scholarly journals The PRONTO study: Clinical performance of ID NOW in individuals with compatible SARS-CoV-2 symptoms in walk-in centres—accelerated turnaround time for contact tracing

2021 ◽  
Vol 47 (12) ◽  
pp. 534-542
Author(s):  
Isabelle Goupil-Sormany ◽  
Jean Longtin ◽  
Jeannot Dumaresq ◽  
Marieve Jacob-Wagner ◽  
Frédéric Bouchard ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Point Of Care ◽  
Standard Of Care ◽  
Turnaround Time ◽  
Nucleic Acid Amplification ◽  
Contact Tracing ◽  
Test Results ◽  
Predictive Values ◽  
Negative Results ◽  
Paired Samples

Background: This PRONTO study investigated the clinical performance of the Abbott ID NOWTM (IDN) COVID-19 diagnostic assay used at point of care and its impact on turnaround time for divulgation of test results. Methods: Prospective study conducted from December 2020 to February 2021 in acute symptomatic participants presenting in three walk-in centres in the province of Québec. Results: Valid paired samples were obtained from 2,372 participants. A positive result on either the IDN or the standard-of-care nucleic acid amplification test (SOC-NAAT) was obtained in 423 participants (prevalence of 17.8%). Overall sensitivity of IDN and SOC-NAAT were 96.4% (95% CI: 94.2–98.0%) and 99.1% (95% CI: 97.6–99.8), respectively; negative predictive values were 99.2% (95% CI: 98.7–99.6%) and 99.8% (95% CI: 99.5–100%), respectively. Turnaround time for positive results was significantly faster on IDN. Conclusion: In our experience, IDN use in symptomatic individuals in walk-in centres is a reliable sensitive alternative to SOC-NAAT without the need for subsequent confirmation of negative results. Such deployment can accelerate contact tracing, reduce the burden on laboratories and increase access to testing.

scholarly journals Performance Evaluation of the SAMBA II SARS-CoV-2 Test for Point-of-Care Detection of SARS-CoV-2

2020 ◽  
Vol 59 (1) ◽  
pp. e01262-20 ◽  
Author(s):  
Sonny M. Assennato ◽  
Allyson V. Ritchie ◽  
Cesar Nadala ◽  
Neha Goel ◽  
Cuijuan Tie ◽  
...  
Keyword(s):  
Public Health ◽  
Infection Control ◽  
Patient Management ◽  
Clinical Performance ◽  
Point Of Care ◽  
Turnaround Time ◽  
Control Measures ◽  
Nucleic Acid Amplification ◽  
Analytical Sensitivity ◽  
Percent Agreement

ABSTRACTNucleic acid amplification for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in respiratory samples is the standard method for diagnosis. The majority of this testing is centralized and therefore has turnaround times of several days. Point-of-care (POC) testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly. The inclusivity and specificity of the Simple AMplification-Based Assay (SAMBA) II SARS-CoV-2 test were determined by both in silico analyses of the primers and probes and wet testing. The SAMBA II SARS-CoV-2 test was evaluated for performance characteristics. Clinical performance was evaluated in residual combined throat/nose swabs and compared to that of the Public Health England real-time PCR assay targeting the RdRp gene. The SAMBA II SARS-CoV-2 test has an analytical sensitivity of 250 copies/ml for detecting two regions of the genome (open reading frame 1ab [ORF1ab] and nucleocapsid protein [N]). The clinical performance was evaluated in 172 residual combined nose/throat swabs provided by the Clinical Microbiology and Public Health Laboratory, Addenbrooke’s Hospital, Cambridge (CMPHL), which showed an estimated positive percent agreement of 98.9% (95% confidence interval [CI], 93.83 to 99.97) and negative percent agreement of 96.4% (95% CI, 89.92 to 99.26) compared to testing by the CMPHL. The data show that the SAMBA II SARS-CoV-2 test performs equivalently to the centralized testing methods, but with a shorter turnaround time of 86 to 101 min. Point-of-care tests such as SAMBA should enable rapid patient management and effective implementation of infection control measures.

