Rapid diagnostic testing for SARS‐CoV‐2: Validation and comparison of three point‐of‐care antibody tests. Issue 7 (3rd May 2021)

• Record Type: Journal Article
• Authors: Strand, Rasmus; Thelaus, Louise; Fernström, Nils; Sunnerhagen, Torgny; Lindroth, Ylva; Linder, Adam; Rasmussen, Magnus
• Other Names: Luo Guangxiang (George) guestEditor.; Ly Hinh guestEditor.; Gao Shou‐Jiang guestEditor.
• Is Part Of: Journal of medical virology. Volume 93:Issue 7(2021)
• Page Start: 4592
• Page End: 4596
• Publication Date: 2021-05-03
• Subjects: COVID‐19 -- point‐of‐care test -- SARS‐CoV‐2 -- sensitivity -- specificity -- validation; Virology -- Periodicals; 616
• DOI: 10.1002/jmv.26913
• Languages: English
• ISSNs: 0146-6615

Abstract

Abstract: With the emergence of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), a need for diagnostic tests has surfaced. Point‐of‐care (POC) antibody tests can detect immunoglobulin (Ig) G and M against SARS‐CoV‐2 in serum, plasma, or whole blood and give results within 15 min. Validation of the performance of such tests is needed if they are to be used in clinical practice. In this study, we evaluated three POC antibody tests. Convalescent serum samples from 47 reverse transcription‐polymerase chain reaction (RT‐PCR) verified patients with coronavirus disease 2019 (COVID‐19) collected at least 28 days post RT‐PCR diagnosis as well as 50 negative pre‐COVID‐19 controls were tested. The three tests (denoted the J‐, N‐, and Z‐tests) displayed the sensitivities of 87%, 96%, and 85%, respectively, for the detection of IgG. All tests had the same specificity for IgG (98%). The tests did not differ significantly for the detection of IgG. The sensitivities for IgM were lower (15%, 67%, and 70%) and the specificities were 90%, 98%, and 90%, respectively. The positive and negative predictive values were similar among the tests. Our results indicate that these POC antibody tests might be accurate enough to use in routine clinical practice. Highlights: The vast majority of patients with verified COVID‐19 had developed IgG antibodies that could be detected with three different point‐of‐care SARS‐CoV‐2 antibody detection tests four weeks after infection. The tests had high sensitivity and specificity to detect anti‐SARS‐CoV‐2 IgG and but more variable sensitivity and specificity to detect IgM.