scholarly journals Clinical Evaluation and Utilization of Multiple Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2

2020 ◽  
Vol 154 (2) ◽  
pp. 201-207 ◽  
Author(s):  
Kendall Cradic ◽  
Marie Lockhart ◽  
Patrick Ozbolt ◽  
Lisa Fatica ◽  
Lorie Landon ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Nasopharyngeal Swab ◽  
Separate Analysis ◽  
Assay Sensitivity ◽  
Limits Of Detection ◽  
Diagnostic Assays ◽  
Percent Agreement ◽  
In Vitro Diagnostic ◽  
Roche Cobas

Abstract Objectives To evaluate the clinical performance of 3 molecular assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods We used 184 nasopharyngeal swab specimens to compare Abbott ID NOW COVID-19 (Abbott ID NOW), DiaSorin Molecular Simplexa COVID-19 Direct (DiaSorin Simplexa), and Roche cobas 6800 SARS-CoV-2 (Roche cobas) assays. In a separate analysis, 3 specimens (nasopharyngeal, oropharyngeal, and nasal) were collected from 182 unique patients presenting to the emergency department with suspicion of coronavirus disease 2019 and were tested utilizing Abbott ID NOW. To further characterize each assay, relative limits of detection were evaluated utilizing positive nasopharyngeal patient samples. Results The positive percent agreement was 91% (95% confidence interval [CI], 0.76-0.97) for Abbott ID NOW and 100% (95% CI, 0.90-1.00) for DiaSorin Simplexa and Roche cobas. The negative percent agreement was 100% (95% CI, 0.98-1.00) for all 3 assays. All swab types tested with the Abbott assay produced concordant results. Polymerase chain reaction assays had approximately 10 to 100 times lower limits of detection than Abbott ID NOW. Conclusions Based on these evaluations, a multiplatform testing approach is proposed, depending on patient population and assay sensitivity, to address testing needs during a public health emergency.

scholarly journals Performance evaluation of the BD SARS-CoV-2 reagents for the BD MAX™ system

2021 ◽  
Author(s):  
Karen Yanson ◽  
William Laviers ◽  
Lori Neely ◽  
Elizabeth Lockamy ◽  
Luis Carlos Castillo-Hernandez ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
Clinical Study ◽  
Nucleic Acid ◽  
Clinical Performance ◽  
Nucleic Acid Amplification ◽  
Standard Approach ◽  
Limits Of Detection ◽  
Percent Agreement ◽  
Post Market ◽  
Roche Cobas

Background Nucleic acid amplification testing (NAAT) for SARS-CoV-2 is the standard approach for confirming COVID-19 cases. This study compared results between two Emergency Use Authorization (EUA) NAATs, with two additional EUA NAATs utilized for discrepant testing. Methods The limits of detection (LOD) for the BD SARS-CoV-2 Reagents for BD MAX™ System (“MAX SARS-CoV-2 assay”), the Biomerieux BioFire® Respiratory Panel 2.1 (“BioFire SARS-CoV-2 assay”), the Roche cobas SARS-CoV-2 assay (“cobas SARS-CoV-2 assay”), and the Hologic Aptima® SARS-CoV-2 assay Panther® (“Aptima SARS-CoV-2 assay”) NAAT systems were determined using a total of 84 contrived nasopharyngeal specimens with seven target levels for each comparator. The positive and negative percent agreement (PPA and NPA, respectively) of the MAX SARS-CoV-2 assay, compared to the Aptima SARS-CoV-2 assay, was evaluated in a post-market clinical study utilizing 708 nasopharyngeal specimens collected from suspected COVID-19 cases. Discordant testing was achieved using cobas and BioFire SARS-CoV-2 NAATs. Results In this study, the measured LOD for the MAX SARS-CoV-2 assay (251 copies/mL; [95%CI: 186, 427]) was comparable to the cobas SARS-CoV-2 assay (298 copies/mL; [95%CI: 225, 509]) and the BioFire SARS-CoV-2 assay (302 copies/mL; [95%CI: 219, 565]); the Aptima SARS-CoV-2 assay had a LOD of 612 copies/mL; [95%CI: 474, 918]. The MAX SARS-CoV-2 assay had a PPA of 100% (95%CI: [97.3%-100.0%]) and a NPA of 96.7% (95%CI: [94.9%-97.9%]) when compared to the Aptima SARS-CoV-2 assay. Conclusions The clinical performance of the MAX SARS-CoV-2 assay agreed with another sensitive EUA assay.

scholarly journals Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens

2020 ◽  
Author(s):  
Wei Zhen ◽  
Ryhana Manji ◽  
Elizabeth Smith ◽  
Gregory J. Berry
Keyword(s):  
Respiratory Infections ◽  
Clinical Performance ◽  
Control Measures ◽  
Molecular Diagnostic ◽  
Analytical Sensitivity ◽  
The Novel ◽  
Diagnostic Assays ◽  
Infection Control Measures ◽  
In Vitro Diagnostic

AbstractThe novel human coronavirus SARS-CoV-2 was first discovered in the city of Wuhan, Hubei province, China, causing an outbreak of pneumonia in January 2020. As of April 10, 2020, the virus has rapidly disseminated to over 200 countries and territories, causing more than 1.6 million confirmed cases of COVID-19 and 97,000 deaths worldwide. The clinical presentation of COVID-19 is fairly non-specific, and symptoms overlap with other seasonal respiratory infections concurrently circulating in the population. Further, it is estimated that up to 80% of infected individuals experience mild symptoms or are asymptomatic, confounding efforts to reliably diagnose COVID-19 empirically. To support infection control measures, there is an urgent need for rapid and accurate molecular diagnostics to identify COVID-19 positive patients. In the present study, we have evaluated the analytical sensitivity and clinical performance of four SARS-CoV-2 molecular diagnostic assays granted Emergency Use Authorization by the FDA using nasopharyngeal swabs from symptomatic patients. This information is crucial for both laboratories and clinical teams, as decisions on which testing platform to implement are made.

PERFORMANCE OF COMMERCIALLY AVAILABLE HIV IN VITRO DIAGNOSTIC ASSAYS: SYSTEMATIC REVIEW AND META-ANALYSIS

2021 ◽  
pp. 105047
Author(s):  
Mihir Bhatta ◽  
Santanu Banerjee ◽  
Srijita Nandi ◽  
Shanta Dutta ◽  
Dr. Malay Kumar Saha
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Diagnostic Assays ◽  
In Vitro Diagnostic

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

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.

The dynamicity of light-up aptamers in one-pot in vitro diagnostic assays

The Analyst ◽  
2022 ◽  
Author(s):  
Marimuthu Citartan
Keyword(s):  
Diagnostic Assay ◽  
One Pot ◽  
Direct Modulation ◽  
Diagnostic Assays ◽  
In Vitro Diagnostic ◽  
Targeted Detection

The direct modulation of a light-up aptamer that engenders an analyte-specific aptamer-light-up aptamer chimera is readily applicable in any diagnostic assay for a targeted detection.

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