Requiem for the STAT Test: Automation and Point of Care Testing

2019 ◽  
Author(s):  
Gurmukh Singh ◽  
Natasha M Savage ◽  
Brandy Gunsolus ◽  
Kellie A Foss
Keyword(s):  
Point Of Care ◽  
Turnaround Time ◽  
Test Automation ◽  
Test Results ◽  
Point Of Care Testing ◽  
Tube System ◽  
Front End ◽  
Laboratory Test Results ◽  
Batch Testing ◽  
Pneumatic Tube System

Abstract Objective Quick turnaround of laboratory test results is needed for medical and administrative reasons. Historically, laboratory tests have been requested as routine or STAT. With a few exceptions, a total turnaround time of 90 minutes has been the usually acceptable turnaround time for STAT tests. Methods We implemented front-end automation and autoverification and eliminated batch testing for routine tests. We instituted on-site intraoperative testing for selected analytes and employed point of care (POC) testing judiciously. The pneumatic tube system for specimen transport was expanded. Results The in-laboratory turnaround time was reduced to 45 minutes for more than 90% of tests that could reasonably be ordered STAT. With rare exceptions, the laboratory no longer differentiates between routine and STAT testing. Having a single queue for all tests has improved the efficiency of the laboratory. Conclusion It has been recognized in manufacturing that batch processing and having multiple queues for products are inefficient. The same principles were applied to laboratory testing, which resulted in improvement in operational efficiency and elimination of STAT tests. We propose that the target for in-laboratory turnaround time for STAT tests, if not all tests, be 45 minutes or less for more than 90% of specimens.

scholarly journals Performance of Abbott ID Now COVID-19 Rapid Nucleic Acid Amplification Test Using Nasopharyngeal Swabs Transported in Viral Transport Media and Dry Nasal Swabs in a New York City Academic Institution

2020 ◽  
Vol 58 (8) ◽  
Author(s):  
Atreyee Basu ◽  
Tatyana Zinger ◽  
Kenneth Inglima ◽  
Kar-mun Woo ◽  
Onome Atie ◽  
...  
Keyword(s):  
New York ◽  
The United States ◽  
Turnaround Time ◽  
Nucleic Acid Amplification ◽  
Molecular Diagnostic ◽  
Sample Type ◽  
Negative Results ◽  
Viral Transport ◽  
Recent Emergence ◽  
Nasal Swabs

ABSTRACT The recent emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has posed formidable challenges for clinical laboratories seeking reliable laboratory diagnostic confirmation. The swift advance of the crisis in the United States has led to Emergency Use Authorization (EUA) facilitating the availability of molecular diagnostic assays without the more rigorous examination to which tests are normally subjected prior to FDA approval. Our laboratory currently uses two real-time reverse transcription-PCR (RT-PCR) platforms, the Roche Cobas SARS-CoV2 and the Cepheid Xpert Xpress SARS-CoV-2. The two platforms demonstrate comparable performances; however, the run times for each assay are 3.5 h and 45 min, respectively. In search for a platform with a shorter turnaround time, we sought to evaluate the recently released Abbott ID Now COVID-19 assay, which is capable of producing positive results in as little as 5 min. We present here the results of comparisons between Abbott ID Now COVID-19 and Cepheid Xpert Xpress SARS-CoV-2 using nasopharyngeal swabs transported in viral transport media and comparisons between Abbott ID Now COVID-19 and Cepheid Xpert Xpress SARS-CoV-2 using nasopharyngeal swabs transported in viral transport media for Cepheid and dry nasal swabs for Abbott ID Now. Regardless of method of collection and sample type, Abbott ID Now COVID-19 had negative results in a third of the samples that tested positive by Cepheid Xpert Xpress when using nasopharyngeal swabs in viral transport media and 45% when using dry nasal swabs.

scholarly journals Clinical evaluation of serial blood processing at point of care

1997 ◽  
Vol 43 (2) ◽  
pp. 360-362 ◽  
Author(s):  
Christopher A Estey ◽  
Robin A Felder
Keyword(s):  
Clinical Performance ◽  
Point Of Care ◽  
Turnaround Time ◽  
University Of Virginia ◽  
Community Based ◽  
Blood Separation ◽  
The North ◽  
Blood Specimens ◽  
The University

