TY - JOUR
T1 - Diagnosis of HIV-1 infection
T2 - Performance of Xpert Qual and Geenius supplemental assays in fourth generation ELISA-reactive samples
AU - Rakovsky, Aviya
AU - Gozlan, Yael
AU - Bassal, Ravit
AU - Wax, Marina
AU - Shirazi, Rachel
AU - Bakhanashvili, Mary
AU - Kra-Oz, Zipi
AU - Radian-Sade, Sara
AU - Ben-Zvi, Haim
AU - Schreiber, Licita
AU - Wolf, Dana G.
AU - Shemer-Avni, Yonat
AU - Chemtob, Daniel
AU - Mendelson, Ella
AU - Mor, Orna
N1 - Publisher Copyright:
© 2018 Elsevier B.V.
PY - 2018/4
Y1 - 2018/4
N2 - Background: Architect (AR) and Vidas (VD) fourth generation HIV screening immunoassays, which identify early stages of HIV infections, could have false positive results especially at low signal/cutoff (S/C) AR values. Geenius HIV1/2 (GS) is a specific confirmation line immunoassay that is not highly sensitive to early HIV infections. An HIV-1 RNA assay may better detect such infections. Objectives: To evaluate all AR-VD reactive samples with GS results, and to assess Xpert Qual HIV-1 RNA assay (XQ) as an alternative to GS, in the first low S/C AR-VD-reactive samples from a tested individual. Study design: First AR-VD-reactive-GS-tested results from all individuals with resolved HIV status, collected between March 2015 and March 2017 (n = 749), were retrospectively assessed. Samples with AR-VD-reactive-GS-discordant results and those with low S/C AR-VD-reactive results, were tested by XQ. Receiver operating characteristic (ROC) analysis of GS and XQ sensitivity/specificity was performed. Results: Overall, 94.1% (705/749) of AR-VD-reactive results were true HIV-1 positive. All samples with <3 S/C AR values were false positive. XQ resolved all first samples with AR-VD-reactive-GS-discordant results. The diagnostic accuracy of XQ in low (≤33 S/C) AR-VD-reactive samples was better than that of GS (97.6%, 81/83 versus 73.5%, 61/83, p < 0.01). ROC analysis for low S/C AR samples was optimal for pooled XQ and GS results. Conclusions: Incorporating XQ in the current screening algorithm for the first AR-VD-reactive-GS-discordant samples may significantly reduce overall turn-around time of HIV-1 diagnosis.
AB - Background: Architect (AR) and Vidas (VD) fourth generation HIV screening immunoassays, which identify early stages of HIV infections, could have false positive results especially at low signal/cutoff (S/C) AR values. Geenius HIV1/2 (GS) is a specific confirmation line immunoassay that is not highly sensitive to early HIV infections. An HIV-1 RNA assay may better detect such infections. Objectives: To evaluate all AR-VD reactive samples with GS results, and to assess Xpert Qual HIV-1 RNA assay (XQ) as an alternative to GS, in the first low S/C AR-VD-reactive samples from a tested individual. Study design: First AR-VD-reactive-GS-tested results from all individuals with resolved HIV status, collected between March 2015 and March 2017 (n = 749), were retrospectively assessed. Samples with AR-VD-reactive-GS-discordant results and those with low S/C AR-VD-reactive results, were tested by XQ. Receiver operating characteristic (ROC) analysis of GS and XQ sensitivity/specificity was performed. Results: Overall, 94.1% (705/749) of AR-VD-reactive results were true HIV-1 positive. All samples with <3 S/C AR values were false positive. XQ resolved all first samples with AR-VD-reactive-GS-discordant results. The diagnostic accuracy of XQ in low (≤33 S/C) AR-VD-reactive samples was better than that of GS (97.6%, 81/83 versus 73.5%, 61/83, p < 0.01). ROC analysis for low S/C AR samples was optimal for pooled XQ and GS results. Conclusions: Incorporating XQ in the current screening algorithm for the first AR-VD-reactive-GS-discordant samples may significantly reduce overall turn-around time of HIV-1 diagnosis.
KW - Architect
KW - ELISA
KW - Geenius
KW - HIV-1 infection
KW - Vidas
KW - Xpert HIV-1 Qual
UR - http://www.scopus.com/inward/record.url?scp=85041385110&partnerID=8YFLogxK
U2 - 10.1016/j.jcv.2018.01.007
DO - 10.1016/j.jcv.2018.01.007
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C2 - 29414189
AN - SCOPUS:85041385110
SN - 1386-6532
VL - 101
SP - 7
EP - 10
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
ER -