Validation of rapid SARS-COV-2 antigen detection test as a screening tool for detection of Covid-19 infection at district hospital in northern India

Choudhary, Saba; Ishrat, Aishiya

doi:10.3126/ajms.v13i4.40765

Cited by 3 publications

(1 citation statement)

References 10 publications

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“…Among the studies done in India, the strength of agreement between these two tests ranged from moderate to almost perfect. A prospective study [21] done among 756 patients from a district hospital in North India shows a substantial agreement like ours with a κ value of 0.6482 (95% CI: 0.5801 to 0.7163). However, Pandey et al found moderate agreement between these two tests [22].…”

Section: Discussionsupporting

confidence: 87%

The Agreement Between Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) and Rapid Antigen Test (RAT) in Diagnosing COVID-19

Sahu¹,

Gupta²,

Rawat³

et al. 2022

Cureus

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BackgroundFalse-negative results derived from RT-PCR tests for diagnosing coronavirus disease have raised questions about whether to consider them the gold standard for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Using an imperfect gold standard to assess other diagnostic tests would never let the other tests show better diagnostic performance. The best strategy in such cases is to do an agreement analysis, and this study aims to estimate the agreement between real-time reverse transcriptase-polymerase chain reaction (RT-PCR) and rapid antigen test (RAT) for COVID-19 detection. MethodsA retrospective study was done using paired data of individuals tested for COVID-19, both by RT-PCR and RAT, obtained from the virology laboratory of Government Bundelkhand Medical College, Sagar, Madhya Pradesh, India. A sample size of 93 was calculated, and the data were abstracted in a data abstraction sheet. Variables included were results of RT-PCR and RAT, age, gender, presence of symptoms, test kit used, and the time duration between sampling for RT-PCR and RAT. Apart from descriptive statistics, keeping in mind the binary outcome of RT-PCR and RAT, Cohen's kappa was calculated for agreement analysis. A p-value of <0.05 was considered significant. ResultsThe data on 100 participants suspected to be infected with COVID-19 (58 male and 42 female) with a mean age of 39.8 (±19.0) years were analysed. The number of discordant pairs was eight. Cohen's kappa showed substantial agreement between RT-PCR and RAT, κ=0.646, (95% CI 0.420 to 0.871), p<0.001. ConclusionConsidering the ease of conducting RAT with quick results and substantial agreement with RT-PCR, RAT could be a better choice in detecting SARS-CoV-2 and, hence, COVID-19 disease on a large scale.

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Section: Discussionsupporting

confidence: 87%

The Agreement Between Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) and Rapid Antigen Test (RAT) in Diagnosing COVID-19

Sahu¹,

Gupta²,

Rawat³

et al. 2022

Cureus

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Comparison of diagnostic accuracy of rapid antigen tests for COVID19 compared to the viral genetic test in adults: a systematic review and meta-analysis

