BACKGROUND A new point-of-care (POC) HIV virus load technology has been recently developed and designed to be utilized in decentralized settings. Alere Technologies GmbH*, Germany, developed the mPIMA HIV-1/2 VL plasma test which uses real time PCR technology with 50 μl and a turnaround time of one hour. OBJECTIVE Analyze the performance of mPIMA to detect and quantify HIV-1 and HIV-2 and compare with Abbott M2000 assay fooling patients HIV-1 failing ARV therapy. STUDY DESIGN In this study we evaluate the mPIMA HIV-1/2 VL plasma test using 413 specimens from 270 patients failing ARV therapy, and compared its performance with Abbott RealTime HIV-1 Viral Load assay on the m2000 system. In addition, were determined VL in plasma specimens obtained from HIV-2 infected patients. RESULTS The results strongly indicate that mPIMA HIV-1/2 VL plasma test can determine HIV-1 with concordance of 88.9 % (95 % CI 85.4-91.7) the reference test when 1000 HIV-1 VL threshold was used as WHO cutoff to identify therapy failure. The overall correlation between HIV-1 VL was 0928 (Pearson correlation coefficient of Linear regression) and the Bland-Altman showed a mean difference of -0.20 Log cp/mL between the two technology. mPIMA HIV-1/2 VL plasma test was also able to measure HIV-2 viral load in 16 specimens from Guinea-Bissau HIV-1/HIV-2 positive samples. CONCLUSIONS These data support the use of mPIMA HIV-1/2 VL plasma test to follow up patients and select patients failing ART, guiding immediate clinical decisions such as adherence counseling or ART regimen switch during the patient consultation.

中文翻译：

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新型即时医疗点HIV病毒装载技术的性能，可识别抗逆转录病毒治疗失败的患者。

背景技术最近已经开发并设计了一种新的即时医疗点（POC）HIV病毒装载技术，以用于分散环境。德国Alere Technologies GmbH *开发了mPIMA HIV-1 / 2 VL血浆测试，该测试使用50μl实时PCR技术，周转时间为一小时。目的分析mPIMA检测和定量检测HIV-1和HIV-2的性能，并与Abbott M2000检测法相比较，以欺骗HIV-1抗逆转录病毒治疗失败的患者。研究设计在本研究中，我们使用270例ARV治疗失败的患者的413个标本评估了mPIMA HIV-1 / 2 VL血浆测试，并将其性能与m2000系统上的Abbott RealTime HIV-1病毒载量测定法进行了比较。另外，测定了从HIV-2感染患者获得的血浆标本中的VL。结果结果强烈表明，当将1000 HIV-1 VL阈值用作WHO临界值进行鉴定时，mPIMA HIV-1 / 2 VL血浆试验可以确定HIV-1的参考试验的一致性为88.9％（95％CI 85.4-91.7）治疗失败。HIV-1 VL之间的总体相关性为0928（线性回归的Pearson相关系数），而Bland-Altman显示这两种技术之间的平均差异为-0.20 Log cp / mL。mPIMA HIV-1 / 2 VL血浆测试还能够测量来自几内亚比绍HIV-1 / HIV-2阳性样本的16个样本中的HIV-2病毒载量。结论这些数据支持使用mPIMA HIV-1 / 2 VL血浆测试随访患者并选择ART失败的患者，指导即时临床决策，例如在患者咨询期间进行依从性咨询或ART方案转换。