Rapid RT-PCR Research Articles

A retrospective cohort study of the effect of SARS-CoV-2 point of care rapid RT-PCR at the Emergency Department on targeted admission

BackgroundTo prevent nosocomial transmission of SARS-CoV-2, infection prevention control (IPC) measures are implemented for patients with symptoms compatible with COVID-19 until reliable test results are available. This delays admission to the most appropriate ward based on the medical condition. SARS-CoV-2 rapid antigen detection (RAD) tests and point-of-care (POC) rapid RT-PCR (VitaPCR) were introduced at emergency department (ED) at Skåne University Hospital, Sweden in late 2020, but the consequence on patient flow and targeted admission is unknown.MethodsPatients presenting at the emergency department of a referral hospital (N = 2940) between 13-Nov-2020 and 12-Jan-2021 were included. The study period was delimited into three periods by the introduction of RAD tests and the VitaPCR. Participant data was collected from hospital records, and outcome variables were Length-of-Stay (LoS), intrahospital transfers and targeted admission to COVID-19 ward.ResultsCompared to baseline (RT-PCR only), RAD tests reduced ED Length-of-Stay (LoS) for participants with positive tests. Negative VitaPCR results reduced mean hospital LoS by 1.5 (95% CI 0.3–2.7) days and admissions to COVID-19 wards from 34.5 (95% CI 28.9–40.5) to 14.7 (95% CI 11.1–19.1) per 100 admissions and reduced transfers between hospital wards in the first 5 days from 50.0 (95% CI 45.0–55.0) to 34.0 (95% CI 30.3–37.9) per 100 admissions.ConclusionRAD tests enabled prompt detection of SARS-CoV-2 infection which had pronounced effects on LoS at the ED. Negative VitaPCR enabled cessation of IPC measures and a negative test was associated with increased targeted admissions, reduced intrahospital transfers and shorter LoS at the hospital.

Prospective open pilot study on the use of cam oleum ointment for feline calicivirus disease in cats in Baghdad City

Feline calicivirus (FCV) is a highly contagious virus that causes a mild to severe respiratory infection and oral disease in cats. It is especially common in shelters and breeding colonies, and often infects young cats, this study contained 50 different cats and samples were collected from September 2020 to January 2021. Samples taken by swabs from oropharyngeal and conjunctival area depending on the lesion of FCV infection to investigate viral nucleic acid from collected swabs, then extracting RNA from the swabs and converting it to a cDNA molecule, and last detecting the open reading template gene 2 using specific primer, these samples isolated from veterinary clinics, and shelters, all samples were collected from Baghdad city .Rapid test AG kit and Real time PCR were done to confirm the detection and the results gave us 28 positive results on rapid AG kit and RT-PCR results gave us 32 positive samples and the other 18 samples gave us negative results by detection with nanodrop device before sending all samples for molecular investigation by polymerase chain reaction. Most cats recover completely after a calicivirus infection when we treated with Camoleum ointmentprepared in veterinary medicine college lab.

COVID-19 Diagnosis: A Review of Rapid Antigen, RT-PCR and Artificial Intelligence Methods.

As of 27 December 2021, SARS-CoV-2 has infected over 278 million persons and caused 5.3 million deaths. Since the outbreak of COVID-19, different methods, from medical to artificial intelligence, have been used for its detection, diagnosis, and surveillance. Meanwhile, fast and efficient point-of-care (POC) testing and self-testing kits have become necessary in the fight against COVID-19 and to assist healthcare personnel and governments curb the spread of the virus. This paper presents a review of the various types of COVID-19 detection methods, diagnostic technologies, and surveillance approaches that have been used or proposed. The review provided in this article should be beneficial to researchers in this field and health policymakers at large.

