Multiplex assays for malaria antigen detection can gather data from large sample sets, but considerations for the consistency and quality assurance (QA) of mass testing lack evaluation. We present a QA framework for a study occurring November 2019 to March 2020 involving 504 assay plates detecting four Plasmodium antigens: pan-Plasmodium aldolase and lactate dehydrogenase (LDH), histidine-rich protein 2 (HRP2), P. vivax LDH (PvLDH). Controls on each plate included buffer blank, antigen negative blood, and 4-point positive dilution curve. The blank and negative blood provided consistently low signal for all targets except for pAldolase, which showed variability. Positive curve signals decreased throughout the 5-month study duration but retained a coefficient of variation (CV) of < 5%, with the exception of HRP2 in month 5 (CV of 11%). Regression fittings for inter-plate control signals provided mean and standard deviations (SDs), and of 504 assay plates, 6 (1.2%) violated the acceptable deviation limits and were repeated. For the 40,272 human blood samples assayed in this study, of 161,088 potential data points (each sample × 4 antigens), 160,641 (99.7%) successfully passed quality checks. The QA framework presented here can be utilized to ensure quality of laboratory antigen detection for large sample sets.

用于疟疾抗原检测的多重检测可以从大样本集中收集数据，但对大规模检测的一致性和质量保证 (QA) 的考虑缺乏评估。我们为 2019 年 11 月至 2020 年 3 月进行的一项研究提供了一个 QA 框架，该研究涉及 504 个检测板，检测四种疟原虫抗原：泛疟原虫醛缩酶和乳酸脱氢酶 (LDH)、富含组氨酸的蛋白 2 (HRP2)、间日疟原虫LDH (PvLDH)。每个板上的对照包括缓冲空白、抗原阴性血液和 4 点阳性稀释曲线。除 pAldolase 外，空白和阴性血液为所有靶标提供了始终如一的低信号，后者显示出变异性。在 5 个月的研究期间，阳性曲线信号下降，但变异系数 (CV) 保持 < 5%，但第 5 个月的 HRP2 除外（CV 为 11%）。板间控制信号的回归拟合提供了平均值和标准偏差 (SD)，在 504 个测定板中，6 个 (1.2%) 违反了可接受的偏差限制并被重复。对于本研究中检测的 40,272 份人体血液样本，在 161,088 个潜在数据点（每个样本 × 4 个抗原）中，有 160,641 个（99.7%）成功通过了质量检查。