Evaluation of Novel Antigen-Based Rapid Detection Test for the Diagnosis of SARS-CoV-2 in Respiratory Samples

Porte, Lorena; Legarraga, Paulette; Vollrath, Valeska; Aguilera, Ximena; Munita, José M.; Araos, Rafael; Pizarro, Gabriel; Vial, Pablo; Dittrich, Sabine; Weitzel, Thomas

doi:10.2139/ssrn.3569871

Cited by 50 publications

(69 citation statements)

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“…Similar study from China, reported 68% sensitivity in 208 RT-PCR con rmed nasopharyngeal swab samples (25). Porte et al, 2020 evaluated uorescence immunochromatographic SARS-CoV-2 antigen test with nasopharyngeal and oropharyngeal swabs from 127 samples including 82 RT-PCR con rmed patients, with overall sensitivity of 93.9% (26).…”

Section: Discussionmentioning

confidence: 86%

Evaluation of SARS-CoV-2 Antigen-Based Rapid Diagnostic Kits in Pakistan: Formulation of COVID-19 National Testing Strategy.

Saeed

Uppal²,

Piracha³

et al. 2020

Preprint

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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.

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Section: Discussionmentioning

confidence: 86%

Evaluation of SARS-CoV-2 Antigen-Based Rapid Diagnostic Kits in Pakistan: Formulation of COVID-19 National Testing Strategy.

Saeed

Uppal²,

Piracha³

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

“…Moreover, in recent guidance, the WHO proposed settings where antigen RDTs can be used in patient management ( WHO, 2020b ). However, there have been few field evaluations of these antigen RDTs ( Scohy et al, 2020 , Porte et al, 2020 , Lambert-Niclot et al, 2020 , Mertens et al, 2020 , Diao et al, 2020 , Mak et al, 2020 , ICMR, 2020 ) and those evaluated yielded disappointing results in terms of their performance.…”

Section: Introductionmentioning

confidence: 99%

Field evaluation of the performance of a SARS-CoV-2 antigen rapid diagnostic test in Uganda using nasopharyngeal samples

Nalumansi

Lutalo

Kayiwa

et al. 2021

International Journal of Infectious Diseases

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Highlights High global demand for SARS-CoV-2 testing to identify COVID-19 cases. qRT-PCR recommended diagnostic test but constraints such as cost prevent its use. Simple, low cost, and easy-to-use rapid antigen diagnostic tests urgently required. STANDARD Q COVID-19 Ag test exhibits less than optimal performance. Test may be used when molecular testing access is poor but qRT-PCR still required.

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“… 2 , 3 The current gold standard and the recommended diagnostic method for the diagnosis of COVID-19 is the detection of viral RNA in respiratory tract specimens by real-time reverse-transcription polymerase chain reaction (RT-PCR), which was introduced in January 2020 and is applied using World Health Organization (WHO) protocols. 4-6 …”

mentioning

confidence: 99%

Potential Use of Antigen-Based Rapid Test for SARS-CoV-2 in Respiratory Specimens in Low-Resource Settings in Egypt for Symptomatic Patients and High-Risk Contacts

Abdelrazik

Elshafie

Abdelaziz

2020

Laboratory Medicine

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Objective Because of the rapidly emerging SARS-CoV-2 pandemic and its wide public health challenges, rapid diagnosis is essential to decrease the spread. Antigen-based rapid detection tests are available; however, insufficient data about their performance are available. Methods The lateral-flow immunochromatographic BIOCREDIT COVID-19 antigen test was evaluated using nasopharyngeal swabs in a viral transport medium from patients with confirmed infection, contacts, and exposed healthcare professionals at Fayoum University Hospital in Egypt. Test performance was determined in comparison to the SARS-CoV-2 real-time reverse-transcription polymerase chain reaction (RT-PCR) test. Results Three hundred ten specimens from 3 categories—patients with confirmed diagnoses of COVID-19, contacts, and exposed healthcare professionals—were included; 188 specimens were RT-PCR-positive, from which 81 were detected by rapid antigen test. Overall sensitivity was 43.1%. Sensitivity was significantly higher in specimens with high viral loads. Conclusion Poor sensitivity of the BIOCREDIT COVID-19 test does not permit its use for diagnosis, and it can only be used in conjunction with RT-PCR for screening.

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Evaluation of Novel Antigen-Based Rapid Detection Test for the Diagnosis of SARS-CoV-2 in Respiratory Samples

Cited by 50 publications

References 0 publications

Evaluation of SARS-CoV-2 Antigen-Based Rapid Diagnostic Kits in Pakistan: Formulation of COVID-19 National Testing Strategy.

Evaluation of SARS-CoV-2 Antigen-Based Rapid Diagnostic Kits in Pakistan: Formulation of COVID-19 National Testing Strategy.

Field evaluation of the performance of a SARS-CoV-2 antigen rapid diagnostic test in Uganda using nasopharyngeal samples

Potential Use of Antigen-Based Rapid Test for SARS-CoV-2 in Respiratory Specimens in Low-Resource Settings in Egypt for Symptomatic Patients and High-Risk Contacts

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