scholarly journals Multi-centre post-implementation evaluation of SARS-CoV-2 antigen-based point of care tests used for asymptomatic screening of continuing care healthcare workers

2021 ◽  
Author(s):  
Jamil N Kanji ◽  
Dustin Proctor ◽  
William Stokes ◽  
Byron M Berenger ◽  
James Silvius ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
Clinical Performance ◽  
Point Of Care ◽  
Reference Method ◽  
Continuing Care ◽  
Implementation Evaluation ◽  
False Positive Detection ◽  
Polymerase Chain ◽  
Point Of Care Tests ◽  
Careful Assessment

Frequent screening of SARS-CoV-2 among asymptomatic populations using antigen-based point of care tests (APOCT) is occurring globally with limited clinical performance data. The positive predictive value (PPV) of two APOCT used in the asymptomatic screening of SARS-CoV-2 among healthcare workers (HCW) at continuing care (CC) sites across Alberta, Canada was evaluated. Between February 22 and May 2, 2021, CC sites implemented SARS-CoV-2 voluntary screening of their asymptomatic HCW. Onsite testing with Abbott Panbio or BD Veritor occurred on a weekly or twice weekly basis. Positive APOCT were confirmed with a real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) reference method. A total of 71,847 APOCT (17,689 Veritor and 54,158 Panbio) were performed among 369 CC sites. Eighty-seven (0.12%) APOCT were positive, of which 39 (0.05%) confirmed as true positives using rRT-PCR. Use of the Veritor and Panbio resulted in a 76.6% and 30.0% false positive detection, respectively (p<0.001). This corresponded to a 23.4% and 70.0% PPV for the Veritor and Panbio, respectively. Frequent screening of SARS-CoV-2 among asymptomatic HCW in CC, using APOCT, resulted in a very low detection rate and a high detection of false positives. Careful assessment between the risks vs benefits of APOCT programs in this population needs to be thoroughly considered before implementation.

scholarly journals Multicentre post-implementation assessment of the positive-predictive value of SARS-CoV-2 antigen-based point-of-care tests used for asymptomatic screening of continuing care staff

2021 ◽  
Author(s):  
Jamil N Kanji ◽  
Dustin T Proctor ◽  
William Stokes ◽  
Byron M Berenger ◽  
James Silvius ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Predictive Value ◽  
Clinical Performance ◽  
Point Of Care ◽  
Reference Method ◽  
Care Staff ◽  
Continuing Care ◽  
False Positive Detection ◽  
Polymerase Chain ◽  
Point Of Care Tests

Frequent screening of SARS-CoV-2 among asymptomatic populations using antigen-based point of care tests (APOCT) is occurring globally with limited clinical performance data. The positive predictive value (PPV) of two APOCT used in the asymptomatic screening of SARS-CoV-2 among healthcare workers (HCW) at continuing care (CC) sites across Alberta, Canada was evaluated. Between February 22 and May 2, 2021, CC sites implemented SARS-CoV-2 voluntary screening of their asymptomatic HCW. Onsite testing with Abbott Panbio or BD Veritor occurred on a weekly or twice weekly basis. Positive APOCT were confirmed with a real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) reference method. A total of 71,847 APOCT (17,689 Veritor and 54,158 Panbio) were performed among 369 CC sites. Eighty-seven (0.12%) APOCT were positive, of which 39 (0.05%) confirmed as true positives using rRT-PCR. Use of the Veritor and Panbio resulted in a 76.6% and 30.0% false positive detection, respectively (p<0.001). This corresponded to a 23.4% and 70.0% PPV for the Veritor and Panbio, respectively. Frequent screening of SARS-CoV-2 among asymptomatic HCW in CC, using APOCT, resulted in a very low detection rate and a high detection of false positives. Careful assessment between the risks vs benefits of APOCT programs and prevalence of infection in this population needs to be thoroughly considered before implementation.

scholarly journals Comparison of Four Commercially Available Point-of-Care Tests to Detect Antibodies against Canine Parvovirus in Dogs