Correlation of Rapid Antibody and RT-PCR Tests With Clinical and Radiological Findings in COVID-19 Patients Admitted to an Employee Health Outpatient Clinic

Correlation of Rapid Antibody and RT-PCR Tests With Clinical and Radiological Findings in COVID-19 Patients Admitted to an Employee Health Outpatient Clinic

Performance of Rapid Antibody Test and RT-PCR as Frontline Test for COVID-19 Diagnosis in Pregnancy: an Experience in Indonesia

Ensuring an accurate diagnosis is critical for limiting the spread of SARS-CoV-2 and for the clinical management of COVID-19, especially in pregnant women. For now real-time reverse transcription polymerase chain reaction (RT-qPCR) is the currently recommended laboratory method for the diagnosis of acute SARS-CoV-2 infection. More recently, several easy-to-perform rapid antigen detection tests have been developed and are recommended as first-line screening test in several countries. The purpose of this study was to evaluate the comparative performance of a rapid antibody test and RT-PCR for the detection of SARS-CoV-2 infection, as a front-line test for the diagnosis of COVID-19 in pregnancy. This research method is a descriptive study to describe comparation of sensitivity and specificity between rapid SARS-CoV-2 antibody test to the gold standard nasopharyngeal RT-PCR swab test. Of the 271 samples, only 257 were eligible and fourteen cases were excluded from the study due to a lack of rapid antibody test and RT-PCR results. The results of this study showed that the rapid SARS-CoV-2 antibody test sensitivity was 80.95%, and the specificity was 90.68%, the NPV (negative predictive value) and the PPV (positive prognosis value) were 98.17% and 43.59%, respectively. Based only on the results of IgM and IgG, IgM and IgG sensitivity were 33.33% (7/21) and 71.43% (15/21), respectively, and the specificity was 91.1% (215/236, 21 false positive) and 91.53% (216/236, 20 false positive), respectively. The use of rapid antibody tests during pregnancy is a screening tool and is not currently applicable for diagnostic tool. To minimize false positives and negatives results, the use of rapid antibody tests should be combined with the RT-PCR test results.

Performance of Rapid Antibody Test and RT-PCR as Frontline Test for COVID-19 Diagnosis in Pregnancy: an Experience in Indonesia

Ensuring an accurate diagnosis is critical for limiting the spread of SARS-CoV-2 and for the clinical management of COVID-19, especially in pregnant women. For now real-time reverse transcription polymerase chain reaction (RT-qPCR) is the currently recommended laboratory method for the diagnosis of acute SARS-CoV-2 infection. More recently, several easy-to-perform rapid antigen detection tests have been developed and are recommended as first-line screening test in several countries. The purpose of this study was to evaluate the comparative performance of a rapid antibody test and RT-PCR for the detection of SARS-CoV-2 infection, as a front-line test for the diagnosis of COVID-19 in pregnancy. This research method is a descriptive study to describe comparation of sensitivity and specificity between rapid SARS-CoV-2 antibody test to the gold standard nasopharyngeal RT-PCR swab test. Of the 271 samples, only 257 were eligible and fourteen cases were excluded from the study due to a lack of rapid antibody test and RT-PCR results. The results of this study showed that the rapid SARS-CoV-2 antibody test sensitivity was 80.95%, and the specificity was 90.68%, the NPV (negative predictive value) and the PPV (positive prognosis value) were 98.17% and 43.59%, respectively. Based only on the results of IgM and IgG, IgM and IgG sensitivity were 33.33% (7/21) and 71.43% (15/21), respectively, and the specificity was 91.1% (215/236, 21 false positive) and 91.53% (216/236, 20 false positive), respectively. The use of rapid antibody tests during pregnancy is a screening tool and is not currently applicable for diagnostic tool. To minimize false positives and negatives results, the use of rapid antibody tests should be combined with the RT-PCR test results.

