BioRad BioPlex® HIV Ag-Ab assay : Incidence of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm
Copyright © 2019 Elsevier B.V. All rights reserved..
BACKGROUND: The BioPlex® HIV Ag-Ab assay, unlike other HIV 1/2 antigen/antibody immunoassays, is capable of differentiating positive HIV-1 antibodies (Groups M and O) from HIV-2 antibodies and/or HIV-1 p24 antigen in a single test.
OBJECTIVE: The Alaska State Virology Laboratory (ASVL) adopted the BioPlex® HIV Ag-Ab assay early 2017 and can report on its performance in terms of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm recommended by the Centers for Disease Control and Prevention (CDC).
STUDY DESIGN: Specimens received between March 2017 and August 2018 were screened using the BioPlex® HIV Ag-Ab assay. Specimens screening positive for HIV antibodies or antigen were further confirmed using the Geenius™ HIV 1/2 Supplemental Assay and/or HIV RNA testing.
RESULTS: Of the 12,338 sera screened by the BioPlex assay for HIV, 35 specimens were positive. Only 22 of the specimens were confirmed by supplemental testing and were considered to be truly positive (PPV, 62.9%). RNA was not detected in these cases suggesting initial false positivity on the BioPlex® HIV Ag-Ab assay. True positive results had index values (IDX) of >180 whereas false positive IDX's were between 1 and 4, with the exception of one specimen.
CONCLUSIONS: We suggest that specimens demonstrating positivity with low IDX values <4 on the BioPlex® HIV Ag-Ab assay proceed directly to RNA testing, essentially bypassing supplemental antibody confirmation tests, to reduce turnaround time and cost of HIV confirmation.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2019 |
|---|---|
| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:116 |
|---|---|
| Enthalten in: |
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology - 116(2019) vom: 01. Juli, Seite 1-3 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Parker, Jayme [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 18.06.2020 Date Revised 01.07.2020 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.jcv.2019.04.002 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM29602001X |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM29602001X | ||
| 003 | DE-627 | ||
| 005 | 20231225084928.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2019 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.jcv.2019.04.002 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n0986.xml |
| 035 | |a (DE-627)NLM29602001X | ||
| 035 | |a (NLM)30981082 | ||
| 035 | |a (PII)S1386-6532(19)30076-9 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Parker, Jayme |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a BioRad BioPlex® HIV Ag-Ab assay |b Incidence of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm |
| 264 | 1 | |c 2019 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 18.06.2020 | ||
| 500 | |a Date Revised 01.07.2020 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2019 Elsevier B.V. All rights reserved. | ||
| 520 | |a BACKGROUND: The BioPlex® HIV Ag-Ab assay, unlike other HIV 1/2 antigen/antibody immunoassays, is capable of differentiating positive HIV-1 antibodies (Groups M and O) from HIV-2 antibodies and/or HIV-1 p24 antigen in a single test | ||
| 520 | |a OBJECTIVE: The Alaska State Virology Laboratory (ASVL) adopted the BioPlex® HIV Ag-Ab assay early 2017 and can report on its performance in terms of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm recommended by the Centers for Disease Control and Prevention (CDC) | ||
| 520 | |a STUDY DESIGN: Specimens received between March 2017 and August 2018 were screened using the BioPlex® HIV Ag-Ab assay. Specimens screening positive for HIV antibodies or antigen were further confirmed using the Geenius™ HIV 1/2 Supplemental Assay and/or HIV RNA testing | ||
| 520 | |a RESULTS: Of the 12,338 sera screened by the BioPlex assay for HIV, 35 specimens were positive. Only 22 of the specimens were confirmed by supplemental testing and were considered to be truly positive (PPV, 62.9%). RNA was not detected in these cases suggesting initial false positivity on the BioPlex® HIV Ag-Ab assay. True positive results had index values (IDX) of >180 whereas false positive IDX's were between 1 and 4, with the exception of one specimen | ||
| 520 | |a CONCLUSIONS: We suggest that specimens demonstrating positivity with low IDX values <4 on the BioPlex® HIV Ag-Ab assay proceed directly to RNA testing, essentially bypassing supplemental antibody confirmation tests, to reduce turnaround time and cost of HIV confirmation | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a BioPlex® | |
| 650 | 4 | |a False positive | |
| 650 | 4 | |a HIV | |
| 650 | 4 | |a Low-prevalence | |
| 650 | 4 | |a Positive predictive value | |
| 650 | 4 | |a Testing algorithms | |
| 650 | 7 | |a HIV Antibodies |2 NLM | |
| 650 | 7 | |a HIV Core Protein p24 |2 NLM | |
| 700 | 1 | |a Carrasco, Ana Fiorella |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Jack |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology |d 1997 |g 116(2019) vom: 01. Juli, Seite 1-3 |w (DE-627)NLM097223964 |x 1873-5967 |7 nnns |
| 773 | 1 | 8 | |g volume:116 |g year:2019 |g day:01 |g month:07 |g pages:1-3 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.jcv.2019.04.002 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 116 |j 2019 |b 01 |c 07 |h 1-3 | ||