Serology or antibody tests for COVID-19 are designed to detect antibodies (mainly Immunoglobulin M (IgM) and Immunoglobulin G (IgG) produced in response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) infection. In this study, 30 lateral flow immunoassays were tested using serum or plasma from patients with confirmed SARS CoV-2 infection. Negative serological controls were accessed from a well-characterised bank of sera which were stored prior to February 2020. Operational characteristics and ease of use of the assays are reported. 4/30 (13%) of kits (Zheihang Orient Gene COVID-19 IgG/IgM, Genrui Novel Coronavirus (2019-nCoV) IgG/IgM, Biosynex COVID-19 BSS IgG/IgM, Boson Biotech 2019-nCoV IgG/IgM) were recommended for SAHPRA approval based on kit sensitivity. Of these, only the Orientgene was recommended by SAHPRA in August 2020 for use within the approved national testing algorithm while the remaining three received limited authorization for evaluation. All kits evaluated work on the same basic principle of immunochromatography with minor differences noted in the shape and colour of cartridges, the amount of specimen volume required and the test duration. Performance of the lateral flow tests were similar to sensitivities and specificities reported in other studies. The cassettes of the majority of kits evaluated (90%) detected both IgG and IgM. Only 23% of kits evaluated contained all consumables required for point-of-care testing. The study highlights the need for thorough investigation of kits prior to implementation.
【저자키워드】 COVID-19, SARS-CoV2, point-of-care, Lateral flow immunoassays, 【초록키워드】 SARS CoV-2, severe acute respiratory syndrome coronavirus 2, immunochromatography, IgG, IgM, coronavirus, serology, antibody, 2019-nCoV, Infection, coronavirus 2, Novel coronavirus, Severe acute respiratory syndrome, lateral flow immunoassay, serum, sensitivity, specificity, Immunoglobulin G, Characteristics, Lateral flow test, Immunoglobulin, antibody tests, sera, implementation, Algorithm, Patient, Control, plasma, Antibody test, novel, respiratory, performance, serological, 2019, Lateral flow tests, immunoglobulin M, IgG and IgM, SARS CoV-2 infection, Volume, SARS CoV, specimen, shape, approval, nCoV, sensitivities, National, Specificities, Orient, cassette, negative, Boson, cassettes, highlight, produced, tested, detect, reported, evaluated, required, approved, majority, BSS, 【제목키워드】 lateral flow immunoassay, Characteristics, COVID-19 immune response, identify,