Rationale of using SARS-CoV-2 Rapid Antigen Test as a Point of care device in resource poor clinical set up: A comparative study in a peripheral health set up to meet up pandemic needs

COVID-19 testing with RT-PCR may result in late detection of disease. Rapid Antigen Detection Test is much faster, easy to perform and suitable for population wise testing strategies. Our study assesses the diagnostic accuracy of Rapid Antigen Test (RAT) compared to RT-PCR in peripheral health care set up. The study was aimed to detect the diagnostic accuracy of the COVID-19 antigen test such as to understand its position as a point of care device in a resource poor clinical set up during a rapidly spreading and high mortality ridden pandemic. In this study we compared SARS-CoV2 rapid antigen test and RT-PCR by considering that RT-PCR is the gold standard test in a rapidly arranged molecular diagnostic lab. We analyzed total 389 samples who have undergone both rapid antigen test and RT-PCR. The correlation between Ct values in RT-PCR test and RAT positivity was analyzed. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy were found to be 75.47% (61.72-86.24%), 92.26% (88.87-94.88%), 33.92% (25.60-43.36%), 98.62% (97.8-99.14%) and 91.42% (88.19-94.19%), respectively. The k-coefficient of agreement between RAT and RTPCR was 0.615 ± 0.056 (0.504-0.724). For specimens with Ct value < 20, 20-25, 26-30, 30-35 and >35 were 100%, 90.3%, 80.3%, 60% for Ct value and 25% respectively. Our results suggest that RAT may be considered as an alternative to RT-PCR testing in peripheral health care set up. We reveal the importance of implementing rapid antigen test properly combined with clinical assessment of symptomatic patients so that it can be used in primary health care where RT-PCR testing facility is not available.

The Diagnostic Accuracy of SARS-CoV-2 Rapid Antibody Tests among Asymptomatic Employees Returning to Work During General Community Quarantine Period (June 1 to July 31, 2020)

Objectives. The study was done to determine the diagnostic accuracy of rapid antibody tests (RATs) in detecting SARS-CoV-2 infection among asymptomatic employees returning to work. The study also aimed to determine the prevalence of asymptomatic RT-PCR-confirmed COVID-19 infection among these workers. Methods. The study was a retrospective cohort of asymptomatic employees involved in the manufacturing, marketing, and sales of pharmaceutical, consumer, and animal products in the Philippines. They underwent screening for COVID-19 using both rapid antibody and RT-PCR tests as part of the return-to-work company policy from June 1 to July 31, 2020. The sensitivity and specificity of the RATs were computed using RT-PCR as the reference standard. The prevalence of RT-PCR positive COVID-19 infections among asymptomatic returning workers was also determined. Results. Asymptomatic workers (n=5,585) were simultaneously tested for COVID-19 using RAT and RT-PCR. The sensitivity of a positive IgG and IgM was 23.9 (95% CI: 22.8 – 25.0), while the specificity was 93.3 (95% CI: 92.6 - 93.9). The prevalence of RT-PCR identified COVID-19 infection among asymptomatic workers was 4.9% (95% CI: 4.4 – 5.5). Conclusion. The utility of RATs as a screening tool to detect asymptomatic COVID-19 individuals is limited due to its low sensitivity compared to RT-PCR.

Validation of Microchip Based RT-PCR ABC Test (InfA/B & COVID-19) in Clinical Samples

