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Evaluation of Serological SARS-CoV-2 Lateral Flow Assays for Rapid Point-of-Care Testing.

ABSTRACT: Rapid point-of-care tests (POCTs) for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific antibodies vary in performance. A critical need exists to perform head-to-head comparisons of these assays. The performances of 15 different lateral flow POCTs for the detection of SARS-CoV-2-specific antibodies were compared on a well-characterized set of 100 samples. Of these, 40 samples from known SARS-CoV-2-infected, convalescent individuals (collected an average of 45 days after symptom onset) were used to assess sensitivity. Sixty samples from the prepandemic era (negative control) that were known to represent infections with other respiratory viruses (rhinoviruses A, B, and C and/or coronavirus 229E, HKU1, and NL63 OC43) were used to assess specificity. The timing of seroconversion was assessed using five lateral flow assays (LFAs) and a panel of 272 longitudinal samples from 47 patients for whom the time since symptom onset was known. Among the assays that were evaluated, the sensitivity and specificity for any reactive band ranged from 55% to 97% and from 78% to 100%, respectively. Assessing the performance of the IgM and the IgG bands alone, sensitivity and specificity ranged from 0% to 88% and 80% to 100% for IgM and from 25% to 95% and 90% to 100% for IgG, respectively. Longitudinal testing revealed that the median times after symptom onset to a positive result were 7 days (interquartile range [IQR], 5.4 to 9.8) for IgM and 8.2 days (IQR, 6.3 to 11.3) for IgG. The testing performances differed widely among LFAs, with greatest amount of variation related to the sensitivity of the assays. The IgM band was the band most likely to misclassify prepandemic samples. The appearances of IgM and IgG bands occurred almost simultaneously.

SUBMITTER: Conklin SE

PROVIDER: S-EPMC8111122 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveThere is a lack of evidence addressing several important human factors questions pertaining to the quality of supportive information provided by commercial manufacturers that can affect the adoption and use of lateral flow serology assays in practice. We aimed to: (1) identify and assess the quality of information that commercial manufacturers provided for their point-of-care tests (POCTs) and (2) examine the implications of these findings on real-world settings.DesignWe used a content analysis methodology in two stages to systematically, code and analyse textual data from documents of commercial manufacturers. A deductive approach was applied using a coding guide based on the validated Point-of-Care Key Evidence Tool (POCKET) multidimensional checklist. An inductive approach was used to identify new patterns or themes generated from our textual analysis.SettingPublicly available supportive information documents by commercial manufacturers for lateral flow serology, were identified and gathered from online searches.ParticipantsSupportive information documents retrieved from online searches over 3 months (March 2020 to June 2020).ResultsA total of 79 POCTs were identified that met the study inclusion criteria. Using the POCKET coding guide, we found that the quality of information varied significantly between the manufacturers and was often lacking in detail. Our inductive approach further examined these topics and found that several statements were vague and that significant variations in the level of details existed between manufacturers.ConclusionsThis study revealed significant concerns surrounding the supportive information reported by manufacturers for lateral flow serology assays. Information transparency was poor and human factor issues were not properly addressed to mitigate the risk of improper device use, although it should be noted that the results of our study are limited by the data that manufactures were prepared to disclose. Overall, commercial manufacturers should improve the quality and value of information presented in their supporting documentation.

Dataset Information

Evaluation of Serological SARS-CoV-2 Lateral Flow Assays for Rapid Point-of-Care Testing.

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