scholarly journals Dramatic impact of rapid point of care nucleic acid testing for SARS-CoV-2 in hospitalised patients: a clinical validation trial and implementation study

2020 ◽  
Author(s):  
Dami Collier ◽  
Sonny M. Assennato ◽  
Ben Warne ◽  
Nyarie Sithole ◽  
Katherine Sharrocks ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Emergency Room ◽  
Throat Swab ◽  
Point Of Care ◽  
Turnaround Time ◽  
Implementation Study ◽  
Central Laboratory ◽  
Pilot Phase ◽  
Rt Pcr ◽  
Implementation Phase

AbstractBackgroundThere is urgent need for safe and efficient triage protocols for hospitalized COVID-19 suspects to appropriate isolation wards. A major barrier to timely discharge of patients from the emergency room and hospital is the turnaround time for many SARS-CoV-2 nucleic acid tests. We validated a point of care nucleic acid amplification based platform SAMBA II for diagnosis of COVID-19 and performed an implementation study to assess its impact on patient disposition at a major academic hospital.MethodsWe prospectively recruited COVID-19 suspects admitted to hospital (NCT04326387). In an initial pilot phase, individuals were tested using a nasal/throat swab with the SAMBA II SARS-CoV-2 rapid diagnostic platform in parallel with a combined nasal/throat swab for standard central laboratory RT-PCR testing. In the second implementation phase, we examined the utility of adding the SAMBA platform to routine care. In the pilot phase, we measured concordance and assay validity using the central laboratory as the reference standard and assessed assay turnaround time. In the implementation phase, we assessed 1) time to definitive bed placement from admission, 2) time spent on COVID-19 holding wards, 3) proportion of patients in isolation versus COVID negative areas following a test, comparing the implementation phase with the 10 days prior to implementation.ResultsIn phase I, 149 participants were included in the pilot. By central laboratory RT-PCR testing, 32 (21.5%) tested positive and 117 (78.5%). Sensitivity and specificity of the SAMBA assay compared to RT-PCR lab test were 96.9% (95% CI 0.838-0.999) and 99.1% (0.953-0.999), respectively. Median time to result was 2.6 hours (IQR 2.3 to 4.8) for SAMBA II SARS-CoV-2 test and 26.4 hours (IQR 21.4 to 31.4) for the standard lab RT-PCR test (p<0.001). In the first 10 days of the SAMBA implementation phase, we conducted 992 tests, with the majority (59.8%) used for hospital admission, and the remainder for pre-operative screening (11.3%), discharge planning (10%), in-hospital screening of new symptoms (9.7%). Comparing the pre-implementation (n=599) with the implementation phase, median time to definitive bed placement from admission was reduced from 23.4 hours (8.6-41.9) to 17.1 hours (9.0-28.8), P=0.02 in Cox analysis, adjusted for age, sex, comorbidities and clinical severity at presentation. Mean length of stay on a COVID-19 ‘holding’ ward decreased from 58.5 hours to 29.9 hours (P<0.001). Use of single occupancy rooms amongst those tested fell from 30.8% before to 21.2% (P=0.03) and 11 hospital bay closures (on average 6 beds each) were avoided after implementation of the POC assay.ConclusionsThe SAMBA II SARS-CoV-2 rapid assay performed well compared to a centralized laboratory RT-PCR platform and demonstrated shorter time to result both in trial and real-world settings. It was also associated with faster time to definitive bed placement from the emergency room, greater availability of isolation rooms, avoidance of hospital bay closures, and greater movement of patients to COVID negative open “green” category wards. Rapid testing in hospitals has the potential to transform ability to deal with the COVID-19 epidemic.

scholarly journals COVID-19 Biomarkers and Advanced Sensing Technologies for Point-of-Care (POC) Diagnosis

2021 ◽  
Vol 8 (7) ◽  
pp. 98
Author(s):  
Ernst Emmanuel Etienne ◽  
Bharath Babu Nunna ◽  
Niladri Talukder ◽  
Yudong Wang ◽  
Eon Soo Lee
Keyword(s):  
Response Times ◽  
Rna Virus ◽  
Point Of Care ◽  
Protein Detection ◽  
Turnaround Time ◽  
Quantitative Detection ◽  
Rt Pcr ◽  
Specificity And Sensitivity ◽  
Small Market ◽  
Multiple Biomarkers