To contain the rapid and global spread of SARS-CoV-2, it is essential to develop an accurate and sensitive test system to address pandemic bottlenecks, simplified sample collection, and no sample prep. While meeting the demand of testing large populations, the miniaturized volume of assay reagents and offering rapid results is the need in such scenarios. Moreover, in view of the reports of co-infections and overlapping symptoms of influenza caused by Influenza A or Influenza B, and COVID-19 caused by SARS-CoV-2, a test system with three targets can be supportive for accurate clinical diagnosis. In this presentation, we evaluated the performance of a test comprising Microchip RT-PCR Influenza and COVID-19 Detection System for identifying these three viral pathogens in nasal swabs and saliva specimens. A rapid and simplified total nucleic acid extraction method was developed and validated for the reliable, high-throughput simultaneous detection of respiratory viruses causing Influenza (type A and type B viruses) and COVID-19 (SARS-CoV-2 virus) using the microchip-based AriaDNATM platform deriving the name ABC Test. The test system was evaluated using 81 nasal swab samples, 77 clinical saliva samples, 5 blind CAP reference samples, and RNA standards. The limit of detection (LoD) was assessed using SARS-CoV-2, Influenza A, and Influenza B RNA standards. The multiplex ABC Test microchip displayed LoD of 14 copies/μL for SARS-CoV-2 and approximately 26 copies/μL for influenza A, and 140 copies/μL for influenza B, respectively. The ABC Test offers rapid multiplex one-step RT-PCR in 32 minutes for 45 cycles as the miniaturized reaction of 1.2 μL offering a highly sensitive, robust, and accurate assay for the detection of influenza A/B, and SARS-CoV-2.

Effect of SARS-CoV-2 on glycemic control in post-COVID-19 diabetic patients.

To study the clinicodemographic profile, outcomes, and post-COVID change in glycemic control among treated COVID-19-infected patients with poorly controlled or well-controlled diabetes mellitus (DM). Adult COVID-19-infected patients who tested positive with rapid antigen test or RT-PCR admitted were included in this prospective observational study. Patients were divided into well-controlled and poorly controlled diabetes group based on HbA1c values at admission. Telephonic follow-up and HbA1c estimation was done after three months. Clinical and laboratory investigations performed were compared between both groups. Hazard ratios (HRs) for mortality risk in both well-controlled and poorly controlled COVID-19 patients with DM was done by Cox proportional hazard models. Out of 260 patients, 140 (53.84%) and 120 (46.15%) were poorly and well-controlled diabetics respectively. One hundred sixty-three patients (62.69%) were male, and the mean age was 52.67 ± 15.69 years. Severity, duration of hospital stay, steroid duration, insulin requirement and mean HbA1C, both at admission and after three months, were significantly higher in poorly controlled group than the well-controlled group (P < 0.005). With increase in age, the HR for all-cause mortality increased by 1.15 times (95% CI, 1.05-1.25; P = 0.0025) in well-controlled than poorly controlled group, whereas with increase in FBS at admission, the HR for all-cause mortality increased by 1.03 times in poorly controlled than well-controlled group (95% CI, 1.01-1.06; P = 0.0044). Our results show that well-controlled blood glucose levels or improved glycemic control are associated with a better outcome in patients with COVID-19 and pre-existing type 2 diabetes mellitus.

Rapid antigen test to identify COVID-19 infected patients with and without symptoms admitted to the Emergency Department.

PurposeEarly detection of SARS-CoV-2 patients is essential to contain the pandemic and keep the hospital secure. The rapid antigen test seems to be a quick and easy diagnostic test to identify patients infected with SARS-CoV-2. To assess the possible role of the antigen test in the Emergency Department (ED) assessment of potential SARS-CoV-2 infection in both symptomatic and asymptomatic patients.MethodsBetween 1 July 2020 and 10 December 2020, all patients consecutively assessed in the ED for suspected COVID-19 symptoms or who required hospitalisation for a condition not associated with COVID-19 were subjected to a rapid antigen test and RT-PCR swab. The diagnostic accuracy of the antigen test was determined in comparison to the SARS-CoV-2 PCR test using contingency tables. The possible clinical benefit of the antigen test was globally evaluated through decision curve analysis (DCA).ResultsA total of 3899 patients were subjected to antigen tests and PCR swabs. The sensitivity, specificity and accuracy of the antigen test were 82.9%, 99.1% and 97.4% (Cohen's K = 0.854, 95% CI 0.826–0.882, p < 0.001), respectively. In symptomatic patients, sensitivity was found to be 89.8%, while in asymptomatic patients, sensitivity was 63.1%. DCA appears to confirm a net clinical benefit for the preliminary use of antigen tests.ConclusionsThe antigen test performed in the ED, though not ideal, can improve the overall identification of infected patients. While it appears to perform well in symptomatic patients, in asymptomatic patients, although it improves their management, it seems not to be definitive.

