Comparison of analytical sensitivity of the eight rapid antigen detection kits for detecting SARS-CoV-2 virus.
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ABSTRACT:
SUBMITTER: Mak GCK
PROVIDER: S-EPMC8486682 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has had a significant impact on global public health systems, making nucleic acid detection an important tool in epidemic prevention and control. Detection kits based on real-time reverse transcriptase PCR (rRT-PCR) have been used widely in clinics, but their analytical sensitivity (limit of detection, LOD) remains controversial. Moreover, there is limited research evaluating the analytical sensitivity of other molecular detection kits.MethodsIn this study, armored ribonucleic acid reference materials developed in-house were used to evaluate the analytical sensitivity of SARS-CoV-2 detection kits approved by the National Medical Products Administration. These were based on rRT-PCR and other molecular detection assays.ResultsThe percentage retesting required with rRT-PCR kits was as follows: 0%, 7.69%, 15.38%, and 23.08% for samples with concentrations ranging from 50 000 to 781 copies/ml. In total, 93% of rRT-PCR kits had a LOD <1000 copies/ml. Only one kit had an LOD >1000 copies/ml. The LOD of other molecular detection kits ranged from 68 to 2264 copies/ml.ConclusionsThe study findings can help pharmaceutical companies optimize and improve detection kits, guide laboratories in selecting kits, and assist medical workers in their daily work.
| S-EPMC8379823 | biostudies-literature
Project description:BackgroundNumerous rapid antigen detection (RAD) kits for diagnosing COVID-19 patients are available in the market recently.ObjectiveTo compare analytical sensitivity and clinical sensitivity for the three commercially available RAD kits.Study designAnalytical sensitivity for the detection of SARS-CoV-2 virus was determined by limit of detection (LOD) using RT-PCR as a reference method. Clinical sensitivity was evaluated by using respiratory specimens collected from confirmed COVID-19 patients.ResultsThe LOD results showed that the three RAD kits varied from 102-105 fold less sensitive than RT-PCR. Clinical sensitivity of RAD kits ranged from 22.9 %-71.4 % for detecting specimens from COVID-19 patients.ConclusionsAlthough RAD kits were less sensitive than RT-PCR, understanding the clinical characteristics of different RAD kits can guide us to obtain suitable specimens for testing. The likelihood of positive results for RAD kits will be higher.
| S-EPMC7598567 | biostudies-literature
Project description:Background Currently, there is a lack of studies evaluating rapid antigen detection (RAD) kits to detect SARS-CoV-2 B.1.1.529. Objective To evaluate the analytical sensitivity of seven RAD kits to detect SARS-CoV-2 B.1.1.529. Study design The analytical sensitivity was determined by means of limit of detection (LOD). A dilution set using a respiratory specimen collected from a COVID-19 patient infected with SARS-CoV-2 B.1.1.529 was prepared. RT-PCR was used as a reference method. Results The LOD results showed that all seven RAD kits had comparable analytical sensitivity for detection of SARS-CoV-2 B.1.1.529. Conclusions The RAD kits selected in the current study may be used for first-line screening of the recently emerged SARS-CoV-2 B.1.1.529.
| S-EPMC9153237 | biostudies-literature
Project description: Not available
| S-EPMC8612709 | biostudies-literature
Project description:Aim: Currently, there is lack of data regarding rapid antigen detection (RAD) kits to detect SARS-CoV-2 B.1.617.2 virus. Objective: The purpose of this evaluation is to assess analytical sensitivity of 12 RAD kits against SARS-CoV-2 B.1.617.2. Study design: Analytical sensitivity was determined by limit of detection (LOD). A serial tenfold dilution set from a respiratory specimen collected from a COVID-19 patient infected by SARS-CoV-2 B.1.617.2 was used. RT-PCR was used as a reference method. Results: The LOD results showed that 11 and one RAD kits were 100- and 1000-fold less sensitive than RT-PCR respectively. Conclusion: The results showed that the RAD kits evaluated in this study may be used for first-line screening of the SARS-CoV-2 B.1.617.2 variant.
| S-EPMC9006337 | biostudies-literature
Project description:Early diagnosis is still as crucial as the initial stage of the COVID-19 pandemic. As RT-PCR sometimes is not feasible in developing nations or rural areas, health professionals may use a rapid antigen test (RAT) to lessen the load of diagnosis. However, the efficacy of RAT is yet to be investigated thoroughly. Hence, we tried to evaluate the overall performance of RAT in SARS-CoV-2 diagnosis. Based on our PROSPERO registered protocol (CRD42021231432), we searched online databases (i.e., PubMed, Google Scholar, Scopus, and Web of Science) and analysed overall pooled specificity and sensitivity of RAT along with study quality, publication bias, heterogeneity and more. The overall pooled specificity and sensitivity of RAT were detected as 99.4% (95% CI: 99.1-99.8; I2 = 90%) and 68.4% (95% CI: 60.8-75.9; I2 = 98%), respectively. In subgroup analyses, nasopharyngeal specimens and symptomatic patient's samples were more sensitive in RAT, while cycle threshold (Ct) values were found to have an inverse relationship with sensitivity. In the European and American populations, RAT showed better performance. Although the sensitivity of RAT is yet to be improved, it could still be an alternative in places with poor laboratory set up. Nevertheless, the negative samples of RAT can be re-tested using RT-PCR to reduce false negative results.
