Division of Pediatric Infectious Diseases, Department of Pediatrics, Montreal Children's Hospital, Montreal, Canada.
Division of Microbiology, Department of Clinical Laboratory Medicine, Optilab Montreal-McGill University Health Centre, Montreal, Canada.
JAMA Netw Open. 2022 May 2;5(5):e2210559. doi: 10.1001/jamanetworkopen.2022.10559.
Longitudinal mass testing using rapid antigen detection tests (RADT) for serial screening of asymptomatic persons has been proposed for preventing SARS-CoV-2 community transmission. The feasibility of this strategy relies on accurate self-testing.
To quantify the adequacy of serial self-performed SARS-CoV-2 RADT testing in the workplace, in terms of the frequency of correct execution of procedural steps and accurate interpretation of the range of possible RADT results.
DESIGN, SETTING, AND PARTICIPANTS: This prospective repeated cross-sectional study was performed from July to October 2021 at businesses with at least 2 active cases of SARS-CoV-2 infection in Montreal, Canada. Participants included untrained persons in their workplace, not meeting Public Health quarantine criteria (ie, required quarantine for 10 days after a moderate-risk contact with someone infected with SARS-CoV-2). Interpretation and performance were compared between participants who received instructions provided by the manufacturer vs those who received modified instructions that were informed by the most frequent or most critical errors we observed. Data were analyzed from October to November 2021.
RADT testing using a modified quick reference guide compared with the original manufacturer's instructions.
The main outcome was the difference in correctly interpreted RADT results. Secondary outcomes included difference in proportions of correctly performed procedural steps. Additional analyses, assessed among participants with 2 self-testing visits, compared the second self-test visit with the first self-test visit using the same measures.
Overall, 1892 tests were performed among 647 participants, of whom 278 participants (median [IQR] age, 43 [31-55] years; 156 [56.1%] men) had at least 1 self-testing visit. For self-test visit 1, significantly better accuracy in test interpretation was observed among participants using the modified quick reference guide than those using the manufacturer's instructions for reading results that were weak positive (64 of 115 participants [55.6%] vs 20 of 163 participants [12.3%]; difference, 43.3 [95% CI, 33.0-53.8] percentage points), positive (103 of 115 participants [89.6%] vs 84 of 163 participants [51.5%]; difference, 38.1 [95% CI, 28.5-47.5] percentage points), strong positive (219 of 229 participants [95.6%] vs 274 of 326 participants [84.0%]; difference, 11.6 [95% CI, 6.8-16.3] percentage points), and invalid (200 of 229 participants [87.3%] vs 252 of 326 participants [77.3%]; difference, 10.0 [95% CI, 3.8-16.3] percentage points). Use of the modified guide was associated with improvements on self-test visit 2 for results that were weak positive (difference, 15.4 [95% CI, 0.7-30.1] percentage points), positive (difference, 19.0 [95% CI, 7.2-30.9] percentage points), and invalid (difference, 8.0 [95% CI, 0.8-15.4] percentage points). For procedural steps identified as critical for test validity, adherence to procedural testing steps did not differ meaningfully according to instructions provided or reader experience.
In this cross-sectional study of self-performed SARS-CoV-2 RADT in an intended-use setting, a modified quick reference guide was associated with significantly improved accuracy in RADT interpretations.
为了防止 SARS-CoV-2 在社区传播,有人提议使用快速抗原检测(RADT)对无症状人群进行纵向大规模检测,以进行连续筛查。 该策略的可行性依赖于准确的自我检测。
从程序步骤执行的频率和准确解释 RADT 结果的可能范围的角度,确定在工作场所中连续进行自我执行 SARS-CoV-2 RADT 检测的充分性。
设计、地点和参与者: 这是一项在加拿大蒙特利尔市有至少 2 例 SARS-CoV-2 感染活跃病例的企业中进行的 2021 年 7 月至 10 月的前瞻性重复横断面研究。参与者包括未接受培训的在职人员,他们不符合公共卫生检疫标准(即与 SARS-CoV-2 感染者中度风险接触后需要隔离 10 天)。比较了参与者在使用制造商提供的说明与使用根据我们观察到的最常见或最关键错误制定的修改说明之间的解释和性能。数据于 2021 年 10 月至 11 月进行分析。
使用修改后的快速参考指南与原始制造商的说明进行 RADT 检测。
主要结果是正确解释 RADT 结果的差异。次要结果包括正确执行程序步骤的比例差异。在有 2 次自我检测访问的参与者中进行了额外的分析,使用相同的测量方法比较了第二次自我检测访问与第一次自我检测访问。
在总共 1892 次测试中,有 647 名参与者进行了测试,其中 278 名参与者(中位数[IQR]年龄,43 [31-55] 岁;156 [56.1%] 为男性)至少有 1 次自我检测访问。对于第 1 次自我检测访问,与使用制造商说明进行结果解读相比,使用修改后的快速参考指南的参与者在检测结果呈弱阳性、阳性、强阳性和无效时的准确性显著提高(弱阳性结果,115 名参与者中有 64 名[55.6%],163 名参与者中有 20 名[12.3%];差异,43.3 [95% CI,33.0-53.8] 个百分点;阳性结果,115 名参与者中有 103 名[89.6%],163 名参与者中有 84 名[51.5%];差异,38.1 [95% CI,28.5-47.5] 个百分点;强阳性结果,229 名参与者中有 219 名[95.6%],326 名参与者中有 274 名[84.0%];差异,11.6 [95% CI,6.8-16.3] 个百分点;无效结果,229 名参与者中有 200 名[87.3%],326 名参与者中有 252 名[77.3%];差异,10.0 [95% CI,3.8-16.3] 个百分点)。对于弱阳性(差异,15.4 [95% CI,0.7-30.1] 个百分点)、阳性(差异,19.0 [95% CI,7.2-30.9] 个百分点)和无效(差异,8.0 [95% CI,0.8-15.4] 个百分点)结果,使用修改后的指南与第二次自我检测访问时的结果有显著改善。对于确定为测试有效性关键的程序步骤,根据提供的说明或读者经验,对测试步骤的遵守情况并没有明显差异。
在这项针对 SARS-CoV-2 RADT 在预期用途环境中的自我检测的横断面研究中,修改后的快速参考指南与 RADT 解释准确性的显著提高相关。