Validation and performance comparison of two SARS-CoV-2 IgG/IgM rapid tests

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a disease called COVID-19. COVID-19 is primarily diagnosed using molecular techniques mainly real-time reverse transcriptase PCR. Reliable and accurate serologic assays for COVID-19, are an important tool for surveillance and epidemiologic studies. In this study, the IgG/IgM Rapid Test Cassette and the Prima COVID-19 IgG/IgM Rapid Test for the detection of SARS-CoV-2 antibodies in blood, serum and plasma samples collected from patients up to 48 days after symptom onset in Saudi Arabia were validated. Overall, both tests showed poor performance and cannot be utilised for COVID-19 diagnosis as a point of care test or to determine seroprevalence.

COVID-19 testing in Delaware’s underserved communities: demographic and social determinants of testing inequality

“…Typically, these antibodies (i.e., IgG and IgM) are produced as part of the body’s immune response. These antibodies have been found to be present in those who were symptomatic or asymptomatic as early as 14 days after symptom onset [ 2 , 3 ]. The sensitivity and specificity of the test were found to be greater than 90% for detecting the presence of viral infection from samples of human blood [ 3 ], with IgG antibodies detectable more than four months post-infection [ 13 ].…”

“…The "Other Race/Unknown" category included respondents identifying as Asian (n = 4), Native American (n = 24), Pacific Islander (n = 1), Multi-race (n = 40), other race (n = 4), or unknown (n = 55). The socioeconomic variables included educational level as a categorical variable (i.e., less than high school, high school diploma, some college, and bachelors degree or higher), county of residence as a categorical variable (i.e., New Castle, Kent, or Sussex), family income in 2020 3 as a categorical variable indicating whether respondents' family income in 2020 was higher or lower than $20,000 or unknown (unknown = 0, family income $20k and higher = 1, family income lower than $20k = 2), health insurance status as a binary variable (no insurance = 0), and perceived neighborhood safety as a binary variable (yes = 1). It should be noted that family income was included on the survey as a categorical variable.…”

“…An antibody test can detect the presence of IgG and IgM antibodies typically found in individuals with previous coronavirus infection (SARS-Co-V-2). The IgG and IgM antibodies are produced as part of the body’s immune response in both symptomatic and asymptomatic cases and can be detected as early as 14 to 48 days post-infection [ 2 , 3 ]. The serology test has public health value for monitoring and responding to the ever-changing pandemic, especially when tracking past infections, which are not always detectable by tests for the virus [ 4 ]; however, both the CDC and the FDA have indicated that antibody testing cannot be used to replace tests for the virus in detecting current COVID-19 infection.…”

Performance Ranking of Diagnostic SARS-CoV-2 IgG Antibody Tests by Using Multi-Criteria Decision-Making Theory

“…[9][10][11]. To predict the diagnostic feasibility of different antibody platforms used for diagnosis and epidemiological investigations, IgG measurements obtained from COVID-19 cases in various serological platforms such as point of care or automated systems, nucleocapsid or spike protein-based ELISAs, LFAs, CMIAs, etc., have been investigating during different phases of the infection (5-9 days / ≥15 days of symptom onset) [9], [12], [13]. As with such difficult and time-consuming analyzes, the performance of only a limited number of serological tests can be compared, more practical applications should be preferred.…”