Evaluation of Efficacy of Rapid Antigen Test against RT-PCR and its Correlation with Cycle Threshold (CT) values: an Institutional Experience

Rapidly increasing COVID-19 or SARS-CoV-2 in whole world caused a tremendous pressure on existing diagnostic setup to give accurate diagnosis on time by gold standard RT-PCR technique forcing scientist to think beyond RT-PCR which ultimately ended with invent of Rapid antigen test which can give about 100% specific and rapid result but may miss many case due to low sensitivity. So we wanted to evaluate the Rapid antigen test against RT-PCR for its diagnostic accuracy. We followed standard procedure for sample collection, Rapid antigen test and RT-PCR test. In about one and half month span we collected 554 antigen negative samples in our hospital. About 13% sample (74/554) turned out as positive by RT-PCR test. About 40 % (30/74) positive samples had low Ct value (&lt;25) indicating higher viral load present in those patients. Above findings indicate that only antigen test will miss a significant portion of positive cases with higher viral load which may complicate the pandemic by unknowingly spreading the virus within the society. So we should try to improve our infrastructure to carry out more RTPCR test so we can detect more cases to identify and isolate them from others to prevent or slowdown the transmission chain.

Assessing a chip based rapid RTPCR test for SARS CoV-2 detection (TrueNat assay): A diagnostic accuracy study.

COVID-19 testing is required before admission of a patient in the hospitals, invasive procedures, major and minor surgeries etc. Real Time Polymerase chain reaction is the gold standard test for the diagnosis, but requires well equipped biosafety laboratory along with trained manpower. In this study we have evaluated the diagnostic accuracy of novel TrueNat molecular assay for detecting SARS CoV-2. TrueNat is a chip-based real time PCR test and works on portable, light weight, battery powered equipment and can be used in remote areas with poor infrastructure. In this study 1807 patients samples were collected for both TrueNat and RTPCR COVID-19 testing during study period. Of these 174 (9.7%) and 174 (15%) were positive by RTPCR and TrueNat respectively and taking results of RTPCR as gold standard TrueNat test showed a sensitivity, specificity and diagnostic accuracy of 69.5, 90.9% and 89.2% respectively. It can be concluded that TrueNat is a simple, easy to use, good rapid molecular diagnostic test for diagnosis of COVID-19 especially in resource limited settings and will prove to be a game changer of molecular diagnostics in future.

A comparison of antigen-based rapid test and RT-PCR test to diagnose COVID-19 and its infectivity

Background. Medical screening and diagnostic cost and equipment availability has been a major obstacle to supposed-to-be extensive tracing, and overall, to the end of COVID-19 pandemic. Even though RT-PCR is the gold diagnostic standard, it is costly, lengthy, and may be unavailable in remote areas. Therefore, antigen-based COVID-19 rapid tests may be a solution to quickly detect and screen communities suspected of contracting COVID-19. Objective. This paper aims to observe how reliable antigen-based COVID-19 rapid tests are compared to RT-PCR testing. Material and methods. An observational cross-sectional study was performed on 101 samples to find the specificity, sensitivity, and accuracy of antigen-based rapid testing compared to RT-PCR testing performed on every individual. Then, a pattern between CT values and duration between onset of symptoms and testing to antigen-based rapid test result was observed to find a cut-off value such that the person may be deemed safe to exit isolation. Outcomes. A cut-off CT value of above 30.04 (p &lt; 0.01) with a sensitivity of 66.7% and specificity of 77.8% (moderate accuracy) obtained from ROC analysis showed negative results on antigen-based rapid tests. The tests showed an overall accuracy of 67.3%, where results between the two tests were consistent. Conclusion. Therefore, an estimated CT value of 30 was moderately proved to be used as a criterion to end isolation and presume the person no longer sheds SARS-CoV-2.