Viruses ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 18
Author(s):  
Michèle Bergmann ◽  
Mike Holzheu ◽  
Yury Zablotski ◽  
Stephanie Speck ◽  
Uwe Truyen ◽  
...  
Keyword(s):  
Test Performance ◽  
Point Of Care ◽  
Reference Method ◽  
Canine Parvovirus ◽  
P Value ◽  
Important Indicator ◽  
Specificity And Sensitivity ◽  
Specific Pathogen ◽  
The One ◽  
Point Of Care Tests

Measuring antibodies to evaluate dogs´ immunity against canine parvovirus (CPV) is useful to avoid unnecessary re-vaccinations. The study aimed to evaluate the quality and practicability of four point-of-care (POC) tests for detection of anti-CPV antibodies. The sera of 198 client-owned and 43 specific pathogen-free (SPF) dogs were included; virus neutralization was the reference method. Specificity, sensitivity, positive and negative predictive value (PPV and NPV), and overall accuracy (OA) were calculated. Specificity was considered to be the most important indicator for POC test performance. Differences between specificity and sensitivity of POC tests in the sera of all dogs were determined by McNemar, agreement by Cohen´s kappa. Prevalence of anti-CPV antibodies in all dogs was 80% (192/241); in the subgroup of client-owned dogs, it was 97% (192/198); and in the subgroup of SPF dogs, it was 0% (0/43). FASTest® and CanTiCheck® were easiest to perform. Specificity was highest in the CanTiCheck® (overall dogs, 98%; client-owned dogs, 83%; SPF dogs, 100%) and the TiterCHEK® (overall dogs, 96%; client-owned dogs, 67%; SPF dogs, 100%); no significant differences in specificity were observed between the ImmunoComb®, the TiterCHEK®, and the CanTiCheck®. Sensitivity was highest in the FASTest® (overall dogs, 95%; client-owned dogs, 95%) and the CanTiCheck® (overall dogs, 80%; client-owned dogs, 80%); sensitivity of the FASTest® was significantly higher compared to the one of the other three tests (McNemars p-value in each comparison: <0.001). CanTiCheck® would be the POC test of choice when considering specificity and practicability. However, differences in the number of false positive results between CanTiCheck®, TiterCHEK®, and ImmunoComb® were minimal.

scholarly journals Formulating Design Recommendations for the Acceptance of the Use and Results of Point-of-Care Testing in Low- and Middle-Income Countries: A Literature Review

2019 ◽  
Vol 1 (1) ◽  
pp. 2795-2804
Author(s):  
Yvonne Jolanda Melanie Licher ◽  
Jan Simon Visser ◽  
G-Young Van ◽  
Jan Carel Diehl
Keyword(s):  
Healthcare Workers ◽  
Point Of Care ◽  
Waiting Times ◽  
Point Of Care Testing ◽  
Middle Income ◽  
Future Design ◽  
Middle Income Countries ◽  
Barriers And Opportunities ◽  
Point Of Care Tests ◽  
Low And Middle Income

AbstractIn low- and middle-income countries (LMIC), diagnostics are not always available in remote areas. Hospitals and healthcare centres are often too far from the community, and waiting times are up to a few hours even for relatively simple procedures. Moreover, travelling to the healthcare centre and taking the diagnostic test is frequently unaffordable. Point of Care Tests (POCTs) can improve the availability, accessibility and affordability of the diagnostics by providing the test at the time and place of patient care. Although many POCTs have been developed already, there remain challenges to enable the healthcare workers (HCW) and the patients to use the device in practice. In this paper, we aim to provide a systemic overview of the barriers and opportunities for the adoption of use and acceptance of the results of POCTs based on the literature. The barriers and opportunities were clustered into six themes and used to draw out recommendations for the future design.

scholarly journals Diagnostic Accuracy and User-Friendliness of 5 Point-of-Care D-Dimer Tests for the Exclusion of Deep Vein Thrombosis

