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

BACKGROUND Point of Care Testing (POCT) SARS-CoV-2 antigen tests, such as the Abbott Panbio, have great potential to help combat the COVID-19 pandemic. The Panbio is United States Food and Drug Administration (FDA) 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). Positive percent agreement (PPA) was calculated. Subsequently, individuals within 7 days of symptom onset who presented to community assessment centres for SARS-CoV-2 testing had Panbio testing completed 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 poor performance (throat PPA 57.7%, n=61, and saliva PPA 2.6%, n=41). NP swab PPA was 87.7% [n=145, 95% confidence interval 81.0% - 92.7%]. There were 1,641 symptomatic individuals tested by Panbio in community assessment centres, with 268/1641 (16.3%) positive for SARS-CoV-2. There were 37 false negatives, corresponding to a PPA of 86.2% [81.5% - 90.1%]. CONCLUSIONS The Panbio test reliably detects most cases of SARS-CoV-2 from adults in the POCT community setting presenting within 7 days of symptom onset using nasopharyngeal swabs. Throat and saliva swabs are not reliable specimens for the Panbio.

Download Full-text

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

10.21203/rs.3.rs-188293/v1 ◽

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.

Download Full-text

A novel RT-LAMP workflow for rapid salivary diagnostics of COVID-19 and effects of age, gender and time from symptom onset

10.1101/2021.06.07.21258288 ◽

2021 ◽

Author(s):

Gerson Shigeru Kobayashi ◽

Luciano Abreu Brito ◽

Danielle De Paula Moreira ◽

Angela May Suzuki ◽

Gabriella Shih Ping Hsia ◽

...

Keyword(s):

Viral Load ◽

Symptom Onset ◽

Clinical Performance ◽

Point Of Care ◽

Rapid Diagnostics ◽

Rt Pcr ◽

Point Of Care Testing ◽

Viral Loads ◽

Peak Viral Load ◽

Salivary Diagnostics

Objectives: Rapid diagnostics is pivotal to curb SARS-CoV-2 transmission, and saliva has emerged as a practical alternative to naso/oropharyngeal (NOP) specimens. We aimed to develop a direct RT-LAMP workflow for viral detection in saliva, and to provide more information regarding its potential in COVID-19 diagnostics. Methods: Clinical and contrived specimens were used to screen/optimize formulations and sample processing protocols. Salivary viral load was determined in symptomatic patients to evaluate clinical performance (n = 90) and to characterize saliva based on age, gender and time from onset of symptoms (n = 49). Results: The devised workflow achieved 93.2% sensitivity, 97% specificity, and 0.895 Kappa for salivas containing >102 copies/μL. Further analyses in saliva showed peak viral load in the first days of symptoms and lower viral loads in females, particularly among young individuals (<38 years). NOP RT-PCR data did not yield relevant associations. Conclusions: This novel saliva RT-LAMP workflow can be applied to point-of-care testing. This work reinforces that saliva better correlates with transmission dynamics than NOP specimens, and reveals gender differences that may reflect higher transmission by males. To maximize detection, testing should be done immediately after symptom onset, especially in females.

Download Full-text

Acceptable Performance of the Abbott ID NOW Among Symptomatic Individuals with Confirmed COVID-19

10.1101/2020.12.24.20248786 ◽

2020 ◽

Author(s):

William Stokes ◽

Byron M. Berenger ◽

Takshveer Singh ◽

Ifueko Adeghe ◽

Angela Schneider ◽

...

Keyword(s):

