Medical Devices: Evidence and Research (Mar 2024)
Lesson Learned from Mass Antibody Rapid Diagnostic Used in the Early COVID-19 Pandemic in Indonesia Contributors
Abstract
Agnes Rengga Indrati,1 Luhung Budiailmiawan,2 Louisa Markus,3 Johanis Johanis,4 Verina Logito,1 Aryati5 1Department of Clinical Pathology, Faculty of Medicine Padjadjaran University/ Dr. Hasan Sadikin General Hospital, Bandung City, West Java, Indonesia; 2Department of Clinical Pathology, Pelabuhan Ratu Hospital, Sukabumi, West Java, Indonesia; 3Department of Clinical Pathology, Sidawangi Lung Hospital, Cirebon, West Java, Indonesia; 4Department of Clinical Pathology, Cengkareng Hospital, West Jakarta, Indonesia; 5Department of Clinical Pathology, Faculty of Medicine Airlangga University / Dr. Soetomo General Academic Hospital, Surabaya, East Java, IndonesiaCorrespondence: Agnes Rengga Indrati, Email [email protected]: Laboratory examination is extremely important in handling the COVID-19 pandemic. In the first era of the pandemic, the molecular and antigen tests were limited. Hence, at that time, it was necessary to carry out antibody Rapid Diagnostic Tests (RDT). However, many antibody RDTs were yet to obtain Food and Drug Authorization (FDA)’s approval.Purpose: Therefore, The Indonesian Association of Clinical Pathology and Medical Laboratory (PDS PatKLIn) decided to conduct a validity test of RDT antibodies to find out the quality of SARS-CoV-2 diagnosis performance based on these RDTs used.Patient and Methods: This is a descriptive observational design with diagnostic analysis. The retrospective secondary data were collected from 34 provinces in Indonesia from May to June 2020. Data analysis was carried out on the sensitivity and specificity values of each antibody RDT brand to the RT-PCR result and analyzed descriptive data.Results: The amount of secondary data of antibody RDT and RT-PCR results collected was 139,908, consisting of 59 RDT brands of which 44% were authorized by The Indonesian COVID-19 Response Acceleration Task Force (Gugus Tugas Percepatan Penanganan COVID-19 Indonesia). There were huge variations of SARS-CoV-2 antibody RDT performance between total antibody types (sensitivity 59.18%, specificity 62%), IgM RDT (sensitivity 16– 100%, specificity 7– 97%), and RDT IgG (sensitivity 33– 96%, specificity 19– 100%).Conclusion: The variations in the RDT antibodies’performance can cause errors in diagnosis leading to significant material and immaterial losses. Therefore, cooperation from various parties is needed for the pre- and post-marketing surveillance process to assess the performance and the characteristics of each RDT kit and other diagnostic methods to assist the rapid pandemic response process.Keywords: antibody rapid diagnostic test, SARS-CoV-2, COVID-19