Sensitivity of Rapid Antigen Testing and RT-PCR Performed on Nasopharyngeal Swabs versus Saliva Samples in COVID-19 Hospitalized Patients: Results of a Prospective Comparative Trial (RESTART).

Saliva sampling could serve as an alternative non-invasive sample for SARS-CoV-2 diagnosis while rapid antigen tests (RATs) might help to mitigate the shortage of reagents sporadically encountered with RT-PCR. Thus, in the RESTART study we compared antigen and RT-PCR testing methods on nasopharyngeal (NP) swabs and salivary samples. We conducted a prospective observational study among COVID-19 hospitalized patients between 10 December 2020 and 1 February 2021. Paired saliva and NP samples were investigated by RT-PCR (Cobas 6800, Roche-Switzerland, Basel, Switzerland) and by two rapid antigen tests: One Step Immunoassay Exdia® COVID-19 Ag (Precision Biosensor, Daejeon, Korea) and Standard Q® COVID-19 Rapid Antigen Test (Roche-Switzerland). A total of 58 paired NP-saliva specimens were collected. A total of 32 of 58 (55%) patients were hospitalized in the intensive care unit, and the median duration of symptoms was 11 days (IQR 5-19). NP and salivary RT-PCR exhibited sensitivity of 98% and 69% respectively, whereas the specificity of these RT-PCRs assays was 100%. The NP RATs exhibited much lower diagnostic performance, with sensitivities of 35% and 41% for the Standard Q® and Exdia® assays, respectively, when a wet-swab approach was used (i.e., when the swab was diluted in the viral transport medium (VTM) before testing). The sensitivity of the dry-swab approach was slightly better (47%). These antigen tests exhibited very low sensitivity (4% and 8%) when applied to salivary swabs. Nasopharyngeal RT-PCR is the most accurate test for COVID-19 diagnosis in hospitalized patients. RT-PCR on salivary samples may be used when nasopharyngeal swabs are contraindicated. RATs are not appropriate for hospitalized patients.

Implementation of Sample Pooling Procedure Using a Rapid SARS-CoV-2 Diagnostic Real-Time PCR Test Performed Prior to Hospital Admission of People with Intellectual Disabilities.

Reliability, accuracy, and timeliness of diagnostic testing for SARS-CoV-2 infection have allowed adequate public health management of the disease, thus notably helping the timely mapping of viral spread within the community. Furthermore, the most vulnerable populations, such as people with intellectual disability and dementia, represent a high-risk group across multiple dimensions, including a higher prevalence of pre-existing conditions, lower health maintenance, and a propensity for rapid community spread. This led to an urgent need for reliable in-house rapid testing to be performed prior to hospital admission. In the present study, we describe a pooling procedure in which oropharyngeal and nasopharyngeal swabs for SARS-CoV-2 detection (performed prior to hospital admission using rapid RT-PCR assay) are pooled together at the time of sample collection. Sample pooling (groups of 2–4 samples per tube) allowed us to significantly reduce response times, consumables, and personnel costs while maintaining the same test sensitivity.

Efficacy Outcomes on morbidity and mortality of Intravenous Bolus Artesunate Therapy among Rapid Antigen Test and RT-PCR Negative Hospitalized Moderate to Severe Clinically Proven COVID-19 Patients: A Breakthrough large case series

Efficacy Outcomes on morbidity and mortality of Intravenous Bolus Artesunate Therapy among Rapid Antigen Test and RT-PCR Negative Hospitalized Moderate to Severe Clinically Proven COVID-19 Patients: A Breakthrough large case series

Extraction-Free Rapid Cycle Quantitative RT-PCR and Extreme RT-PCR for SARS-CoV-2 Virus Detection

