Kusagawa Shigeru, Hamaguchi Isao, Tatsumi Masashi
AIDS Research Center, National Institute of Infectious Diseases, United States.
Research Center for Biological Products in the Next Generation, National Institute of Infectious Diseases, United States.
Pract Lab Med. 2022 Sep 26;32:e00301. doi: 10.1016/j.plabm.2022.e00301. eCollection 2022 Nov.
We established a human immunodeficiency virus type 1 (HIV-1) antigen (Ag) panel from culture supernatants of 27 HIV-1 isolates, including 11 HIV-1 subtypes, circulating recombinant forms (CRFs), and groups (HIV-1 types), to evaluate the HIV-1 Ag detection sensitivity and HIV-1 type specificity of three HIV-1 Ag/antibody (Ab) combination tests approved in Japan. The HIV-1 copy numbers were quantified by the reverse transcription quantitative polymerase chain reaction (RT-qPCR) method. They were diluted to four different copy numbers and used in this evaluation. Enzygnost HIV Integral IV gave HIV-positive results in nearly all samples, with the single exception being an HIV-negative result in a case with a value just below the cut-off in a CRF08_BC member (100,000 copies/mL). Genscreen HIV Ag-Ab ULT showed low sensitivity to HIV-1 group O members, but this is not an urgent problem as no HIV-1 group O infection cases have been reported in Japan. The detection sensitivity of Determine HIV Early Detect was lower than that of the aforementioned two tests by ten-to hundred-fold, indicating that the kit may have limited performance in the acute phase of HIV-1 infection. Our HIV-1 Ag panel is useful for evaluating the HIV-1 Ag sensitivity of HIV-1 Ag/Ab combination tests.
我们从27株人类免疫缺陷病毒1型（HIV-1）分离株的培养上清液中建立了一个HIV-1抗原（Ag）组，这些分离株包括11种HIV-1亚型、循环重组型（CRF）和组（HIV-1型），以评估日本批准的三种HIV-1抗原/抗体（Ab）联合检测的HIV-1 Ag检测灵敏度和HIV-1型特异性。通过逆转录定量聚合酶链反应（RT-qPCR）方法对HIV-1拷贝数进行定量。将它们稀释至四个不同的拷贝数并用于本评估。Enzygnost HIV Integral IV在几乎所有样本中均给出HIV阳性结果，唯一例外是在一例CRF08_BC成员中值略低于临界值（100,000拷贝/mL）的样本中出现HIV阴性结果。Genscreen HIV Ag-Ab ULT对HIV-1 O组成员显示出低灵敏度，但由于日本尚未报告HIV-1 O组感染病例，这并非紧迫问题。Determine HIV Early Detect的检测灵敏度比上述两种检测低10至100倍，表明该试剂盒在HIV-1感染急性期的性能可能有限。我们的HIV-1 Ag组可用于评估HIV-1 Ag/Ab联合检测的HIV-1 Ag灵敏度。
