HIV Epidemiology and Field Services Program, The New York City Department of Health and Mental Hygiene, New York, NY 11101, USA.
J Clin Virol. 2011 Dec;52 Suppl 1:S41-4. doi: 10.1016/j.jcv.2011.09.017. Epub 2011 Oct 12.
Recent improvements in the sensitivity of immunoassays (IA) used for HIV screening, coupled with increasing recognition of the importance of rapid point-of-care testing, have led to proposals to adjust the algorithm for serodiagnosis of HIV so that screening and confirmation can be performed using a dual or triple IA sequence that does not require Western blotting for confirmation. One IA that has been proposed as a second or confirmatory test is the Bio-Rad Multispot(®) Rapid HIV-1/HIV-2 Test. This test would have the added advantage of differentiating between HIV-1 and HIV-2 antibodies.
To compare the sensitivity and type-specificity of an algorithm combining a 3rd generation enzyme immunoassay (EIA) followed by a confirmatory Multispot with the conventional algorithm that combines a 3rd generation EIA (Bio-Rad GS HIV-1/HIV-2 Plus O EIA) followed by confirmatory Western blot (Bio-Rad GS HIV-1 WB).
8760 serum specimens submitted for HIV testing to the New York City Public Health Laboratory between May 22, 2007, and April 30, 2010, tested repeatedly positive on 3rd generation HIV-1-2+O EIA screening and received parallel confirmatory testing by WB and Multispot (MS).
8678/8760 (99.1%) specimens tested WB-positive; 82 (0.9%) tested WB-negative or indeterminate (IND). 8690/8760 specimens (99.2%) tested MS-positive, of which 14 (17.1%) had been classified as negative or IND by WB. Among the HIV-1 WB-positive specimens, MS classified 26 (0.29%) as HIV-2. Among the HIV-1 WB negative and IND, MS detected 12 HIV-2.
MS detected an additional 14 HIV-1 infections among WB negative or IND specimens, differentiated 26 HIV-1 WB positives as HIV-2, and detected 12 additional HIV-2 infections among WB negative/IND. A dual 3rd generation EIA algorithm incorporating MS had equivalent HIV-1 sensitivity to the 3rd generation EIA-WB algorithm and had the added advantage of detecting 12 HIV-2 specimens that were not HIV-1 WB cross-reactors. In this series an algorithm using EIA followed by MS would have resulted in the expedited referral of 38 specimens for HIV-2 testing and 40 specimens for nucleic acid confirmation. Further testing using a combined gold standard of nucleic acid detection and WB is needed to calculate specificity and validate the substitution of MS for WB in the diagnostic algorithm used by a large public health laboratory.
最近免疫分析（IA）用于 HIV 筛查的灵敏度有所提高，同时越来越认识到即时检测的重要性，这导致了对 HIV 血清学诊断算法进行调整的建议，以便使用不进行 Western blot 确认的双或三联 IA 序列进行筛查和确认。已提出的一种 IA 作为第二种或确认性检测，是 Bio-Rad Multispot（®）快速 HIV-1/HIV-2 检测。这种检测将具有区分 HIV-1 和 HIV-2 抗体的额外优势。
比较第三代酶免疫分析（EIA）后联合确认的 Multispot 与传统算法（第三代 EIA[Bio-Rad GS HIV-1/HIV-2 Plus O EIA]后联合确认 Western blot[Bio-Rad GS HIV-1 WB]）相结合的算法的灵敏度和型特异性。
2007 年 5 月 22 日至 2010 年 4 月 30 日期间，纽约市公共卫生实验室提交的 8760 份用于 HIV 检测的血清标本在第三代 HIV-1-2+O EIA 筛查中反复呈阳性，并通过 WB 和 Multispot（MS）进行平行确认检测。
8678/8760（99.1%）标本 WB 阳性；82（0.9%）标本 WB 阴性或不确定（IND）。8690/8760 标本（99.2%）MS 阳性，其中 14 份（17.1%）经 WB 分类为阴性或 IND。在 HIV-1 WB 阳性标本中，MS 将 26 份（0.29%）分类为 HIV-2。在 HIV-1 WB 阴性和 IND 中，MS 检测到 12 份 HIV-2。
MS 在 WB 阴性或 IND 标本中检测到另外 14 例 HIV-1 感染，将 26 例 HIV-1 WB 阳性标本鉴定为 HIV-2，并在 WB 阴性/IND 中检测到另外 12 例 HIV-2 感染。第三代 EIA 算法结合 MS 具有与第三代 EIA-WB 算法相当的 HIV-1 敏感性，并且具有检测 12 例未与 HIV-1 WB 发生交叉反应的 HIV-2 标本的额外优势。在该系列中，使用 EIA 后加 MS 的算法将使 38 份标本进行 HIV-2 检测和 40 份标本进行核酸确认得以加速。需要进一步使用核酸检测和 WB 的联合金标准进行检测，以计算特异性并验证 MS 在大型公共卫生实验室使用的诊断算法中替代 WB 的情况。
