Daniel Mekonnen^1,2,3#*, Hylemariam Mihiretie Mengist^1,2#, Awoke Derbie^3,4, Endalkachew Nibret⁵, Abaineh Munshea⁵, Hongliang He^1,2, Tengchuan Jin^1,2

¹Department of Obstetrics and Gynecology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, China. ²Hefei National Laboratory for Physical Sciences at Microscale, Laboratory of Structural Immunology, CAS Key Laboratory of Innate Immunity and Chronic Disease, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230027, China. ³Department of Medical Microbiology, Immunology and Parasitology, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia. ⁴The Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDTAfrica), Addis Ababa University, Addis Ababa, Ethiopia. ⁵Department of Biology, Bahir Dar University, Bahir Dar, Ethiopia. ^#these authors contributed equally to this work

^*Correspondence: Daniel Mekonnen: nigusdaniel@gmail.com; +252912990288

Abstract

Background and setting: It is ultimately necessary to select the most reliable and affordable serological diagnostic methods. Here we report the diagnostic test accuracy (DTA) of SARS-COV-2 serological test methods and the kinetics of antibody positivity.

Methods: Studies evaluating the diagnostic accuracy of serological tests and the kinetics of antibody positivity were included in the review. MEDLINE through PubMed, Scopus, medRxiv and bioRxiv were sources of articles. Metandi performs bivariate meta-analysis of DTA using a generalized linear mixed model approach. The DTA evaluation was disaggregated by assay, antigen and antibody types. Similarly, the kinetic of antibody was determined over 1-10, 11-15, 16-20 and ≥21 days post symptom onset (DPSO).

Results: The summary sensitivity/specificity of CLIA, ELISA and LFIA were 92% (95% CI: 86-95%)/99% (CI: 97-99%), 86% (CI: 82-89%)/99% (CI: 98-100%), and 78 % (CI: 71-83%)/98% (95%CI: 96-99%), respectively. Moreover, CLIA based assays produced nearly 100% sensitivity within 11-15 DPSO. The sensitivity of ELISA-total antibody, CLIA-IgM/G, CLIA-IgG gauged at 94%, 92% and 92%, respectively.  The sensitivity of CLIA-RBD assay reached to 96%.

Conclusions: CLIA assays targeting antibody against RBD demonstrated better DTA. The DTA of LFIA is suboptimal. The antibody positivity rate increase as dpso increase. However, some decrement was noticed as one moves from acute phase to convalescent phase of SARS-COV-2 infection. Immunoglobulin isotope related DTA is heterogeneous and need further investigation. Hence, no enough evidence is found for recommending the use of serological tests for clinical decision making but likely to have comparative advantage over RT-PCR in certain circumstances and geographic regions.

Key words: Kinetics of antibody, Diagnostic accuracy, Serological tests, SARS-CoV-2