Throat Swab ◽

Small Sample Size ◽

Point Of Care ◽

The United States ◽

Small Sample ◽

Rt Pcr ◽

Pcr Assay ◽

Specimen Collection ◽

United States Food ◽

States Food

INTRODUCTIONPoint of care diagnostic tests for SARS-CoV-2, such as the ID NOW, have great potential to help combat the COVID-19 pandemic. The ID NOW is approved by the United States Food and Drug Administration (FDA) for the detection of SARS-CoV-2 in symptomatic individuals within the first 7 days of symptom onset for COVID-19 if tested within 1 hour of specimen collection. However, clinical data on the performance of the ID NOW is limited, with many studies deviating from the manufacturer’s instructions and/or having small sample size.METHODSAdults with COVID-19 in the community or hospital were recruited into the study. Paired throat swabs were collected, with one throat swab transported immediately in an empty sterile tube to the laboratory for ID NOW testing, and the other transported in universal transport media and tested by an in-house SARS-CoV-2 RT-PCR assay targeting the E-gene. Positive percent agreement (PPA) was calculated.RESULTS133 individuals were included in the study. 129 samples were positive on either the ID NOW and/or RT-PCR. Assuming any positive result on either assay represents a true positive, PPA of the ID NOW compared to RT-PCR with 95% confidence intervals was 89.1% [82.0% - 94.1%] and 91.6% [85.1% - 95.9%], respectively. When analyzing individuals with symptoms ≤ 7 days and who had the ID NOW performed within an hour, ID NOW PPA increased to 98.2%.DISCUSSIONIn this study, SARS-CoV-2 results from the ID NOW were reliable, especially when testing was adhered to manufacturer’s recommendations.

Download Full-text

In Vitro Diagnostics for COVID-19: State-of-the-Art, Future Directions and Role in Pandemic Response

10.5772/intechopen.97775 ◽

2021 ◽

Author(s):

Sandeep Kumar Vashist ◽

Subramanian Murugan ◽

Guiffo Djoko

Keyword(s):

Point Of Care ◽

Immunoglobulin A ◽

The United States ◽

Immunoglobulin M ◽

In Vitro Diagnostics ◽

Rt Pcr ◽

United States Food ◽

States Food ◽

Almost All

There have been tremendous advances in in vitro diagnostics (IVD) for coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although the confirmatory clinical diagnosis is made by real-time reverse transcriptase polymerase chain reaction (RT-PCR), lateral flow immunoassay (LFIA) based viral antigen (Ag) detection is used for mass population screening at point-of-care (POC) settings. The rapid RT-PCR tests (such as from Cepheid and Bosch) have an assay duration of less than 40 min, while most rapid Ag tests (such as Abbott’s BinaxNOW™ COVID-19 Ag card) have an assay duration of about 15 min. Of interest is the POC molecular test (ID NOW™) from Abbott that takes less than13 min. Similarly, many immunoassays (IAs), i.e., automated chemiluminescent IA (CLIA), manual ELISA, and LFIA, have been developed to detect immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) produced in subjects after SARS-CoV-2 infection. Many IVD tests have been approved by the United States Food and Drug Administration (FDA) under emergency use authorization (EUA), and almost all IVD tests are Conformité Européenne (CE) certified.

Download Full-text

Diagnosis of SARS-Cov-2 Infection by RT-PCR Using Specimens Other Than Naso- and Oropharyngeal Swabs: A Systematic Review and Meta-Analysis

Diagnostics ◽

10.3390/diagnostics11020363 ◽

2021 ◽

Vol 11 (2) ◽

pp. 363

Author(s):

Vânia M. Moreira ◽

Paulo Mascarenhas ◽

Vanessa Machado ◽

João Botelho ◽

José João Mendes ◽

...

Keyword(s):

