Performance Validation of COVID-19 Self-Conduct Buccal and Nasal Swabs RTK-Antigen Diagnostic Kit.

Mohammad Nur Amin Kalil,Afifah Sjamun Sjahid,Mohd Hashairi Fauzi,Naveed Ahmed,Rosline Hassan,Wardah Yusof,Mimi Azliha Abu Bakar,Chan Yean Yean

doi:10.3390/diagnostics11122245

Mohammad Nur Amin Kalil, Afifah Sjamun Sjahid + Show 6 more

Open Access

https://doi.org/10.3390/diagnostics11122245

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Abstract

The antigen rapid diagnostic test (Ag-RDT) is an immunodiagnostic test that detects the presence of viral proteins (antigens) expressed by the COVID-19 virus in a sample from a patient’s respiratory tract. This study focused on evaluating the performance of self-conduct buccal and nasal swabs RTK-antigen test compared to nasopharyngeal swab RTK-based COVID-19 diagnostic assays, Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal) (Abbott Rapid Diagnostics Jena GmbH, Jena, Germany) used in hospitals for first-line screening. The sensitivity and specificity of the paired RTK-Ag test in detecting the an-tigen were calculated at 96.4% and 100%, respectively. Fisher exact tests showed the association between nasopharyngeal swabs RTK-Ag assay and buccal-nasal swabs RTK-Ag from ProdetectTM is significant (p-values < 0.001). The result showed that a self-conducted buccal and nasal RTK-antigen rapid test by the patients is comparable to the results obtained from a rapid test device conducted by trained medical personnel using a nasopharyngeal swab.

Highlights

COVID-19 is an infectious disease caused by the SARS-CoV-2 virus
Diagnoses are made from nasopharyngeal swab specimens and the virus is identified using quantitative reverse transcription-PCR (RT-qPCR) assays performed according to World Health Organization (WHO) guidelines to detect SARSCoV-2
Study participants (n = 120) who had previously tested positive for SARS-CoV-2 by rapid test kit (RTK)-Ag test test performed at Emergency Department of Hospital Universiti Sains Malaysia (HUSM) were recruited with no age and gender limitation

Summary

Introduction

COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. The clinical spectrum of the disease is heterogeneous, ranging from asymptomatic to severe respiratory disease and death commonly manifested with fever, cough, loss of sense of smell and shortness of breath [1]. Diagnoses are made from nasopharyngeal swab specimens and the virus is identified using quantitative reverse transcription-PCR (RT-qPCR) assays performed according to World Health Organization (WHO) guidelines to detect SARSCoV-2. Detecting antibodies for previous exposure cases through rapid test kit (RTK)-antibody rapid lateral flow assays is uncertain for seroprevalence studies [2,3]. There are developed RT-qPCR kits that do not need viral RNA extraction and high-throughput RT-qPCR equipment [3]. Such tests are commonly used in public health laboratories and larger, well-equipped hospitals, they are not accessible in small clinics. Human samples are transferred to facilities with RT-qPCR capacity, delaying test results for suspected COVID19 patients [1]. The expensive and time-consuming RT-qPCR necessitates specialized equipment and well-trained laboratory staff [6]

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