Abstract The Axial Separation Module (ASM™), which separates whole-blood specimens serially in Axial Process Containers (APC™), was evaluated for clinical performance at the University of Virginia Health Sciences Center (UVA HSC) in a community-based outpatient laboratory (North Ridge Clinic). We hypothesized that moving the task of blood separation to point of care would reduce specimen turnaround time within the main laboratory. Blood drawn into an APC was separated in the ASM at point of care at the North Ridge Clinic. Blood drawn into a Vacutainer Tube™was separated in a conventional centrifuge at the main laboratory. Turnaround time was calculated for the “chem 17” test from files stored in our laboratory information system. Blood serially separated at point of care yielded turnaround time savings for specimens originating from the North Ridge Clinic. Average turnaround time decreased by 24%. Phlebotomists found no appreciable workload increase from incorporating the ASM as a point-of-care blood separation device. Phlebotomists also found that they could immediately detect hemolysis. We concluded that serial separation at point of care reduces specimen turnaround time at the main laboratory. The ASM/APC was found to be better suited for point-of-care blood separation than a conventional centrifuge. We speculate that immediate blood separation has the potential to improve the quality of analytical results.

scholarly journals Comparison of the Panther Fusion and BD MAX Group B Streptococcus (GBS) Assays for Detection of GBS in Prenatal Screening Specimens

2019 ◽  
Vol 57 (11) ◽  
Author(s):  
Gregory J. Berry ◽  
Fan Zhang ◽  
Ryhana Manji ◽  
Stefan Juretschko
Keyword(s):  
Late Onset ◽  
Clinical Performance ◽  
Group B Streptococcus ◽  
Turnaround Time ◽  
Nucleic Acid Amplification ◽  
Kappa Statistics ◽  
Loading Capacity ◽  
Content Type ◽  
Return Visits ◽  
Group B

ABSTRACT Streptococcus agalactiae or group B Streptococcus (GBS) is the cause of early- and late-onset GBS disease in neonates and can present as septicemia, meningitis, and pneumonia. Our objective was to compare the performance of two FDA-approved nucleic acid amplification tests (NAATs), the Panther Fusion and BD MAX systems, for detection of GBS in vaginal-rectal screening specimens. A total of 510 vaginal-rectal prepartum specimens were tested simultaneously in both NAATs following broth enrichment. Assay agreement was calculated using kappa statistics. Overall agreement between assays was 99.0% (505/510; 95% confidence interval, 0.951 to 0.997; kappa = 0.974). Discordant results were retested with both assays and by standard culture. The assays were also compared for workflow characteristics, including time to first results (TFR), total turnaround time (TAT), number of return visits to load additional specimens, and hands-on time (HoT). Using a standard run size of 60 specimens/day, the Panther Fusion assay had a longer TFR (2.4 versus 2.0 h) but showed a shorter overall TAT for all 60 samples (3.98 versus 7.18 h) due to an increased initial sample loading capacity, and it required less labor (35.0 versus 71.3 s/sample) and fewer return visits for loading additional specimens (0 versus 2). The Panther Fusion system also had a larger sample loading capacity (120 versus 24 samples) and greater 8-h throughput (335 versus 96 samples). In summary, the Panther Fusion GBS assay has clinical performance comparable to that of the BD MAX GBS assay but provides a faster TAT, less HoT, and higher throughput.

scholarly journals ASSESSMENT OF PERFORMANCE AND IMPLEMENTATION CHARACTERISTICS OF RAPID POINT OF CARE SARS-CoV-2 ANTIGEN TESTING IN KENYA

2021 ◽  
Author(s):  
Jesse Gitaka ◽  
Eva Muthamia ◽  
Samuel Mbugua ◽  
Mary Mungai ◽  
Gama Bandawe ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Test Performance ◽  
Gold Standard ◽  
Point Of Care ◽  
Turnaround Time ◽  
Ease Of Use ◽  
Control Measures ◽  
Antigen Test ◽  
Rt Pcr ◽  
Predictive Values

