Evaluation of SARS-CoV-2 antigen-based rapid diagnostic kits in Pakistan: formulation of COVID-19 national testing strategy

Autor: Azhar Rasheed, Hafsah Zaheer, Umar Saeed, Zahra Zahid Piracha, Zubair Aftab, Rizwan Uppal, Sara Rizwan Uppal
Rok vydání: 2021
Předmět:
Adult
Male
0301 basic medicine
Test strategy
Saliva
medicine.medical_specialty
Adolescent
Coronavirus disease 2019 (COVID-19)
Cross-sectional study
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Population
Short Report
RT-PCR
Biology
Real-Time Polymerase Chain Reaction
COVID-19 Serological Testing
lcsh:Infectious and parasitic diseases
Young Adult
03 medical and health sciences
0302 clinical medicine
Antigen
Virology
Internal medicine
medicine
Humans
Pakistan
lcsh:RC109-216
030212 general & internal medicine
Child
education
Antigens
Viral
Aged
Aged
80 and over
Rapid diagnostic testing
education.field_of_study
SARS-CoV-2
Reproducibility of Results
COVID-19
Gold standard (test)
Middle Aged
Cross-Sectional Studies
030104 developmental biology
Infectious Diseases
Female
Nasopharyngeal swab
Reagent Kits
Diagnostic
Zdroj: Virology Journal, Vol 18, Iss 1, Pp 1-5 (2021)
Virology Journal
DOI: 10.21203/rs.3.rs-113852/v2
Popis: Rapid diagnosis of SARS-CoV-2 during pandemic enables timely treatment and prevention of COVID-19. Evaluating the accuracy and reliability of rapid diagnostic testing kits is crucial for surveillance and diagnosis of SARS-CoV-2 infections in general population, injection drug users, multi-transfused populations, healthcare workers, prisoners, barbers and other high risk populations. The aim of this study was to evaluate performance and effectiveness of nasopharyngeal swab (NSP) and saliva based rapid antigen detection testing kits in comparison with USFDA approved triple target gold standard real-time polymerase chain reaction. A cross-sectional sectional study was conducted on 33,000 COVID-19 suspected patients. From RT-PCR positive patients, nasopharyngeal swab (NSP) and saliva samples were obtained for evaluation of rapid COVID-19 testing kits (RDT). 100/33000 (0.3%) of specimens were RT-PCR positive for SARS-CoV-2. Among RT-PCR positive, 62% were males, 34% were females, and 4% were children. The NSP-RDT (Lepu Medical China) analysis revealed 53% reactivity among males, 58% reactivity among females, and 25% reactivity among children. However saliva based RDT (Lepu Medical China) analysis showed 21% reactivity among males and 23% among females, and no reactivity in children. False negative results were significantly more pronounced in saliva based RDT as compared to NSP-RDT. The sensitivity of these NSP-RDT and saliva based RDT were 52% and 21% respectively. The RDTs evaluated in this study showed limited sensitivities in comparison to gold standard RT-PCR, indicating that there is a dire need in Pakistan for development of suitable testing to improve accurate COVID-19 diagnosis in line with national demands.
Databáze: OpenAIRE
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