Evaluation of SARS-CoV2 antibody Rapid Diagnostic Test kits (RDTs) Innovita® and Real Time-Polymerase Chain Reaction (Rt-PCR) for COVID-19 infection diagnosis in Kaduna State, Nigeria.

OT Ige; AS Buru; S Ige; MT Ibrahim; D Livingstone; I Ijei; H Beloo-Manga; O Jimoh; G Nmadu; Z Lamido-Tanko; R Audu

doi:10.5281/zenodo.7065930

Authors

OT Ige Departments of Medical Microbiology and Parasitology, Faculty of Basic Clinical Sciences, College of Medicine, BDTH, Kaduna State University, Kaduna, Nigeria. https://orcid.org/0000-0002-2025-1160
AS Buru Departments of Medical Microbiology and Parasitology, Faculty of Basic Clinical Sciences, College of Medicine, BDTH, Kaduna State University, Kaduna, Nigeria. https://orcid.org/0000-0003-1453-7506
S Ige Departments of Paediatrics, Faculty of Basic Clinical Sciences, College of Medicine, BDTH, Kaduna State University, Kaduna, Nigeria.
MT Ibrahim Department of Medical Laboratory Science, Faculty of Health Sciences, College of Medicine, Ahmadu Bello University Zaria, Nigeria
D Livingstone Departments of Haematology and Blood Transfusion, Faculty of Basic Clinical Sciences, College of Medicine, BDTH, Kaduna State University, Kaduna, Nigeria. https://orcid.org/0000-0002-9603-6512
I Ijei Departments of Haematology and Blood Transfusion, Faculty of Basic Clinical Sciences, College of Medicine, BDTH, Kaduna State University, Kaduna, Nigeria. https://orcid.org/0000-0001-5669-2139
H Beloo-Manga Departments of Haematology and Blood Transfusion, Faculty of Basic Clinical Sciences, College of Medicine, BDTH, Kaduna State University, Kaduna, Nigeria.
O Jimoh Department of Medical Microbiology and Parasitology, Faculty of Basic Clinical Sciences, College of Medicine, Ahmadu Bello University, Kaduna, Nigeria
G Nmadu Departments of Community Medicine, Faculty of Basic Clinical Sciences, College of Medicine, BDTH, Kaduna State University, Kaduna, Nigeria. https://orcid.org/0000-0001-7813-6723
Z Lamido-Tanko Departments of Medical Microbiology and Parasitology, Faculty of Basic Clinical Sciences, College of Medicine, BDTH, Kaduna State University, Kaduna, Nigeria.
R Audu Departments of Medical Microbiology and Parasitology, Faculty of Basic Clinical Sciences, College of Medicine, BDTH, Kaduna State University, Kaduna, Nigeria.

DOI:

: https://doi.org/10.5281/zenodo.7065930

Keywords:

Rapid Diagnostic Test kits, Real Time-Polymerase Chain Reaction (Rt-PCR), SARS-CoV-2

Abstract

Background: The Real-Time Polymerase Chain Reaction (Rt-PCR) is the gold standard diagnostic test for SARS-CoV-2, however, there are several invalidated antibody-based tests available for community screening. This study compared the performance of the SARS-CoV-2 antibody test kits and Rt-PCR in the diagnosis and surveillance of COVID-19 infection. Methodology: The study was conducted at the Infectious diseases control center (IDCC), Kaduna and Hamdala Motel isolation center, of Kaduna State, using a cross-sectional study design. The sample size, of 521 was achieved by the convenience sampling method over a period of three months. Venous blood samples, collected from consenting clients and patients were analyzed for SARS-CoV-2, using the kit by Innovita® Biological Technology CO., LTD China. Oral/nasopharyngeal swabs were collected and analyzed using the Rt-PCR. Data analysis was carried out using the SPSS version 23. Proportions were compared using Chi-square tests for proportions. The level of statistical significance was set at p ≤ 0.05. Result: Our study revealed low sensitivity for both IgM (14.4%) and IgG (15.6%), using the RDT antibody kits, with the specificity of 92.9% and 98.6% for IgM and IgG. Using PCR-positive cases as true positives, the accuracy of the test was 67.8% and 72.0% for IgM and IgG, respectively. The positive and negative predictive values for IgM were 48.9% and 69.7%. For IgG, the corresponding values were 83.9% and 71.2%. Conclusion: The SARS-CoV-2 Innovita® RDT kit is far from ideal as a tool for the rapid seroprevalence survey of Covid-19 with its low sensitivity. More efforts are urgently required to access standard diagnostic kits, with a high sensitivity/specificity index when compared with the gold standard, for community screening, especially in the regions not easily accessible due to a number of reasons.