Abstract Background: The COVID-19 pandemic has resulted in a need for rapid identification of infectious cases. Testing barriers have prohibited adequate screening for SARS COV2, resulting in significant delays in treatment provision and commencement of outbreak control measures. This study aimed to generate evidence on the performance and implementation characteristics of the BD Veritor rapid antigen test as compared to the gold standard test for diagnosis of SARS COV2 in Kenya. Methods: This was a field test performance evaluation in symptomatic and asymptomatic adults undergoing testing for SARS COV2. Recruited participants were classified as SARS-CoV2-positive based on the locally implemented gold standard reverse transcription polymerase chain reaction (RT-PCR) test performed on nasopharyngeal swabs. 272 antigen tests were performed with simultaneous gold standard testing, allowing us to estimate sensitivity, specificity, positive and negative predictive values for the BD Veritor rapid antigen test platform. Implementation characteristics were assessed using the Consolidated Framework for Implementation Research for feasibility, acceptability, turn-around time, and ease-of-use metrics. Results and Discussion: We enrolled 97 PCR negative symptomatic and 128 PCR negative asymptomatic, and 28 PCR positive symptomatic and 19 PCR positive asymptomatic participants. Compared to the gold standard, the sensitivity of the BD Veritor antigen test was 94% (95% confidence interval [CI] 86.6 to 100.0) while the specificity was 98% (95% confidence interval [CI] 96 to 100). The sensitivity of BD Veritor antigen test was higher among symptomatic (100%) compared to asymptomatic (84%) participants, although this difference was not statistically significant. There was also a lack of association between cycle threshold value and sensitivity of BD Veritor test. The BD Veritor test had quick turnaround time and minimal resource requirements, and laboratory personnel conducting testing felt that it was easier to use than the gold standard RT-PCR. Conclusion: The BD Veritor rapid antigen test exhibited excellent sensitivity and specificity when used to detect SARS-CoV-2 infection among both symptomatic and asymptomatic individuals in varied population settings in Kenya. It was feasible to implement and easy to use, with rapid turnaround time.

scholarly journals Diagnostic testing for feline panleukopenia in a shelter setting: a prospective, observational study

2021 ◽  
pp. 1098612X2110053
Author(s):  
Linda S Jacobson ◽  
Kyrsten J Janke ◽  
Jolene Giacinti ◽  
J Scott Weese
Keyword(s):  
Point Of Care ◽  
Diagnostic Testing ◽  
False Negative ◽  
Clinical Signs ◽  
Test Results ◽  
Feline Panleukopenia Virus ◽  
Negative Results ◽  
Copy Numbers ◽  
Rectal Swabs ◽  
Vaccination History

Objectives The aim of this study was to optimize the diagnosis of feline panleukopenia virus (FPV) in a shelter setting by: (1) comparing the results of the canine parvovirus IDEXX SNAP Parvo (SNAP) point-of-care ELISA with a commercial FPV quantitative real-time PCR (qPCR) test; (2) assessing whether vomit and anal/rectal swabs could be used for early diagnosis; and (3) clarifying the interpretation of weak-positive SNAP test results. Methods The study included shelter cats and kittens with incomplete or unknown vaccination history that had clinical signs suspicious for feline panleukopenia and fecal SNAP and PCR tests performed within 24 h of onset. Feces, anal/rectal swabs and vomit were tested using SNAP and PCR, with fecal PCR utilized as the reference standard. Results One hundred and forty-five cats were included. Seventeen were diagnosed with FPV infection and 62 were negative; 66 could not be individually designated because they were co-housed. Sensitivity was as follows: fecal SNAP 55% (n = 102; 95% confidence interval [CI] 32–77); swab SNAP 30% (n = 55; 95% CI 7–65); swab PCR 77% (n = 55; 95% CI 46–95); and vomit PCR 100% (n = 17; 95% CI 16–100). Specificity was high (96–100%) for all sample and test types. For PCR-positive fecal samples, true-positive SNAP tests (including weak positives) had significantly higher DNA viral copy numbers than false-negative SNAP tests ( P = 0.0031). Conclusions and relevance The SNAP ELISA should be viewed as an initial diagnostic test to rule in feline panleukopenia. Positive fecal SNAP test results, including weak positives, are highly likely to be true positives in clinically affected animals. Negative results in clinically affected animals are unreliable and should be followed up with PCR testing.