Systematic Review ◽

Clinical Performance ◽

Point Of Care ◽

Meta Analysis ◽

High Sensitivity ◽

Nasopharyngeal Swab ◽

Sample Collection ◽

Rt Pcr ◽

Oropharyngeal Swab ◽

Nucleic Acid Assays

The rapid and accurate testing of SARS-CoV-2 infection is still crucial to mitigate, and eventually halt, the spread of this disease. Currently, nasopharyngeal swab (NPS) and oropharyngeal swab (OPS) are the recommended standard sampling techniques, yet, these have some limitations such as the complexity of collection. Hence, several other types of specimens that are easier to obtain are being tested as alternatives to nasal/throat swabs in nucleic acid assays for SARS-CoV-2 detection. This study aims to critically appraise and compare the clinical performance of RT-PCR tests using oral saliva, deep-throat saliva/posterior oropharyngeal saliva (DTS/POS), sputum, urine, feces, and tears/conjunctival swab (CS) against standard specimens (NPS, OPS, or a combination of both). In this systematic review and meta-analysis, five databases (PubMed, Scopus, Web of Science, ClinicalTrial.gov and NIPH Clinical Trial) were searched up to the 30th of December, 2020. Case-control and cohort studies on the detection of SARS-CoV-2 were included. The methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS 2). We identified 1560 entries, 33 of which (1.1%) met all required criteria and were included for the quantitative data analysis. Saliva presented the higher accuracy, 92.1% (95% CI: 70.0–98.3), with an estimated sensitivity of 83.9% (95% CI: 77.4–88.8) and specificity of 96.4% (95% CI: 89.5–98.8). DTS/POS samples had an overall accuracy of 79.7% (95% CI: 43.3–95.3), with an estimated sensitivity of 90.1% (95% CI: 83.3–96.9) and specificity of 63.1% (95% CI: 36.8–89.3). The remaining index specimens could not be adequately assessed given the lack of studies available. Our meta-analysis shows that saliva samples from the oral region provide a high sensitivity and specificity; therefore, these appear to be the best candidates for alternative specimens to NPS/OPS in SARS-CoV-2 detection, with suitable protocols for swab-free sample collection to be determined and validated in the future. The distinction between oral and extra-oral salivary samples will be crucial, since DTS/POS samples may induce a higher rate of false positives. Urine, feces, tears/CS and sputum seem unreliable for diagnosis. Saliva testing may increase testing capacity, ultimately promoting the implementation of truly deployable COVID-19 tests, which could either work at the point-of-care (e.g. hospitals, clinics) or at outbreak control spots (e.g., schools, airports, and nursing homes).

Download Full-text

Point-Of-Care Clinical Evaluation of the Clungene® SARS-CoV-2 Virus IgG/IgM 15-minute rapid test cassette with the Cobas® Roche RT-PCR platform in patients with or without Covid-19

LymphoSign Journal ◽

10.14785/lymphosign-2021-0017 ◽

2021 ◽

Author(s):

Fadi Haddad ◽

Christopher C Lamb ◽

Ravina Kullar ◽

George Sakoulas

Keyword(s):

Symptom Onset ◽

Serological Test ◽

Point Of Care ◽

Diagnostic Testing ◽

Rapid Test ◽

Lateral Flow ◽

Added Value ◽

Lateral Flow Immunoassay ◽

Rt Pcr ◽

Past Infection

Background: Covid-19 remains a pandemic with multiple challenges to confirm patient infectivity: lack of sufficient tests, accurate results, validated quality, and timeliness of results. We hypothesize that a rapid 15-minute Point-Of-Care serological test to evaluate past infection complements diagnostic testing for Covid-19 and significantly enhances testing availability. Method: A three arm observational study at Sharp Healthcare, San Diego, California was conducted using the Clungene® lateral flow immunoassay (LFI) and compared with the Cobas® Roche RT PCR results. Arm 1: Thirty-five (35) subjects with confirmed Covid-19 using RT-PCR were tested twice: prior to 14 days following symptom onset and once between 12 and 70 days. Arm 2: Thirty (30) subjects with confirmed Covid-19 using RT-PCR were tested 12-70 days post symptom onset. Arm 3: Thirty (30) subjects with a negative RT-PCR for Covid-19 were tested 1-10 days following the RT-PCR test date. Results: Specificity of confirmed negative Covid-19 by RT-PCR was 100% (95% CI, 88.4%-100.0%); meaning there was 100% negative positive agreement between the RT-PCR and the Clungene® serological test results. Covid-19 subjects tested prior to day 7 symptom onset were antibody negative. In subjects 7-12 days following symptom onset with a confirmed positive Covid-19 by RT-PCR, the combined sensitivity of IgM and IgG was 58.6% (95% CI, 38.9%-76.5%). In subjects 13-70 days following symptom onset with a confirmed positive Covid-19 by RT-PCR the combined sensitivity of IgM and IgG was 90.5% (95% CI, 80.4%-96.4%). Conclusion: The Clungene® lateral flow immunoassay (LFI) is a useful tool to confirm individuals with an adaptive immune response to SARS-CoV-2 indicating past infection. Providing Point-Of-Care results within 15 minutes without any laboratory instrumentation or specialized software has an added value of increasing test availability to patients who have been symptomatic for more than one week to confirm past infection. Performance characteristics are optimal after 13 days with a sensitivity and specificity of 90% and 100%, respectively.