2010 ◽  
Vol 56 (11) ◽  
pp. 1758-1766 ◽  
Author(s):  
Geert-Jan Geersing ◽  
Diane B Toll ◽  
Kristel JM Janssen ◽  
Ruud Oudega ◽  
Marloes JC Blikman ◽  
...  
Keyword(s):  
Primary Care ◽  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Reference Method ◽  
Roc Curves ◽  
Color Contrast ◽  
User Friendliness ◽  
Predictive Values ◽  
Point Of Care Tests ◽  
D Dimer

BACKGROUND Point-of-care D-dimer tests have recently been introduced to enable rapid exclusion of deep venous thrombosis (DVT) without the need to refer a patient for conventional laboratory-based D-dimer testing. Before implementation in practice, however, the diagnostic accuracy of each test should be validated. METHODS We analyzed data of 577 prospectively identified consecutive primary care patients suspected to have DVT, who underwent 5 point-of-care D-dimer tests—4 quantitative (Vidas®, Pathfast™, Cardiac®, and Triage®) and 1 qualitative (Clearview Simplify®)—and ultrasonography as the reference method. We evaluated the tests for the accuracy of their measurements and submitted a questionnaire to 20 users to assess the user-friendliness of each test. RESULTS All D-dimer tests showed negative predictive values higher than 98%. Sensitivity was high for all point-of-care tests, with a range of 0.91 (Clearview Simplify) to 0.99 (Vidas). Specificity varied between 0.39 (Pathfast) and 0.64 (Clearview Simplify). The quantitative point-of-care tests showed similar and high discriminative power for DVT, according to calculated areas under the ROC curves (range 0.88–0.89). The quantitative Vidas and Pathfast devices showed limited user-friendliness for primary care, owing to a laborious calibration process and long analyzer warm-up time compared to the Cardiac and Triage. For the qualitative Clearview Simplify assay, no analyzer or calibration was needed, but interpretation of a test result was sometimes difficult because of poor color contrast. CONCLUSIONS Point-of-care D-dimer assays show good and similar diagnostic accuracy. The quantitative Cardiac and Triage and the qualitative Clearview Simplify D-dimer seem most user-friendly for excluding DVT in the doctor's office.

scholarly journals Clinical Performance of (1,3) Beta-D Glucan for the Diagnosis of Pneumocystis Pneumonia (PCP) in Cancer Patients Tested With PCP Polymerase Chain Reaction

2018 ◽  
Vol 69 (8) ◽  
pp. 1303-1309 ◽  
Author(s):  
Sejal Morjaria ◽  
John Frame ◽  
Alexandra Franco-Garcia ◽  
Alexander Geyer ◽  
Mini Kamboj ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Cancer Patients ◽  
Predictive Value ◽  
Clinical Performance ◽  
Reference Method ◽  
Pneumocystis Pneumonia ◽  
Clinical Syndrome ◽  
Chain Reaction ◽  
Polymerase Chain ◽  
High Risk Cancer

Abstract Background Serum (1,3)-beta-D glucan (BDG) is increasingly used to guide the management of suspected Pneumocystis pneumonia (PCP). BDG lacks specificity for PCP, and its clinical performance in high-risk cancer patients has not been fully assessed. Polymerase chain reaction (PCR) for PCP detection is highly sensitive, but cannot differentiate between colonization and infection. We evaluated the diagnostic performance of serum BDG in conjunction with PCP PCR on respiratory samples in patients with cancer and unexplained lung infiltrates. Methods We performed a retrospective analysis of adult patients evaluated for PCP at our institution from 2012 to 2015, using serum BDG and PCP PCR. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the serum BDG at different thresholds were evaluated using PCP PCR alone or in conjunction with clinical presentation in PCP PCR–positive patients. Results With PCP PCR alone as the reference method, BDG (≥80 pg/mL) had a sensitivity of 69.8%, specificity of 81.2%, PPV of 34.6%, and NPV of 95.2% for PCP. At ≥200 pg/mL in patients with a positive PCR and a compatible PCP clinical syndrome, BDG had a sensitivity of 70%, specificity of 100%, PPV of 100%, and NPV of 52.0% for PCP. Conclusions Patients negative by both BDG and PCR were unlikely to have PCP. In patients with a compatible clinical syndrome for PCP, higher BDG values (>200 pg/mL) were consistently associated with clinically-significant PCP infections among PCP PCR–positive oncology patients.

