Performance of a Point of Care Test for Detecting IgM and IgG Antibodies Against SARS-CoV-2 and Seroprevalence in Blood Donors and Health Care Workers in Panama
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Abstract
Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiologic agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic, which has reached 28 million cases worldwide in 1 year. The serological detection of antibodies against the virus will play a pivotal role in complementing molecular tests to improve diagnostic accuracy, contact tracing, vaccine efficacy testing, and seroprevalence surveillance. Here, we aimed first to evaluate a lateral flow assay's ability to identify specific IgM and IgG antibodies against SARS-CoV-2 and second, to report the seroprevalence estimates of these antibodies among health care workers and healthy volunteer blood donors in Panama. We recruited study participants between April 30th and July 7th, 2020. For the test validation and performance evaluation, we analyzed serum samples from participants with clinical symptoms and confirmed positive RT-PCR for SARS-CoV-2, and a set of pre-pandemic serum samples. We used two by two table analysis to determine the test positive and negative percentage agreement as well as the Kappa agreement value with a 95% confidence interval. Then, we used the lateral flow assay to determine seroprevalence among serum samples from COVID-19 patients, potentially exposed health care workers, and healthy volunteer donors. Our results show this assay reached a positive percent agreement of 97.2% (95% CI 84.2–100.0%) for detecting both IgM and IgG. The assay showed a Kappa of 0.898 (95%CI 0.811–0.985) and 0.918 (95% CI 0.839–0.997) for IgM and IgG, respectively. The evaluation of serum samples from hospitalized COVID-19 patients indicates a correlation between test sensitivity and the number of days since symptom onset; the highest positive percent agreement [87% (95% CI 67.0–96.3%)] was observed at ≥15 days post-symptom onset (PSO). We found an overall antibody seroprevalence of 11.6% (95% CI 8.5–15.8%) among both health care workers and healthy blood donors. Our findings suggest this lateral flow assay could contribute significantly to implementing seroprevalence testing in locations with active community transmission of SARS-CoV-2.
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SciScore for 10.1101/2020.09.25.20201459: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The inclusion criteria were being an adult over 18 years old and providing written informed consent.
IRB: This study was registered with the Panama Ministry of Health (No. 1462) and was approved by the National Research Bioethics Committee (CNBI; No. EC-CNBI-2020-03-43).Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources The qualitative test (referred to as CAST – Chinese Academy of Science Test, from this point) detects and is capable of differentiating between specific IgM and IgG antibodies against SARS-CoV-2. SARS-CoV-2suggested: NoneIgM and … SciScore for 10.1101/2020.09.25.20201459: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The inclusion criteria were being an adult over 18 years old and providing written informed consent.
IRB: This study was registered with the Panama Ministry of Health (No. 1462) and was approved by the National Research Bioethics Committee (CNBI; No. EC-CNBI-2020-03-43).Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources The qualitative test (referred to as CAST – Chinese Academy of Science Test, from this point) detects and is capable of differentiating between specific IgM and IgG antibodies against SARS-CoV-2. SARS-CoV-2suggested: NoneIgM and IgG antibody detection by LFIA: We followed a step-wise protocol for conducting the CAST. IgMsuggested: NoneIgGsuggested: NoneThe presence of one red lines indicates the sample is positive for specific IgM or IgG anti SARS-VoV-2 antibodies, while the presence of two lines indicates the sample is positive for both IgM and IgG antibodies. anti SARS-VoV-2suggested: NoneSoftware and Algorithms Sentences Resources IgM and IgG antibody detection by LFIA: We followed a step-wise protocol for conducting the CAST. CASTsuggested: (CAST, RRID:SCR_000628)Statistical analysis: Data were analyzed with SPSS version 25.0 (Armonk, SPSSsuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Our study has several limitations. First, we were not able to use samples from individuals with other respiratory tract infections to rule out cross reactivity with human coronaviruses causing common seasonal colds. However, a set of 55 pre-pandemic samples was used to validate the test, and all but one tested negative for anti-SARS-CoV-2 antibodies. Second, this rapid test is based on a colorimetric evaluation of the IgG and IgM bands determined by an operator, which implies the limitations that a qualitative inter-intra-operator evaluation might produce in terms of variability. In our study, this limitation was addressed by resorting to double operator evaluation and taking photographs of all test results to be re-analyzed by a third party in the case of first level evaluation disagreement. Third, the CAST is a qualitative detection method; thus, the antibody levels in COVID-19 patients were not measured in this study. Also, the sample size was calculated for the minimum sample required to validate the test. It is yet to be determined if the CAST produces the same results in a point-of-care setting using fresh blood samples since we used serum after centrifugation. Moreover, we have not evaluated if the CAST produces comparative results with ELISA or immunochemiluminescent tests. Ongoing work by our research team will allow us to establish the CAST’s limits of detection by comparing results with an ELISA test. The CAST (rapid test) has some advantages compared to other more...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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SciScore for 10.1101/2020.09.25.20201459: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement The inclusion criteria were being an adult over 18 years old and providing written informed consent. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Second, we conducted a field evaluation of the LFIA test to determine the seroprevalence of antiSARS-CoV-2 antibodies among healthy blood donors (HD) and health care workers (HCW). antiSARS-CoV-2suggested: NoneThe CAST manufacturer’s calculated analytical sensitivity and specificity for … SciScore for 10.1101/2020.09.25.20201459: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement The inclusion criteria were being an adult over 18 years old and providing written informed consent. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Second, we conducted a field evaluation of the LFIA test to determine the seroprevalence of antiSARS-CoV-2 antibodies among healthy blood donors (HD) and health care workers (HCW). antiSARS-CoV-2suggested: NoneThe CAST manufacturer’s calculated analytical sensitivity and specificity for both IgM and IgG anti-SARS-CoV-2 antibodies at development were 87.01% and 98.89%, respectively. anti-SARS-CoV-2suggested: (Abcam Cat# ab272854, RRID:AB_2847844)IgM and IgG antibody detection by LFIA: We followed a step-wise protocol for conducting the CAST. IgMsuggested: NoneIgGsuggested: NoneSoftware and Algorithms Sentences Resources IgM and IgG antibody detection by LFIA: We followed a step-wise protocol for conducting the CAST. CASTsuggested: (CAST, RRID:SCR_000628)Statistical analysis: Data were analyzed with SPSS version 25.0 (Armonk, NY: IBM Corp.). SPSSsuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).
Results from JetFighter: We did not find any issues relating to colormaps.
About SciScore
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