| S-EPMC8397079 | biostudies-literature
Project description:Rapid Antigen Tests (RAT) have become an invaluable tool for combating the COVID-19 pandemic. However, concerns have been raised regarding the ability of existing RATs to effectively detect emerging SARS-CoV-2 variants. We compared the performance of eight commercially available, emergency use authorized RATs against the Delta and Omicron SARS-CoV-2 variants using individual patient and serially diluted pooled clinical samples. The RATs exhibited lower sensitivity for Omicron samples when using PCR Cycle threshold (C T ) value (a proxy for RNA concentration) as the comparator. Interestingly, however, they exhibited similar sensitivity for Omicron and Delta samples when using quantitative antigen concentration as the comparator. We further found that the Omicron samples had lower ratios of antigen to RNA, which offers a potential explanation for the apparent lower sensitivity of RATs for that variant when using C T value as a reference. Our findings underscore the complexity in assessing RAT performance against emerging variants and highlight the need for ongoing evaluation in the face of changing population immunity and virus evolution.
| S-EPMC9934810 | biostudies-literature
Project description:We investigated the infectivity of 128 severe acute respiratory disease coronavirus 2-associated deaths and evaluated predictive values of standard diagnostic procedures. Maintained infectivity (20%) did not correlate with viral RNA loads but correlated well with anti-S antibody levels. Sensitivity >90% for antigen-detecting rapid diagnostic tests supports their usefulness for assessment.
| S-EPMC8714232 | biostudies-literature
Project description:The antigen rapid diagnostic test (Ag-RDT) is a useful diagnostic tool for the detection and management of COVID-19 spread. Global SARS-CoV-2 variant outbreaks have highlighted the need for a test capable of detecting SARS-CoV-2 variants with high sensitivity and a low limit of detection. This study aimed to develop and evaluate, both analytically and clinically, an antigen rapid diagnostic test (the KestrelTM COVID-19 Ag Rapid Test) for professional use. A lateral flow immunoassay-based diagnostic test kit was developed, and various aspects of its analytical performance were evaluated. This test kit was clinically evaluated by two independent laboratories and showed closely related results of 96.49% and 98.33% of sensitivity, 100% and 100% of specificity, and 99.01% and 99.44% of accuracy, respectively. A limit of detection was observed at values as low as 0.156 ng/mL for recombinant SARS-CoV-2 nucleocapsid protein. Moreover, the test kit successfully detected the recombinant SARS-CoV-2 nucleocapsid protein (NP) of wild-type, Alpha-, Beta-, Gamma-, Delta-, Epsilon-, Kappa-, and Omicron-variants as positive results. Therefore, the KestrelTM COVID-19 Ag Rapid Test may have potential use for effective COVID-19 screening, surveillance, and infection control in a variety of global SARS-CoV-2 variant outbreaks.
| S-EPMC8871278 | biostudies-literature
Project description:BackgroundWe aimed at evaluating the diagnostic performance of rapid antigen test (RAT) compared to polymerase chain reaction (PCR) for severe acute respiratory syndrome coronavirus 2 and the possible transmission of infection to close contacts from patients with negative RAT and positive PCR results.Materials and methodsPatients/guardians urgently requiring admission to the ward on the same day had been hospitalized with RAT-negative result before the PCR results were available. We performed an epidemiologic investigation of the close contacts of those with negative RAT but positive PCR results after hospitalization.ResultsA total of 4,237 RATs were performed from March to August 2022. When the PCR test was used as the reference, RAT had a sensitivity of 28.8% (17/59; 95% confidence interval [CI], 17.8 - 42.1), a specificity of 100% (4,220/4,220; 95% CI, 99.9 - 100.0), a positive predictive value of 100.0% (17/17; 95% CI, 100.0 - 100.0), and a negative predictive value of 99.0% (4,178/4,220; 95% CI, 99.3 - 99.8). The epidemiologic investigation revealed that among the 32 patients with negative RAT and subsequent positive PCR results after admission into multi-patient room, two (6.3%) showed secondary coronavirus disease 2019.ConclusionThe secondary transmission rate from patients with negative RAT and positive PCR results was low. Our data suggest that RAT may be useful for rapid exclusion of high transmissible cases. However, further evaluation using whole genome sequencing is needed to determine the potential for transmissibility in cases showing a negative RAT but a positive PCR result.
| S-EPMC10990885 | biostudies-literature