scholarly journals Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen

2020 ◽  
Vol 9 (1) ◽  
pp. 58
Author(s):  
Annabelle Strömer ◽  
Ruben Rose ◽  
Miriam Schäfer ◽  
Frieda Schön ◽  
Anna Vollersen ◽  
...  
Keyword(s):  
Rapid Detection ◽  
Point Of Care ◽  
Rapid Test ◽  
Vero Cells ◽  
Upper Respiratory Tract ◽  
Rt Pcr ◽  
Nucleoprotein Gene ◽  
Point Of Care Test ◽  
Polymerase Chain ◽  
Point Of Care Tests

The rapid detection of infections caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is necessary in the ongoing pandemic. Antigen-specific point-of-care tests (POCT) may be useful for this purpose. Here, such a POCT (SARS-CoV-2 NADAL® COVID-19 Ag) was compared to a laboratory-developed triplex real-time polymerase chain reaction (RT-PCR) designed for the detection of viral nucleoprotein gene and two control targets. This RT-PCR served as a reference to investigate POCT sensitivity by re-testing upper respiratory tract (URT) samples (n = 124) exhibiting different SARS-CoV-2 loads in terms of RT-PCR threshold cycle (Ct) values. The optical intensities of the antigen bands were compared to the Ct values of the RT-PCR. The infectivity of various virus loads was estimated by inoculating Vero cells with URT samples (n = 64, Ct 17-34). POCT sensitivity varied from 100% (Ct < 25) to 73.1% (Ct ≤ 30); higher SARS-CoV-2 loads correlated with higher band intensities. All samples with a Ct > 30 were negative; among SARS-CoV-2 free samples (n = 10) no false-positives were detected. A head-to-head comparison with another POCT (Abbott, Panbio™ COVID-19 Ag Rapid Test) yielded similar results. Isolation of SARS-CoV-2 in cell-culture was successful up to a Ct value of 29. The POCT reliably detects high SARS-CoV-2 loads and rapidly identifies infectious individuals.

scholarly journals Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020

2021 ◽  
Vol 26 (45) ◽  
Author(s):  
Ivo Van Walle ◽  
Katrin Leitmeyer ◽  
Eeva K Broberg ◽  
Keyword(s):  
Nucleic Acid ◽  
Confidence Interval ◽  
Clinical Performance ◽  
Point Of Care ◽  
Test Results ◽  
Interval Width ◽  
Point Of Care Tests ◽  
Antibody Tests ◽  
Confidence Interval Width ◽  
Nucleic Acid Tests

Background Reliable testing for SARS-CoV-2 is key for the management of the COVID-19 pandemic. Aim We estimate diagnostic accuracy for nucleic acid and antibody tests 5 months into the COVID-19 pandemic, and compare with manufacturer-reported accuracy. Methods We reviewed the clinical performance of SARS-CoV-2 nucleic acid and antibody tests based on 93,757 test results from 151 published studies and 20,205 new test results from 12 countries in the European Union and European Economic Area (EU/EEA). Results Pooling the results and considering only results with 95% confidence interval width ≤ 5%, we found four nucleic acid tests, including one point-of-care test and three antibody tests, with a clinical sensitivity ≥ 95% for at least one target population (hospitalised, mild or asymptomatic, or unknown). Nine nucleic acid tests and 25 antibody tests, 12 of them point-of-care tests, had a clinical specificity of ≥ 98%. Three antibody tests achieved both thresholds. Evidence for nucleic acid point-of-care tests remains scarce at present, and sensitivity varied substantially. Study heterogeneity was low for eight of 14 sensitivity and 68 of 84 specificity results with confidence interval width ≤ 5%, and lower for nucleic acid tests than antibody tests. Manufacturer-reported clinical performance was significantly higher than independently assessed in 11 of 32 and four of 34 cases, respectively, for sensitivity and specificity, indicating a need for improvement in this area. Conclusion Continuous monitoring of clinical performance within more clearly defined target populations is needed.