Download Full-text

Clinical performance of the point-of-care cobas Liat for detection of SARS-CoV-2 in 20 minutes: A multicenter study

Journal of Clinical Microbiology ◽

10.1128/jcm.02811-20 ◽

2020 ◽

Author(s):

Glen Hansen ◽

Jamie Marino ◽

Zi-Xuan Wang ◽

Kathleen G. Beavis ◽

John Rodrigo ◽

...

Keyword(s):

Influenza A ◽

Clinical Performance ◽

Point Of Care ◽

Nasopharyngeal Swab ◽

Molecular Testing ◽

Rt Pcr ◽

Percent Agreement ◽

Individual Care ◽

Pcr Technology ◽

Acid Test

Background: Highly accurate testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the point of care (POC) is an unmet diagnostic need in emergency care and time-sensitive outpatient care settings. Reverse transcription-polymerase chain reaction (RT-PCR) technology is the gold-standard for SARS-CoV-2 diagnostics. Methods: We performed a multi-site United States (US) study comparing the clinical performance of the first US Food and Drug Administration (FDA) authorized POC RT-PCR test for detection of SARS-CoV-2 in 20 minutes, the cobas® Liat SARS-CoV-2 & Influenza A/B nucleic acid test, to the most widely used RT-PCR laboratory test, the cobas® 68/8800 SARS-CoV-2 test. Results: Clinical nasopharyngeal swab specimens from 444 patients with 357 evaluable specimens at five US clinical laboratories were enrolled from September 21, 2020 to October 23, 2020. The overall agreement between the Liat and 68/8800 systems for SARS-CoV-2 diagnostics was 98.6% (352/357). Using Liat, positive percent agreement for SARS-CoV-2 was 100% (162/162) and the negative percent agreement was 97.4% (190/195). Conclusion: The Liat is an RT-PCR POC test that provides highly accurate SARS-CoV-2 results in 20 minutes with equivalent performance to high-throughput laboratory molecular testing. Rapid RT-PCR testing at the POC can enable more timely infection control and individual care decisions for Coronavirus Disease 2019.

Download Full-text

Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA

The Journal of Applied Laboratory Medicine ◽

10.1093/jalm/jfaa135 ◽

2020 ◽

Vol 5 (6) ◽

pp. 1307-1312 ◽

Cited By ~ 1

Author(s):

Bryan Stevens ◽

Catherine A Hogan ◽

Malaya K Sahoo ◽

ChunHong Huang ◽

Natasha Garamani ◽

...

Keyword(s):

Test Performance ◽

Target Genes ◽

Point Of Care ◽

The United States ◽

Kappa Coefficient ◽

Nucleic Acid Amplification ◽

Limited Data ◽

Percent Agreement ◽

United States Food ◽

States Food

Abstract Background Numerous nucleic acid amplification assays utilizing different target genes of the SARS-CoV-2 genome have received emergency use authorization (EUA) by the United States Food and Drug Administration (FDA). Limited data are available comparing the test performance characteristics of these assays. Methods A diagnostic comparison study was performed to evaluate the performance of the Cepheid Xpert Xpress SARS-CoV-2 assay compared to the Hologic Panther Fusion SARS-CoV-2 assay using clinical nasopharyngeal specimens. Agreement between the two assays was assessed by overall, positive, and negative percent agreement and Cohen’s kappa coefficient. Results A total of 104 (54 positive and 50 negative) clinical nasopharyngeal samples were tested by both assays. Using the Panther Fusion as a reference standard, the Xpert demonstrated an overall agreement of 99.0% [95% confidence interval (CI): 94.8–100], positive percent agreement of 98.1% (95% CI: 90.1–100), and a negative percent agreement of 100% (95% CI: 94.2–100). The kappa coefficient was 0.98 (95% CI: 0.94–1.0). One sample positive by the Panther Fusion with a cycle threshold (Ct) of 38.6 was found to be reproducibly negative by the Xpert assay. Conclusions The Cepheid Xpert Xpress SARS-CoV-2 assay provides test performance comparable to the Hologic Panther Fusion SARS-CoV-2 assay while offering laboratories rapid, on-demand testing capacity.

