From the Department of Pathology and Laboratory Medicine, Rutgers University - Robert Wood Johnson Medical School, Somerset.
Department of Nursing, William Paterson University, Wayne.
Sex Transm Dis. 2020 May;47(5S Suppl 1):S35-S40. doi: 10.1097/OLQ.0000000000001138.
The performance of a statewide HIV rapid test algorithm (RTA) in a low-prevalence setting (0.71%) was examined for 3 years.
An initial rapid screening by HIV-1/2 Ag/Ab Combo test (RT#1) with Ab verification using a second, different rapid test (RT#2) was conducted. Clinic referral was immediate for antigen-only-positive screens. Antibody-positive screens were confirmed by RT#2. Specimens were collected following discordant RTA results (initially Ab-POS by RT#1, but negative on RT#2) and tested in accordance with the current Centers for Disease Control and Prevention/Association of Public Health Laboratories-based HIV diagnostic algorithm supplemented by a quantitative viral load whenever possible.
Of 310,785 tests performed, 2400 preliminary positive screens were identified; 2191 (91.8%) confirmed by RT#2. Of 13 Determine Combo AG-POS results identified, only 1 confirmed positive. Of the remaining 196 discordant results, 182 (92.9%) were uninfected, including 13 with AG-POS/AB-POS results. Of 14 true positives (7.1%) identified after discordant RTA results, the average quantitative HIV-1 viral load was 277,385 copies/mL, but 5 (35.7%) of 14 had viral loads <1000 copies/mL. Among the 2191 "presumptive positive" by RTA, 3 false-positive (FP) RTAs were reported (both rapid tests having positive results, while the HIV-1/2 Ag/Ab assay and quantitative HIV-1 viral load showed negative results).
The RTA was effective in predicting true-positive HIV test results and facilitating linkage to care. Discordant results were infrequent. Fingerstick DC Ag detection identified a single early infection. Many discordant cases that were subsequently positive were associated with viral loads <1000 copies/mL.
在低流行率环境（0.71%）下，对一项全州范围的 HIV 快速检测算法（RTA）进行了 3 年的性能评估。
最初使用 HIV-1/2 Ag/Ab Combo 检测（RT#1）进行快速筛查，并用第二种不同的快速检测（RT#2）对抗体进行验证。抗原阳性筛查立即转介至诊所。抗体阳性筛查采用 RT#2 进行确认。对 RTA 结果不一致的样本（最初 RT#1 为 Ab-POS，但 RT#2 为阴性）进行采集，并根据当前疾病控制与预防中心/公共卫生实验室协会的 HIV 诊断算法进行检测，如有可能，还会补充定量病毒载量检测。
在进行的 310785 次检测中，发现 2400 例初步阳性筛查；其中 2191 例（91.8%）经 RT#2 确认。在 13 例确定的 Combo AG-POS 结果中，只有 1 例确认为阳性。在其余 196 例不一致的结果中，182 例（92.9%）为未感染者，其中包括 13 例 AG-POS/AB-POS 结果。在不一致的 RTA 结果后发现的 14 例真阳性（7.1%）中，平均 HIV-1 病毒载量为 277385 拷贝/ml，但 14 例中有 5 例（35.7%）病毒载量<1000 拷贝/ml。在 RTA 确定的 2191 例“推定阳性”中，报告了 3 例假阳性（FP）RTA（两种快速检测均呈阳性结果，而 HIV-1/2 Ag/Ab 检测和定量 HIV-1 病毒载量显示阴性结果）。
RTA 能够有效预测 HIV 检测的真阳性结果，并促进与护理的衔接。不一致的结果很少见。指尖 DC Ag 检测发现了一例早期感染。许多随后呈阳性的不一致病例与病毒载量<1000 拷贝/ml 有关。
