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Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2.

ABSTRACT: OBJECTIVES:We aimed to evaluate the role of rapid serological tests in the management of coronavirus disease 2019 (COVID-19) patients. METHODS:This retrospective study enrolled 16 real-time reverse transcription polymerase chain reaction-confirmed symptomatic patients with COVID-19 and 58 COVID-19 negative patients at a medical center in Taiwan over a 3-month period. Serial serum samples were collected and tested for antibody response using four point-of-care (POC) lateral flow immunoassays (LFIA) (ALLTEST 2019-nCoV IgG/IgM Rapid Test, Dynamiker 2019-nCoV IgG/IgM Rapid Test, ASK COVID-19 IgG/IgM Rapid Test, and Wondfo SARS-CoV-2 Antibody Test). Time-dependent detection sensitivity and timeliness of seroconversion were determined and compared between the four POC rapid tests. RESULTS:The overall sensitivity and specificity of the four tests for detecting anti-SARS-CoV-2 antibodies after 3 weeks of symptom onset were 100% and 100%, respectively. There was no significant difference between the rapid tests used for detection of IgM and IgG separately and those used for detection of combined total antibody (mainly IgM/IgG). There was no significant difference between the four POC rapid tests in terms of time required for determining seroconversion of COVID-19. Patients with COVID-19 with pneumonia demonstrated shorter seroconversion time than those without pneumonia. CONCLUSION:Though the POC antibody rapid tests based on LFIA showed reliable performance in the detection of SARS-CoV-2-specific antibodies, the results of these tests should be interpreted and applied appropriately in the context of antibody dynamic of COVID-19 infection. COVID-19 patients complicated with pneumonia exhibited earlier anti-SARS-CoV-2 antibody response than COVID-19 patients without pneumonia.

SUBMITTER: Wu JL

PROVIDER: S-EPMC7295501 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2.

Wu Jhong-Lin JL Tseng Wen-Pin WP Lin Chien-Hao CH Lee Tai-Fen TF Chung Ming-Yi MY Huang Chien-Hua CH Chen Shey-Ying SY Hsueh Po-Ren PR Chen Shyr-Chyr SC

The Journal of infection 20200615 3

<h4>Objectives</h4>We aimed to evaluate the role of rapid serological tests in the management of coronavirus disease 2019 (COVID-19) patients.<h4>Methods</h4>This retrospective study enrolled 16 real-time reverse transcription polymerase chain reaction-confirmed symptomatic patients with COVID-19 and 58 COVID-19 negative patients at a medical center in Taiwan over a 3-month period. Serial serum samples were collected and tested for antibody response using four point-of-care (POC) lateral flow im ...[more]

PMID: 32553841

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Project description:Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine coverage remains incomplete, being only 15% in low-income countries. Rapid point-of-care tests predicting SARS-CoV-2 infection susceptibility in the unvaccinated may assist in risk management and vaccine prioritization. We conducted a prospective cohort study in 2,826 participants working in hospitals and Fire and Police services in England, UK, during the pandemic (ISRCTN5660922). Plasma taken at recruitment in June 2020 was tested using four lateral flow immunoassay (LFIA) devices and two laboratory immunoassays detecting antibodies against SARS-CoV-2 (UK Rapid Test Consortium's AbC-19 rapid test, OrientGene COVID IgG/IgM rapid test cassette, SureScreen COVID-19 rapid test cassette, and Biomerica COVID-19 IgG/IgM rapid test; Roche N and Euroimmun S laboratory assays). We monitored participants for microbiologically confirmed SARS-CoV-2 infection for 200 days. We estimated associations between test results at baseline and subsequent infection, using Poisson regression models adjusted for baseline demographic risk factors for SARS-CoV-2 exposure. Positive IgG results on each of the four LFIAs were associated with lower rates of subsequent infection with adjusted incidence rate ratios (aIRRs) of 0.00 (95% confidence interval, 0.00 to 0.01), 0.03 (0.02 to 0.05), 0.07 (0.05 to 0.10), and 0.09 (0.07 to 0.12), respectively. The protective association was strongest for AbC-19 and SureScreen. The aIRR for the laboratory Roche N antibody assay at the manufacturer-recommended threshold was similar to those of the two best performing LFIAs at 0.03 (0.01 to 0.10). Lateral flow devices measuring SARS-CoV-2 IgG predicted disease risk in unvaccinated individuals over a 200-day follow-up. The association of some LFIAs with subsequent infection was similar to laboratory immunoassays. IMPORTANCE Previous research has demonstrated an association between the detection of antibodies to SARS-CoV-2 following natural infection and protection from subsequent symptomatic SARS-CoV-2 infection. Lateral flow immunoassays (LFIAs) detecting anti-SARS-CoV-2 IgG are a cheap, readily deployed technology that has been used on a large scale in population screening programs, yet no studies have investigated whether LFIA results are associated with subsequent SARS-CoV-2 infection. In a prospective cohort study of 2,826 United Kingdom key workers, we found positivity in lateral flow test results had a strong negative association with subsequent SARS-CoV-2 infection within 200 days in an unvaccinated population. Positivity on more-specific but less-sensitive tests was associated with a markedly decreased rate of disease; protection associated with testing positive using more sensitive devices detecting lower levels of anti-SARS-CoV-2 IgG was more modest. Lateral flow tests with high specificity may have a role in estimation of SARS-CoV-2 disease risk in unvaccinated populations.

Project description:BackgroundThe novel coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which has quickly spread worldwide since its outbreak in December 2019. One of the primary measures for controlling the spread of SARS-CoV-2 infection is an accurate assay for its diagnosis. SARS-CoV-2 real-time PCR kits suffer from some limitations, including false-negative results in the clinic. Therefore, there is an urgent need for the development of a rapid antibody test kit for COVID-19 diagnosis.MethodsThe nuclear capsid protein (N) and spike protein 1 (S1) fragments of SARS-CoV-2 were expressed in Escherichia coli, and rapid antibody-based tests for the diagnosis of SARS-CoV-2 infection were developed. To evaluate their clinical applications, the serum from COVID-19 patients, suspected COVID-19 patients, recovering COVID-19 patients, patients with general fever or pulmonary infection, doctors and nurses who worked at the fever clinic, and health professionals was analyzed by the rapid antibody test kits. The serum from patients infected with Mycoplasma pneumoniae and patients with respiratory tract infection was further analyzed to test its cross-reactivity with other respiratory pathogens.ResultsA 47 kDa N protein and 67 kDa S1 fragment of SARS-CoV-2 were successfully expressed, purified, and renatured. The rapid antibody test with recombinant N protein showed higher positive rate than the rapid IgM antibody test with recombinant S1 protein. Clinical evaluation showed that the rapid antibody test kit with recombinant N protein had 88.56 % analytical sensitivity and 97.42 % specificity for COVID-19 patients, 53.48 % positive rate for suspected COVID-19 patients, 57.14 % positive rate for recovering COVID-19 patients, and 0.5-0.8 % cross-reactivity with other respiratory pathogens. The analytical sensitivity of the kit did not significantly differ in COVID-19 patients with different disease courses (p < 0.01).ConclusionsThe rapid antibody test kit with recombinant N protein has high specificity and analytical sensitivity, and can be used for the diagnosis of SARS-CoV-2 infection combined with RT-PCR.

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Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2.

Publications

Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2.

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