scholarly journals The “3 in 1” Study: Pooling Self-Taken Pharyngeal, Urethral, and Rectal Samples into a Single Sample for Analysis for Detection of Neisseria gonorrhoeae and Chlamydia trachomatis in Men Who Have Sex with Men

2015 ◽  
Vol 54 (3) ◽  
pp. 650-656 ◽  
Author(s):  
B. Sultan ◽  
J. A. White ◽  
R. Fish ◽  
G. Carrick ◽  
N. Brima ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Standard Of Care ◽  
Nucleic Acid Amplification ◽  
Site Testing ◽  
Predictive Values ◽  
Content Type ◽  
Sexually Transmitted ◽  
Soc Testing ◽  
Sex With Men

Triple-site testing (using pharyngeal, rectal, and urethral/first-void urine samples) forNeisseria gonorrhoeaeandChlamydia trachomatisusing nucleic acid amplification tests detects greater numbers of infections among men who have sex with men (MSM). However, triple-site testing represents a cost pressure for services. MSM over 18 years of age were eligible if they requested testing for sexually transmitted infections (STIs), reported recent sexual contact with eitherC. trachomatisorN. gonorrhoeae, or had symptoms of an STI. Each patient underwent standard-of-care (SOC) triple-site testing, and swabs were taken to form a pooled sample (PS) (pharyngeal, rectal, and urine specimens). The PS was created using two methods during different periods at one clinic, but we analyzed the data in combination because the sensitivity of the two methods did not differ significantly forC. trachomatis(P= 0.774) orN. gonorrhoeae(P= 0.163). The sensitivity of PS testing (92%) was slightly lower than that of SOC testing (96%) for detectingC. trachomatis(P= 0.167). ForN. gonorrhoeae, the sensitivity of PS testing (90%) was significantly lower than that of SOC testing (99%) (P< 0.001). When pharynx-only infections were excluded, the sensitivity of PS testing to detectN. gonorrhoeaeinfections increased to 94%. Our findings show that pooling of self-taken samples could be an effective and cost-saving method, with high negative predictive values. (Interim results of this study were presented at the BASHH 2013 summer meeting.)

scholarly journals 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.

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.

scholarly journals iSCAN: An RT-LAMP-coupled CRISPR-Cas12 module for rapid, sensitive detection of SARS-CoV-2

2020 ◽  
Author(s):  
Zahir Ali ◽  
Rashid Aman ◽  
Ahmed Mahas ◽  
Gundra Sivakrishna Rao ◽  
Muhammad Tehseen ◽  
...  
Keyword(s):  
Point Of Care ◽  
Human Life ◽  
Virus Detection ◽  
Turnaround Time ◽  
Nucleic Acid Amplification ◽  
Molecular Diagnostic ◽  
Amplification Method ◽  
Single Temperature ◽  
User Friendly ◽  
And Control

AbstractThe COVID-19 pandemic caused by SARS-CoV-2 affects all aspects of human life. Detection platforms that are efficient, rapid, accurate, specific, sensitive, and user friendly are urgently needed to manage and control the spread of SARS-CoV-2. RT-qPCR based methods are the gold standard for SARS-CoV-2 detection. However, these methods require trained personnel, sophisticated infrastructure, and a long turnaround time, thereby limiting their usefulness. Reverse transcription-loop-mediated isothermal amplification (RT-LAMP), a one-step nucleic acid amplification method conducted at a single temperature, has been used for colorimetric virus detection. CRISPR-Cas12 and CRISPR-Cas13 systems, which possess collateral activity against ssDNA and RNA, respectively, have also been harnessed for virus detection. Here, we built an efficient, rapid, specific, sensitive, user-friendly SARS-CoV-2 detection module that combines the robust virus amplification of RT-LAMP with the specific detection ability of SARS-CoV-2 by CRISPR-Cas12. Furthermore, we combined the RT-LAMP-CRISPR-Cas12 module with lateral flow cells to enable highly efficient point-of-care SARS-CoV-2 detection. Our iSCAN SARS-CoV-2 detection module, which exhibits the critical features of a robust molecular diagnostic device, should facilitate the effective management and control of COVID-19.

Sign in / Sign up

Export Citation Format

Share Document