scholarly journals Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid, antigen and antibody tests up to 22 August 2020

2020 ◽  
Author(s):  
Ivo Van Walle ◽  
Katrin Leitmeyer ◽  
Eeva K Broberg ◽  
Keyword(s):  
Nucleic Acid ◽  
Confidence Interval ◽  
Clinical Performance ◽  
Point Of Care ◽  
Test Results ◽  
Interval Width ◽  
Point Of Care Tests ◽  
Antibody Tests ◽  
Confidence Interval Width ◽  
Nucleic Acid Tests

We reviewed the clinical performance of SARS-CoV-2 nucleic acid, viral antigen and antibody tests based on 94739 test results from 157 published studies and 20205 new test results from 12 EU/EEA Member States. Pooling the results and considering only results with 95% confidence interval width ≤5%, we found 4 nucleic acid tests, among which 1 point of care test, and 3 antibody tests with a clinical sensitivity ≤95% for at least one target population (hospitalised, mild or asymptomatic, or unknown). Analogously, 9 nucleic acid tests and 25 antibody tests, among which 12 point of care tests, had a clinical specificity of ≤98%. Three antibody tests achieved both thresholds. Evidence for nucleic acid and antigen point of care tests remains scarce at present, and sensitivity varied substantially. Study heterogeneity was low for 8/14 (57.1%) sensitivity and 68/84 (81.0%) specificity results with confidence interval width ≤5%, and lower for nucleic acid tests than antibody tests. Manufacturer reported clinical performance was significantly higher than independently assessed in 11/32 (34.4%) and 4/34 (11.8%) cases for sensitivity and specificity respectively, indicating a need for improvement in this area. Continuous monitoring of clinical performance within more clearly defined target populations is needed.

scholarly journals Real-World Clinical Performance of the Abbott Panbio with Nasopharyngeal, Throat and Saliva Swabs Among Symptomatic Individuals with COVID-19

2021 ◽  
Author(s):  
William Stokes ◽  
Byron M. Berenger ◽  
Danielle Portnoy ◽  
Brittney Scott ◽  
Jonas Szelewicki ◽  
...  
Keyword(s):  
Symptom Onset ◽  
Clinical Performance ◽  
Point Of Care ◽  
Community Setting ◽  
Rt Pcr ◽  
Chain Reaction ◽  
False Negatives ◽  
Polymerase Chain ◽  
Antigen Tests ◽  
Health Canada

Abstract BACKGROUND Point of Care SARS-CoV-2 antigen tests, such as the Abbott Panbio, have great potential to help combat the COVID-19 pandemic. The Panbio is Health Canada approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7 days of COVID-19 symptom onset(s). METHODS Symptomatic adults recently diagnosed with COVID-19 in the community were recruited into the study. Paired nasopharyngeal (NP), throat, and saliva swabs were collected, with one paired swab tested immediately with the Panbio, and the other transported in universal transport media and tested using reverse-transcriptase polymerase chain reaction (RT-PCR). We also prospectively evaluated results from assessment centres. For those individuals, an NP swab was collected for Panbio testing and paired with RT-PCR results from parallel NP or throat swabs. RESULTS 145 individuals were included in the study. Collection of throat and saliva was stopped early due to poorer performance (throat sensitivity 57.7%, n = 61, and saliva sensitivity 2.6%, n = 41). NP swab sensitivity was 87.7% [n = 145, 95% confidence interval (CI) 81.0% − 92.7%]. There were 1,641 symptomatic individuals tested by Panbio in assessment centres, with 268/1641 (16.3%) positive for SARS-CoV-2. There were 37 false negatives and 2 false positives, corresponding to a sensitivity and specificity of 86.1% [95% CI 81.3% − 90.0%] and 99.9% [95% CI 99.5% − 100.0%], respectively. CONCLUSIONS The Panbio test reliably detects most cases of SARS-CoV-2 from adults in the community setting presenting within 7 days of symptom onset using nasopharyngeal swabs. Throat and saliva swabs are not reliable specimens for the Panbio.

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