Point-of-care evaluation of a rapid antigen test (CLINITESTⓇ Rapid COVID-19 Antigen Test) for diagnosis of SARS-CoV-2 infection in symptomatic and asymptomatic individuals.
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ABSTRACT:
SUBMITTER: Torres I
PROVIDER: S-EPMC7879056 | biostudies-literature | 2021 May
REPOSITORIES: biostudies-literature
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Point-of-care evaluation of a rapid antigen test (CLINITEST<sup>Ⓡ</sup> Rapid COVID-19 Antigen Test) for diagnosis of SARS-CoV-2 infection in symptomatic and asymptomatic individuals.
Torres Ignacio I Poujois Sandrine S Albert Eliseo E Álvarez Gabriela G Colomina Javier J Navarro David D
The Journal of infection 20210212 5
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Project description:BackgroundSARS-CoV-2 real-time reverse transcriptase polymerase chain reaction (qRT-PCR) is well suited for the diagnosis of clinically ill patients requiring treatment. Application for community testing of symptomatic individuals for disease control purposes however raises challenges. SARS-CoV-2 rapid antigen tests might offer an alternative, but quality evidence on their performance is limited.MethodsWe conducted an evaluation of the test accuracy of the 'BD Veritor System for Rapid Detection of SARS-CoV-2' (VRD) compared to qRT-PCR on combined nose/throat swabs obtained from symptomatic individuals at Municipal Health Service (MHS) COVID-19 test centers in the Netherlands. In part one of the study, with the primary objective to evaluate test sensitivity and specificity, all adults presenting at one MHS test center were eligible for inclusion. In part two, with the objective to evaluate test sensitivity stratified by Ct (cycle threshold)-value and time since symptom onset, adults who had a positive qRT-PCR obtained at a MHS test center were eligible.FindingsIn part one (n = 352) SARS-CoV-2 prevalence was 4.8%, overall specificity 100% (95%CI: 98·9%-100%) and sensitivity 94·1% (95%CI: 71·1%-100%). In part two (n = 123) the sensitivity was 78·9% (95%CI: 70·6%-85·7%) overall, 89·4% (95% CI: 79·4%-95·6%) for specimen obtained within seven days after symptom onset and 93% (95% CI: 86%-97.1%) for specimen with a Ct-value below 30.InterpretationThe VRD is a promising diagnostic for COVID-19 testing of symptomatic community-dwelling individuals within seven days after symptom onset in context of disease control. Further research on practical applicability and the optimal position within the testing landscape is needed.
| S-EPMC8118553 | biostudies-literature
Project description:BackgroundPerformance of the SD Biosensor saliva antigen rapid test was evaluated at a large designated testing site in non-hospitalized patients, with or without symptoms.MethodAll eligible people over 18 years of age presenting for a booked appointment at the designated SARS-CoV-2 testing site were approached for inclusion and enrolled following verbal informed consent. One nasopharyngeal swab was taken to carry out the default antigen rapid test from which the results were reported back to the patient and one saliva sample was self-taken according to verbal instruction on site. This was used for the saliva antigen rapid test, the RT-PCR and for virus culture. Sensitivity of the saliva antigen rapid test was analyzed in two ways: i, compared to saliva RT-PCR; and ii, compared to virus culture of the saliva samples. Study participants were also asked to fill in a short questionnaire stating age, sex, date of symptom onset. Recommended time of ≥30mins since last meal, drink or cigarette if applicable was also recorded. The study was carried out in February-March 2021 for 4 weeks.ResultsWe could include 789 people with complete records and results. Compared to saliva RT-PCR, overall sensitivity and specificity of the saliva antigen rapid test was 66.1% and 99.6% which increased to 88.6% with Ct ≤30 cutoff. Analysis by days post onset did not result in higher sensitivities because the large majority of people were in the very early phase of disease ie <3 days post onset. When breaking down the data for symptomatic and asymptomatic individuals, sensitivity ranged from 69.2% to 50% respectively, however the total number of RT-PCR positive asymptomatic participants was very low (n = 5). Importantly, almost all culture positive samples were detected by the rapid test.ConclusionOverall, the potential benefits of saliva antigen rapid test, could outweigh the lower sensitivity compared to nasopharyngeal antigen rapid test in a comprehensive testing strategy, especially for home/self-testing and in vulnerable populations like elderly, disabled or children where in intrusive testing is either not possible or causes unnecessary stress.
