Details

Autor(en) / Beteiligte

• Rakovsky, Aviya
• Gozlan, Yael
• Bassal, Ravit
• Wax, Marina
• Shirazi, Rachel
• Bakhanashvili, Mary
• Kra-Oz, Zipi
• Radian-Sade, Sara
• Ben-Zvi, Haim
• Schreiber, Licita
• Wolf, Dana G.
• Shemer-Avni, Yonat
• Chemtob, Daniel
• Mendelson, Ella
• Mor, Orna

Titel

Diagnosis of HIV-1 infection: Performance of Xpert Qual and Geenius supplemental assays in fourth generation ELISA-reactive samples

Ist Teil von

• Journal of clinical virology, 2018-04, Vol.101, p.7-10

Ort / Verlag

Netherlands: Elsevier B.V

Erscheinungsjahr

2018

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• •Xpert Qual (XQ) and Geenius (GN) were assessed in Architect- (AR) Vidas (VD)-reactive samples.•XQ resolved all AR-VD-reactive-GN-discordant results and was superior to GN in low AR-VD samples.•Xpert Qual with Geenius correctly diagnose HIV in all reactive samples. 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. 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. 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. 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. 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.