Differential Performance of CoronaCHEK SARS-CoV-2 Lateral Flow Antibody Assay by Geographic Origin of Samples.
Differential Performance of CoronaCHEK SARS-CoV-2 Lateral Flow Antibody Assay by Geographic Origin of Samples.
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CoronaCHEK SARS-CoV-2 横向流动抗体检测的不同性能因样品的地理来源而异。
DOI：
10.1101/2021.04.12.21255284
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发表时间：
2021
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我们对来自乌干达和巴尔的摩的样本进行了CoronaCHEK侧流检测的性能评估，以确定地理来源对检测性能的影响。对严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）PCR阳性个体（乌干达，78例患者的78份样本，巴尔的摩，38例患者的266份样本）和大流行前个体（乌干达，1,077例，巴尔的摩，532例）的血浆样本进行了评价。计算患病率（PR）以确定与假阳性试验相关的因素。在乌干达样本中首次PCR阳性后，0至7天的灵敏度为45%（95%置信区间[CI]，24，68），8至14天为79%（95% CI，64至91），>15天为76%（95% CI，50至93）。在来自巴尔的摩的样本中，阳性PCR后0至7天的灵敏度为39%（95% CI，30至49），8至14天的灵敏度为86%（95% CI，79至92），15天的灵敏度为100%（95% CI，89至100）。乌干达样本的特异性为96.5%（95%CI，97.5 ~ 95.2），显著低于巴尔的摩样本的99.3%（95%CI，98.1 ~ 99.8;P< 0.01）。在乌干达样本中，假阳性结果的个体更可能是男性（PR，2.04; 95%CI，1.03，3.69）或在样本采集前发烧超过一个月的个体（PR，2.87; 95%CI，1.12至7.35）。CoronaCHEK的灵敏度在来自乌干达和巴尔的摩的样品中相似。乌干达样本的特异性显著低于巴尔的摩样本。乌干达样本中的假阳性结果似乎与近期的发热性疾病史相关，这可能表明东非个体存在交叉反应性免疫应答。
We assessed the performance of the CoronaCHEK lateral flow assay on samples from Uganda and Baltimore to determine the impact of geographic origin on assay performance. Plasma samples from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) PCR-positive individuals (Uganda, 78 samples from 78 individuals, and Baltimore, 266 samples from 38 individuals) and from prepandemic individuals (Uganda, 1,077, and Baltimore, 532) were evaluated. Prevalence ratios (PR) were calculated to identify factors associated with a false-positive test. After the first positive PCR in Ugandan samples, the sensitivity was 45% (95% confidence interval [CI], 24,68) at 0 to 7 days, 79% (95% CI, 64 to 91) at 8 to 14 days, and 76% (95% CI, 50 to 93) at >15 days. In samples from Baltimore, sensitivity was 39% (95% CI, 30 to 49) at 0 to 7 days, 86% (95% CI, 79 to 92) at 8 to 14 days, and 100% (95% CI, 89 to 100) at 15 days after positive PCR. The specificity of 96.5% (95% CI, 97.5 to 95.2) in Ugandan samples was significantly lower than that in samples from Baltimore, 99.3% (95% CI, 98.1 to 99.8;P< 0.01). In Ugandan samples, individuals with a false-positive result were more likely to be male (PR, 2.04; 95% CI, 1.03,3.69) or individuals who had had a fever more than a month prior to sample acquisition (PR, 2.87; 95% CI, 1.12 to 7.35). Sensitivity of the CoronaCHEK was similar in samples from Uganda and Baltimore. The specificity was significantly lower in Ugandan samples than in Baltimore samples. False-positive results in Ugandan samples appear to correlate with a recent history of a febrile illness, potentially indicative of a cross-reactive immune response in individuals from East Africa.