| S-EPMC8694432 | biostudies-literature
Project description:BackgroundThe 2013-2016 West African Ebola virus disease (EVD) epidemic is the largest recorded. Triage on the basis of clinical signs had limited success, and the time to diagnosis by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) could exceed 5 days. Here we describe the development and field validation of the ReEBOV Antigen Rapid Test (ReEBOV RDT) to aid triage of individuals with suspected EVD.MethodsSamples from patients with suspected EVD were submitted to Kenema Government Hospital, Sierra Leone, for Lassa fever and EVD screening throughout 2014. Banked residual clinical samples were tested in November 2014 and January 2015 in a blinded field trial to estimate the clinical effectiveness of the ReEBOV RDT, compared with EBOV-specific qRT-PCR.ResultsPreliminary ReEBOV RDT performance demonstrated a positive percentage agreement (PPA) of 91.1% (195 of 214 results; 95% confidence interval [CI], 86.5%-94.6%) and a negative percentage agreement (NPA) of 90.2% (175 of 194; 95% CI, 85.1%-94.0%). The final estimates used by the Food and Drug Administration to determine whether to grant emergency use authorization for the test, which excluded a qRT-PCR reference method threshold cutoff, were a PPA of 62.1% (72 of 116 results; 95% CI, 52.6%-70.9%) and a NPA of 96.7% (58 of 60; 95% CI, 88.5%-99.6%), with a diagnostic likelihood of 18.6. A subsequent, independent evaluation by the World Health Organization generated results consistent with the preliminary performance estimates.ConclusionsThe ReEBOV RDT demonstrated the potential to provide clinically effective rapid and accurate point-of-care test results and, thus, to be a powerful tool for increasing triage efficiency.
| S-EPMC5050478 | biostudies-literature
Project description:BackgroundEbola virus disease (EVD) is a severe viral illness caused by Ebola virus (EBOV). The 2013-2016 EVD outbreak in West Africa is the largest recorded, with >11 000 deaths. Development of the ReEBOV Antigen Rapid Test (ReEBOV RDT) was expedited to provide a point-of-care test for suspected EVD cases.MethodsRecombinant EBOV viral protein 40 antigen was used to derive polyclonal antibodies for RDT and enzyme-linked immunosorbent assay development. ReEBOV RDT limits of detection (LOD), specificity, and interference were analytically validated on the basis of Food and Drug Administration (FDA) guidance.ResultsThe ReEBOV RDT specificity estimate was 95% for donor serum panels and 97% for donor whole-blood specimens. The RDT demonstrated sensitivity to 3 species of Ebolavirus (Zaire ebolavirus, Sudan ebolavirus, and Bundibugyo ebolavirus) associated with human disease, with no cross-reactivity by pathogens associated with non-EBOV febrile illness, including malaria parasites. Interference testing exhibited no reactivity by medications in common use. The LOD for antigen was 4.7 ng/test in serum and 9.4 ng/test in whole blood. Quantitative reverse transcription-polymerase chain reaction testing of nonhuman primate samples determined the range to be equivalent to 3.0 × 105-9.0 × 108 genomes/mL.ConclusionsThe analytical validation presented here contributed to the ReEBOV RDT being the first antigen-based assay to receive FDA and World Health Organization emergency use authorization for this EVD outbreak, in February 2015.
