western_blot/OraSure-HIV-1-Western-Blot-Package-Insert.pdfhttp://www.orasure.com/docs/pdfs/products/orasure_hiv_1_western_blot/OraSure-HIV-1-Western-Blot-Package-Insert.pdfhttp://www.orasure.com/docs/pdfs/products/orasure_hiv_1_western_blot/OraSure-HIV-1-Western-Blot-Package-Insert.pdfhttp://www.orasure.com/docs/pdfs/products/orasure_hiv_1_western_blot/OraSure-HIV-1-Western-Blot-Package-Insert.pdfhttp://www.orasure.com/docs/pdfs/products/orasure_hiv_1_western_blot/OraSure-HIV-1-Western-Blot-Package-Insert.pdfhttp://www.orasure.com/docs/pdfs/products/orasure_hiv_1_western_blot/OraSure-HIV-1-Western-Blot-Package-Insert.pdfhttp://www.orasure.com/docs/pdfs/products/orasure_hiv_1_western_blot/OraSure-HIV-1-Western-Blot-Package-Insert.pdfhttp://www.orasure.com/docs/pdfs/products/orasure_hiv_1_western_blot/OraSure-HIV-1-Western-Blot-Package-Insert.pdfhttp://www.mbidiagnostic.com/98002hivserumwb.htmlhttp://www.mbidiagnostic.com/98002hivserumwb.htmlhttp://www.sanochemia.de/fluorognost/references_technicalresourcesforfluorognosthiv-1ifa_top10reasonstousefluorognosthiv-1ifa.phphttp://www.sanochemia.de/fluorognost/references_technicalresourcesforfluorognosthiv-1ifa_top10reasonstousefluorognosthiv-1ifa.phphttp://www.sanochemia.de/fluorognost/references_technicalresourcesforfluorognosthiv-1ifa_top10reasonstousefluorognosthiv-1ifa.phphttp://www.sanochemia.de/fluorognost/references_technicalresourcesforfluorognosthiv-1ifa_top10reasonstousefluorognosthiv-1ifa.phphttp://www.sanochemia.de/fluorognost/references_technicalresourcesforfluorognosthiv-1ifa_top10reasonstousefluorognosthiv-1ifa.phphttp://www.sanochemia.de/fluorognost/references_technicalresourcesforfluorognosthiv-1ifa_top10reasonstousefluorognosthiv-1ifa.php
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d Abbott Architect HIV Ag/Ab Combo Assay’s average analytica l sensitivity for p24 Ag: 18.1 pg/ml (range 17.8-19.7).
e As antibody assays evolved with different mechanisms of detection the terminology to describe this group of tests is now commonly referred to as “Immunoassays” or “IAs”.
f Bio-Rad’s GS HIV Combo Ag/Ab EIA assay’s average analytical sensitivity for p24 Ag: 14.8 pg/ml (range 13.2-15.9)
g The 95% confidence interval was not provided in the product insert.
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