Since the start of the coronavirus disease 2019 (COVID-19) pandemic, molecular diagnostic testing for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has faced substantial supply chain shortages and noteworthy delays in result reporting after sample collection. Supply chain shortages have been most evident in reagents for RNA extraction and rapid diagnostic testing. This study explored the kinetic limitations of extraction-free rapid cycle quantitative real-time RT-PCR for SARS-CoV-2 virus detection using the commercially available capillary-based LightCycler. After optimizing for time and reaction conditions, a protocol for sensitive and specific quantitative RT-PCR of SARS-CoV-2 RNA from nasopharyngeal swabs in <20 minutes was developed, with minimal hands-on time requirements. This protocol improves detection speed while maintaining the sensitivity and specificity of hydrolysis probe-based detection. Percentage agreement between the developed assay and previously tested positive patient samples was 97.6% (n = 40/41), and negative patient samples was 100% (40/40). The study further demonstrates that using purified RNA, SARS-CoV-2 testing using extreme RT-PCR, and product verification by melting can be completed in <3 minutes. Overall, these studies provide a framework for increasing the speed of SARS-CoV-2 and other infectious disease testing.

"The effectiveness of rapid antigen test-based for SARS-CoV-2 detection in nursing homes in Valencia, Spain".

The usefulness of the PANBIO ™ COVID-19 Ag rapid test for SARS-CoV-2 infection detection has not been widely studied, especially in specific population groups such as the elderly who are institutionalized. Rapid diagnostic tests have the potential to benefit testing strategies, as they have short turnaround times, they are cheap, simple to perform and can be used in decentralized testing. The objective of this study is to show the performance of the PANBIO™ COVID-19 Ag Rapid test device conducted at geriatric institutions and to compare results to those obtained from RT-PCR. A total of 448 individuals were enrolled in the study, including both residents and employees. Nasopharyngeal swabs were collected for both PANBIO™ COVID-19 Ag Rapid test and RT-PCR testing. All the samples were analyzed by specialized microbiologists. A total of 117 out of 448 individuals (26%) tested positive by RT-PCR, of whom 99 (85%) returned positive Antigen test results. There were 18 Antigen negative cases with positive RT-PCR results. Accordingly, concordance between RT-PCR and Antigen test results was acceptable (K index, 0.89; 95% IC 0.8455–0.9345). Overall sensitivity and specificity of Antigen test was 85% and 100%, respectively. When defining RT-PCR CT positivity on a cut-off value of 35, LFA sensitivity was 90%. In case a cut-off value of 30 was used, LFA would increase up to 99%. In this real-life evaluation of the PANBIO™ COVID-Ag rapid test, the assay reliably identified SARS-CoV-2 infected individuals with low CT-values by RT-PCR. False negative results were observed only at high CT-values, meaning low viral loads in nasopharyngeal samples.

Evaluation of the Abbott PanbioTM COVID-19 Ag rapid antigen test for the detection of SARS-CoV-2 in asymptomatic Canadians

Several rapid testing methodologies have been approved for testing of symptomatic individuals but have not been validated for asymptomatic screening. We evaluated performance of the Abbott PanbioTM COVID-19 rapid antigen assay in the asymptomatic setting. We conducted a prospective study in an urban assessment center and in the context of long-term care staff screening. A total of 3014 individuals submitted paired nasopharyngeal samples, which were tested in parallel with the rapid antigen and laboratory-based, RT-PCR assays SARS-CoV-2 detection. There was 54.5% concordance in positive results between the rapid antigen assay and RT-PCR. All positive rapid antigen assay results were confirmed by RT-PCR. The negative predictive value of the rapid antigen assay minimally improved on the negative pre-test probability of SARS-CoV-2 infection. The Abbott PanbioTM COVID-19 rapid antigen test allowed for faster identification of infected individuals but cannot be used to rule-out SARS-CoV-2 infection.