Download Full-text

Performance evaluation of an automated SARS-CoV-2 Ag test for the diagnosis of COVID-19 infection on nasopharyngeal swabs

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2021-0569 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Cédric Hartard ◽

Sibel Berger ◽

Thomas Josse ◽

Evelyne Schvoerer ◽

Hélène Jeulin

Keyword(s):

Performance Evaluation ◽

Negative Predictive Value ◽

Symptom Onset ◽

Predictive Value ◽

Rt Pcr ◽

Infected People ◽

Antigen Tests

Abstract Objectives The detection of SARS-CoV-2 in infected people is a key tool to help in controlling COVID-19 pandemic. Like rapid antigenic tests, automated antigen tests, that present the advantage of a higher throughput flow, may be of interest. The LIAISON® SARS-CoV-2 Ag test was evaluated for the quantification of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal swabs by comparison to RT-PCR. Methods The study involved 378 nasopharyngeal samples (UTM® and FLOQSwab™, Copan Diagnostics), including 46 swabs positive for SARS-CoV-2 by RT-PCR. These samples came from asymptomatic (n=99, 26.2%) or symptomatic people (n=279, 73.8%), at different times from symptom onset. The samples were analyzed on LIAISON® XL. Results The overall specificity was 99.4% (CI95% [98.6–100]). The negative predictive value reached 100% in asymptomatic people. Among the 46 positive samples, the overall sensitivity was 84.8% (CI95% [74.4–95.2]), reached 91.9% (CI95% [83.1–100]) in the first fourth days after symptoms onset and was 100% for Cq values ≤25. Antigen was not detected in samples with Cq values >25. Similar results were observed on nasopharyngeal swabs coming from patients infected with the 20I/501Y.V1 variant or the 20H/501Y.V2 variant. Conclusions According to technical performances, the LIAISON® SARS-CoV-2 Ag test may be a useful tool for COVID-19 diagnosis, especially during the first four days of symptoms.

Download Full-text

Clinical Evaluation of the Novel Rapid Nucleic Acid Amplification Point-of-Care Test (Smart Gene SARS-CoV-2) in the analysis of Nasopharyngeal and Anterior Nasal samples.

10.1101/2021.08.25.21262583 ◽

2021 ◽

Author(s):

Yoshihiko Kiyasu ◽

Masato Owaku ◽

Yusaku Akashi ◽

Yuto Takeuchi ◽

Kenji Narahara ◽

...

Keyword(s):

Real Time ◽

Clinical Performance ◽

Point Of Care ◽

Nucleic Acid Amplification ◽

Molecular Testing ◽

The Novel ◽

Rt Pcr ◽

Pcr Assay ◽

Point Of Care Test ◽

Hands On

Introduction Smart Gene is a point-of-care (POC)-type automated molecular testing platform that can be performed with 1 minute of hands-on-time. Smart Gene SARS-CoV-2 is a newly developed Smart Gene molecular assay for the detection of SARS-CoV-2. The analytical and clinical performance of Smart Gene SARS-CoV-2 has not been evaluated. Methods Nasopharyngeal and anterior nasal samples were prospectively collected from subjects referred to the local PCR center from March 25 to July 5, 2021. Two swabs were simultaneously obtained for the Smart Gene SARS-CoV-2 assay and the reference real-time RT-PCR assay, and the results of Smart Gene SARS-CoV-2 were compared to the reference real-time RT-PCR assay. Results Among a total of 1150 samples, 68 of 791 nasopharyngeal samples and 51 of 359 anterior nasal samples were positive for SARS-CoV-2 in the reference real-time RT-PCR assay. In the testing of nasopharyngeal samples, Smart Gene SARS-CoV-2 showed the total, positive and negative concordance of 99.2% (95% confidence interval [CI]: 98.4–99.7%), 94.1% (95% CI: 85.6–98.4%) and 99.7% (95% CI: 99.0–100%), respectively. For anterior nasal samples, Smart Gene SARS-CoV-2 showed the total, positive and negative concordance of 98.9% (95% CI: 97.2–99.7%), 98.0% (95% CI: 89.6–100%) and 99.0% (95% CI: 97.2–99.8%), respectively. In total, 5 samples were positive in the reference real-time RT-PCR and negative in Smart Gene SARS-CoV-2, whereas 5 samples were negative in the reference real-time RT-PCR and positive in Smart Gene SARS-CoV-2. Conclusion Smart Gene SARS-CoV-2 showed sufficient analytical performance for the detection of SARS-CoV-2 in nasopharyngeal and anterior nasal samples.

Download Full-text