| S-EPMC5050482 | biostudies-literature
Project description:Although the nasopharyngeal swab (NPS) is considered the gold standard for the diagnosis of the SARS-CoV-2 infection, the Nasal Mid-Turbinate swab (NMTS) is often used due to its higher tolerance among patients. We compared the diagnostic performance of the NPS and the NMTS for the Panbio™ COVID-19 antigen-detecting rapid diagnostic test (Ag-RDT). Two hundred and forty-three individuals were swabbed three times by healthcare professionals: a NMTS and a NPS specimen for the Ag-RDT and an oropharyngeal swab for real time RT-PCR. Forty-nine participants were RNA-SARS-CoV-2 positive by real time RT-PCR: 45 and 40 were positive by the Ag-RDT with NPS and NMTS, respectively. The overall sensitivity and specificity were 91.8% (95% CI: 83.2-100.0) and 99.5% (95% CI: 98.2-100.0) for Ag-RDT with NPS, and 81.6% (95% CI: 69.8-93.5) and 100.0% (95% CI: 99.7-100.0) for the Ag-RDT with NMTS. The Cohen's kappa index was 0.92 (95% CI: 0.85-0.98). Among asymptomatic individuals, the Ag-RDT with both sampling techniques showed a high sensitivity [100.0% (95% CI: 95.5-100.0) with NPS; 90.9% (95% CI: 69.4-100.0) with NMTS], while the performance of the test decreased in samples with Ct≥ 30 and in patients tested after the first 7 days from symptom onset. Although the NMTS yielded a lower sensitivity compared to NPS, it might be considered a reliable alternative, as it presents greater adherence among patients, enabling scaling of antigen testing strategies, particularly in countries with under-resourced health systems.
| S-EPMC8986327 | biostudies-literature
Project description:PurposeReal time reverse transcriptase PCR (rRT PCR) although gold standard test for the diagnosis of SARS CoV-2, carries disadvantages of a sophisticated set up, long time to results and centralized services. The rapid antigen tests (RAT) can be used as a primary screening tool with the advantages of rapid turnaround time and ease of use. The study was conducted to determine the performance of rapid antigen test (standard Q COVID 19 Ag) in comparison to rRT PCR in symptomatic patients and asymptomatic contacts and asymptomatic patients with no apparent contact history.MethodsNasopharyngeal swabs taken in duplicate from 1034 patients were collected over a 5 months period. These included 248 (23.98%) symptomatic, 386 (37.34%) asymptomatic contacts and 400 (38.68%) asymptomatic subjects who were routinely screened in pre-operative period, as a prerequisite for travel, or pregnant females. Both rRT PCR and RAT were performed as per manufacturers' instructions. Performance of test in different subgroups of patients was evaluated. Performance of RAT test on basis of duration of illness and Ct values was also analyzed.ResultsIn this study, 445 (43.04%) were rRT PCR positive, out of which 374 samples were RAT positive as well. 31 samples were RAT positive but PCR negative. The sensitivity, specificity, PPV and NPV of the rapid antigen test was 84.04%, 94.74%, 92.35% and 88.71% respectively. The negative predictive value of the test in asymptomatic patients without any significant contact history was 97.07%.ConclusionsThis study recommends the use of the antigen test as a method of diagnosis for SARS CoV-2. However a negative result with RAT in suspected patients and their contacts should be viewed with caution. This study also finds the utility of using RAT test in the community settings as a screening test in schools, colleges and mass gatherings.
| S-EPMC9249411 | biostudies-literature
Project description:ObjectivesThe aim of this study was to determine the relative infectiousness of asymptomatic SARS-CoV-2 infected persons compared with symptomatic individuals based on a scoping review of available literature.DesignRapid scoping review of peer-reviewed literature from 1 January to 5 December 2020 using the LitCovid database and the Cochrane library.SettingInternational studies on the infectiousness of individuals infected with SARS-CoV-2.ParticipantsStudies were selected for inclusion if they defined asymptomatics as a separate cohort distinct from presymptomatics and if they provided a quantitative measure of the infectiousness of asymptomatics relative to symptomatics.Primary outcome measuresPCR result (PCR studies), the rate of infection (mathematical modelling studies) and secondary attack rate (contact tracing studies) - in each case from asymptomatic in comparison with symptomatic individuals.ResultsThere are only a limited number of published studies that report estimates of relative infectiousness of asymptomatic compared with symptomatic individuals. 12 studies were included after the screening process. Significant differences exist in the definition of infectiousness. PCR studies in general show no difference in shedding levels between symptomatic and asymptomatic individuals; however, the number of study subjects is generally limited. Two modelling studies estimate relative infectiousness to be 0.43 and 0.57, but both of these were more reflective of the infectiousness of undocumented rather than asymptomatic cases. The results from contact tracing studies include estimates of relative infectiousness of 0, but with insufficient evidence to conclude that it is significantly different from 1.ConclusionsThere is considerable heterogeneity in estimates of relative infectiousness highlighting the need for further investigation of this important parameter. It is not possible to provide any conclusive estimate of relative infectiousness, as the estimates from the reviewed studies varied between 0 and 1.