Hirabayashi,

Mercado,

Hull

et al. 2024

JBI Evidence Synthesis

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Objective: The objective of this review is to determine the diagnostic accuracy of the currently available and upcoming point-of-care rapid antigen tests (RATs) used in primary care settings relative to the viral genetic real-time reverse transcriptase polymerase chain reaction (RT-PCR) test as a reference for diagnosing COVID-19/SARS-CoV-2 in adults. Introduction: Accurate COVID-19 point-of-care diagnostic tests are required for real-time identification of SARS-CoV-2 infection in individuals. Real-time RT-PCR is the accepted gold standard for diagnostic testing, requiring technical expertise and expensive equipment that are unavailable in most primary care locations. RATs are immunoassays that detect the presence of a specific viral protein, which implies a current infection with SARS-CoV-2. RATs are qualitative or semi-quantitative diagnostics that lack thresholds that provide a result within a short time frame, typically within the hour following sample collection. In this systematic review, we synthesized the current evidence regarding the accuracy of RATs for detecting SARS-CoV-2 compared with RT-PCR. Inclusion criteria: Studies that included nonpregnant adults (18 years or older) with suspected SARS-CoV-2 infection, regardless of symptomology or disease severity, were included. The index test was any available SARS-CoV-2 point-of-care RAT. The reference test was any commercially distributed RT-PCR–based test that detects the RNA genome of SARS-CoV-2 and has been validated by an independent third party. Custom or in-house RT-PCR tests were also considered, with appropriate validation documentation. The diagnosis of interest was COVID-19 disease and SARS-CoV-2 infection. This review considered cross-sectional and cohort studies that examined the diagnostic accuracy of COVID-19/SARS-CoV-2 infection where the participants had both index and reference tests performed. Methods: The keywords and index terms contained in relevant articles were used to develop a full search strategy for PubMed and adapted for Embase, Scopus, Qinsight, and the WHO COVID-19 databases . Studies published from November 2019 to July 12, 2022, were included, as SARS-CoV-2 emerged in late 2019 and is the cause of a continuing pandemic. Studies that met the inclusion criteria were critically appraised using QUADAS-2. Using a customized tool, data were extracted from included studies and were verified prior to analysis. The pooled sensitivity, specificity, positive predictive, and negative predictive values were calculated and presented with 95% CIs. When heterogeneity was observed, outlier analysis was conducted, and the results were generated by removing outliers. Results: Meta-analysis was performed on 91 studies of 581 full-text articles retrieved that provided true-positive, true-negative, false-positive, and false-negative values. RATs can identify individuals who have COVID-19 with high reliability (positive predictive value 97.7%; negative predictive value 95.2%) when considering overall performance. However, the lower level of sensitivity (67.1%) suggests that negative test results likely need to be retested through an additional method. Conclusions: Most reported RAT brands had only a few studies comparing their performance with RT-PCR. Overall, a positive RAT result is an excellent predictor of a positive diagnosis of COVID-19. We recommend that Roche’s SARS-CoV-2 Rapid Antigen Test and Abbott’s BinaxNOW tests be used in primary care settings, with the understanding that negative results need to be confirmed through RT-PCR. We recommend adherence to the STARD guidelines when reporting on diagnostic data. Review registration: PROSPERO CRD42020224250

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SARS-CoV-2 Rapid Antigen Test Based on a New Anti-Nucleocapsid Protein Monoclonal Antibody: Development and Real-Time Validation

Coelho,

da Silva,

Lopes

et al. 2023

Microorganisms

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SARS-CoV-2 diagnostic tests have become an important tool for pandemic control. Among the alternatives for COVID-19 diagnosis, antigen rapid diagnostic tests (Ag-RDT) are very convenient and widely used. However, as SARS-CoV-2 variants may continuously emerge, the replacement of tests and reagents may be required to maintain the sensitivity of Ag-RDTs. Here, we describe the development and validation of an Ag-RDT during an outbreak of the Omicron variant, including the characterization of a new monoclonal antibody (anti-DTC-N 1B3 mAb) that recognizes the Nucleocapsid protein (N). The anti-DTC-N 1B3 mAb recognized the sequence TFPPTEPKKDKKK located at the C-terminus of the N protein of main SARS-CoV-2 variants of concern. Accordingly, the Ag-RDT prototypes using the anti-DTC-N 1B3 mAB detected all the SARS-CoV-2 variants—Wuhan, Alpha, Gamma, Delta, P2 and Omicron. The performance of the best prototype (sensitivity of 95.2% for samples with Ct ≤ 25; specificity of 98.3% and overall accuracy of 85.0%) met the WHO recommendations. Moreover, results from a patients’ follow-up study indicated that, if performed within the first three days after onset of symptoms, the Ag-RDT displayed 100% sensitivity. Thus, the new mAb and the Ag-RDT developed herein may constitute alternative tools for COVID-19 point-of-care diagnosis and epidemiological surveillance.

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Validation of rapid SARS-COV-2 antigen detection test as a screening tool for detection of Covid-19 infection at district hospital in northern India

Cited by 3 publications

References 10 publications

The Agreement Between Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) and Rapid Antigen Test (RAT) in Diagnosing COVID-19

The Agreement Between Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) and Rapid Antigen Test (RAT) in Diagnosing COVID-19

Comparison of diagnostic accuracy of rapid antigen tests for COVID19 compared to the viral genetic test in adults: a systematic review and meta-analysis

SARS-CoV-2 Rapid Antigen Test Based on a New Anti-Nucleocapsid Protein Monoclonal Antibody: Development and Real-Time Validation

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