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      Application and Interpretation of Antibody-based Rapid Test Kits in the Context of Laboratory Diagnosis of COVID-19

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          A bstract

          Rapid kits, which are known as point-of-care (POC) tests, are extremely helpful in the diagnosis of infectious diseases, especially in remote rural areas as well as in physicians’ clinics. Since the results are available within 30 minutes, appropriate treatment can be initiated without delay and thus avoiding any complications/mortality. However, in the present scenario of COVID-19 pandemic, the need for adequate validation of the antibody-based rapid kits as an emergency is a challenge. The test results of these kits are to be interpreted with sufficient caution and proper clinical correlation. Track records of the kit manufacturers need proper scrutiny before taking a decision to use a particular test kit.

          How to cite this article: Stephen S, Pradeep J. Application and Interpretation of Antibody-based Rapid Test Kits in the Context of Laboratory Diagnosis of COVID-19. J Basic Clin Appl Health Sci 2020;3(3):104–106.

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          Interpreting Diagnostic Tests for SARS-CoV-2

          Nandini Sethuraman, Sundararaj Jeremiah, Akihide Ryo (2020)
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            Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients

            Yunbao Pan, Xinran Li, Gui Yang … (2020)
            An outbreak of new coronavirus SARS-CoV-2 was occurred in Wuhan, China and rapidly spread to other cities and nations. The standard diagnostic approach that widely adopted in the clinic is nucleic acid detection by real-time RT-PCR. However, the false-negative rate of the technique is unneglectable and serological methods are urgently warranted. Here, we presented the colloidal gold-based immunochromatographic (ICG) strip targeting viral IgM or IgG antibody and compared it with real-time RT-PCR. The sensitivity of ICG assay with IgM and IgG combinatorial detection in nucleic acid confirmed cases were 11.1%, 92.9% and 96.8% at the early stage (1–7 days after onset), intermediate stage (8–14 days after onset), and late stage (more than 15 days), respectively. The ICG detection capacity in nucleic acid-negative suspected cases was 43.6%. In addition, the concordance of whole blood samples and plasma showed Cohen's kappa value of 0.93, which represented the almost perfect agreement between two types of samples. In conclusion, serological ICG strip assay in detecting SARS-CoV-2 infection is both sensitive and consistent, which is considered as an excellent supplementary approach in clinical application.
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              Outbreak of scrub typhus in Puducherry & Tamil Nadu during cooler months

              Selvaraj Stephen, Balakrishnan Sangeetha, Stanley Ambroise … (2015)
              Background & objectives: The southern part of India has witnessed an increase in scrub typhus (ST) during the past ten years. ST outbreaks occurred during winter months but at intervals of one to three years. With only a few reports of ST in Puducherry, this study was undertaken to look for the persistence of ST cases in Puducherry and Tamil Nadu in the winter months. Methods: During relatively cooler months of September, 2012 to March, 2013, a total of 45 patients with fever and clinical suspicion of ST and who provided both acute and convalescent blood samples were included. Total WBC, platelet counts, serum creatinine, liver enzymes levels and a rapid immunochromatographic test (RICT) for ST were first done. Paired serum samples were analysed by two specific tests - ST IgM and IgG ELISA- and a non-specific, but widely used Weil-Felix (WF) test. Results: Of the 45 patients, 21 adults and seven children were confirmed as ST based on clinical and laboratory findings, and positivity in specific serological test(s). Setting ST IgM and IgG ELISA as reference, the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for RICT were 91.67, 85.71 per cent; 90.48, 100 per cent; 91.67, 100 per cent and 90.48, 80.95 per cent, respectively. Similarly, for WF the values were 83.33, 75 per cent; 95.24, 100 per cent; 95.24, 100 per cent and 83.33, 70.83 per cent, respectively. Interpretation & conclusions: ST continues to persist in the cooler months in Puducherry and neighbouring Tamil Nadu with fever and myalgia as prominent features. None of the tests evaluated in this study was found to be ideal, but ST IgM/IgG ELISA was useful for batch testing and the non-specific WF test can be used in resource poor settings.
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                Author and article information

                Journal
                Journal ID (publisher): JBCAHS
                Title: SBV Journal of Basic, Clinical and Applied Health Science
                Abbreviated Title: JBCAHS
                Publisher: Jaypee Brothers Medical Publishers
                ISSN (Print): 2582-5593
                ISSN (Electronic): 2581-6039
                Publication date (Print): July-September 2020
                Volume: 3
                Issue: 3
                Pages: 104-106
                Affiliations
                [1,2 ]Department of Microbiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed to be University), Puducherry, India
                Author notes
                Selvaraj Stephen, Department of Microbiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed to be University), Puducherry, India, Phone: +91 9894383368, e-mail: selvarajstephen@mgmcri.ac.in
                Article
                DOI: 10.5005/jp-journals-10082-02252
                SO-VID: 79fa8b1c-2f31-42da-83ef-70fdcd3c744a
                Copyright © Copyright © 2020; Jaypee Brothers Medical Publishers (P) Ltd.
                License:

                © The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and non-commercial reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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                ScienceOpen disciplines: General medicine,Immunology,Health & Social care,Public health,Infectious disease & Microbiology,Microbiology & Virology
                Keywords: COVID-19,Immunochromatographic test,Coronavirus,SARS-CoV 2
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                ScienceOpen disciplines: General medicine, Immunology, Health & Social care, Public health, Infectious disease & Microbiology, Microbiology & Virology
                Keywords: COVID-19, Immunochromatographic test, Coronavirus, SARS-CoV 2

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