| S-EPMC8098293 | biostudies-literature
Project description:BackgroundPlasmodium infection among children is a serious public health problem. Asymptomatic malaria infection among humans serves as a significant reservoir for transmitting Plasmodium to uninfected Anopheles mosquitoes, fueling malaria endemicity and asymptomatic malaria may progress to clinical malaria. Therefore, prompt and accurate diagnosis of malaria infection is crucial for the management and control of malaria, especially in endemic areas. This study assessed the point prevalence of asymptomatic malaria infection and evaluated the performance of malaria Rapid Diagnostic Tests (RDT), light microscopy and nested PCR (nPCR) for the diagnosis of asymptomatic malaria infection in a paediatric population in the Atwima Nwabiagya North district, Ghana.MethodsThis cross-sectional study enrolled 500 asymptomatic children aged ≤ 5 years. After consent was obtained from a parent, blood samples were collected from each participant to assess for Plasmodium infection based on histidine rich protein-2 (pfHRP-2)-based malaria RDT, light microscopy and nPCR.ResultsThe point prevalence of asymptomatic malaria by microscopy, RDT, and nPCR were 116/500 (23.2%), 156/500 (31.2%), and 184/500 (36.8%), respectively. Using nPCR as the reference, RDT presented with a perfect sensitivity (100.0%), specificity (100.0%), accuracy (100.0%), and reliability (100.0%) in detecting asymptomatic P. falciparum infection. Likewise, microscopy presented with an excellent specificity and high accuracy in detecting both P. falciparum (100.0%; 85.6%) and P. malariae (100.0%; 100.0%). However, the sensitivity (56.4%) and reliability (56.4%) of microscopy was low for both P. falciparum.ConclusionThe findings of this study indicate a high point prevalence of asymptomatic Plasmodium infection among children in Atwima Nwabiagya North district, Ghana. In the absence of the more sensitive PCR, pfHRP-2-based malaria RDT provides substantial diagnostic sensitivity, specificity, accuracy and reliability and is superior to microscopy.
| S-EPMC7384639 | biostudies-literature
Project description: Not available
| S-EPMC9305720 | biostudies-literature
Project description:Molecular tests are the gold standard to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but are associated with a diagnostic delay, while antigen detection tests can generate results within 20 min even outside a laboratory. In order to evaluate the accuracy and reliability of the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit (Ag-RDT), two respiratory swabs were collected simultaneously from 501 patients, with mild or no coronavirus disease 2019 (COVID-19)-related symptoms, and analyzed with both the Reverse Transcriptase-quantitative Polymerase Chain Reaction (RT-qPCR) and the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test. Results were then compared to determine clinical performance in a screening setting. We measured a precision of 97.41% (95% CI 92.42-99.15%) and a recall of 98.26% (95% CI 93.88-99.25%), with a specificity of 99.22% (95% CI 97.74-99.74%), a negative predictive value of 99.48% (95% CI 97.98-99.87%), and an overall accuracy of 99.00% (95% CI 97.69-99.68%). Concordance was described by a Kappa coefficient of 0.971 (95% CI 0.947-0.996). Considering short lead times, low cost, and opportunities for decentralized testing, the Ag-RDT test can enhance the efforts to control SARS-CoV-2 spread in several settings.
| S-EPMC8947527 | biostudies-literature