COVID-19, also known as SARS-CoV-2 is a novel, respiratory virus currently plaguing humanity. Genetically, at its core, it is a single-strand positive-sense RNA virus. It is a beta-type Coronavirus and is distinct in its structure and binding mechanism compared to other types of coronaviruses. Testing for the virus remains a challenge due to the small market available for at-home detection. Currently, there are three main types of tests for biomarker detection: viral, antigen and antibody. Reverse Transcription-Polymerase Chain Reaction (RT-PCR) remains the gold standard for viral testing. However, the lack of quantitative detection and turnaround time for results are drawbacks. This manuscript focuses on recent advances in COVID-19 detection that have lower limits of detection and faster response times than RT-PCR testing. The advancements in sensing platforms have amplified the detection levels and provided real-time results for SARS-CoV-2 spike protein detection with limits as low as 1 fg/mL in the Graphene Field Effect Transistor (FET) sensor. Additionally, using multiple biomarkers, detection levels can achieve a specificity and sensitivity level comparable to that of PCR testing. Proper biomarker selection coupled with nano sensing detection platforms are key in the widespread use of Point of Care (POC) diagnosis in COVID-19 detection.

scholarly journals Challenges to Glycemic Measurement in the Perioperative and Critically Ill Patient: A Review

2009 ◽  
Vol 3 (6) ◽  
pp. 1270-1281 ◽  
Author(s):  
Andrew D. Pitkin ◽  
Mark J. Rice
Keyword(s):  
Point Of Care ◽  
Turnaround Time ◽  
Sample Volume ◽  
Hospital Environment ◽  
Glucose Measurement ◽  
Critically Ill Patient ◽  
Central Laboratory ◽  
Patients With Diabetes ◽  
Measurement Devices ◽  
Glucose Management

Accurate monitoring of glucose in the perioperative environment has become increasingly important over the last few years. Because of increased cost, turnaround time, and sample volume, the use of central laboratory devices for glucose measurement has been somewhat supplanted by point-of-care (POC) glucose devices. The trade-off in moving to these POC systems has been a reduction in accuracy, especially in the hypoglycemic range. Furthermore, many of these POC devices were originally developed, marketed, and received Food and Drug Administration regulatory clearance as home use devices for patients with diabetes. Without further review, many of these POC glucose measurement devices have found their way into the hospital environment and are used frequently for measurement during intense insulin therapy, where accurate measurements are critical. This review covers the technology behind glucose measurement and the evidence questioning the use of many POC devices for perioperative glucose management.

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 Continued nucleic acid tests for SARS-CoV-2 following discharge of patients with COVID-19 in Lu’an, China

PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e11617
Author(s):  
Yong Lyu ◽  
Danni Wang ◽  
Xiude Li ◽  
Tianqi Gong ◽  
Pengpeng Xu ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Throat Swab ◽  
Nucleic Acid Testing ◽  
Rt Pcr ◽  
Positive Group ◽  
The Third ◽  
Anal Swab ◽  
Discharge Criteria ◽  
Pcr Test

Background Studies have shown that discharged Coronavirus disease 2019 (COVID-19) patients have retested positive for SARS-CoV-2 during a follow-up RT-PCR test. We sought to assess the results of continued nucleic acid testing for SARS-CoV-2 patients in COVID-19 patients after they were discharged in Lu’an, China. Methods We conducted RT-PCR tests on sputum, throat swabs, fecal or anal swabs, and urine samples collected from 67 COVID-19 patients following discharge. Samples were collected on the 7th and 14th days following discharge. Patients testing positive on the 7th or 14th day were retested after 24 hours until they tested negative twice. Results Seventeen (17/67, 25.4%) discharged COVID-19 patients had a positive RT-PCR retest for SARS-CoV-2. Among them, 14 (82.4%) were sputum positive, five (29.4%) were throat swab positive, seven (41.2%) were fecal or anal swab positive, one (5.9%) was urine sample positive, five (29.4%) were both sputum and throat swab positive, four (23.5%) were both sputum and fecal test positive, and one (5.9%) was positive of all four specimens. The shortest period of time between discharge and the last positive test was 7 days, the longest was 48 days, and the median was 16 days. The proportion of positive fecal or anal swab tests increased from the third week. The median Cq cut-off values after onset were 26.7 after the first week, 37.7 the second to sixth week, and 40 after the sixth week. There were no significant differences between the RT-PCR retest positive group and the unrecovered positive group. Conclusions There was a high proportion of patients who retested positive for COVID-19. Discharge criteria have remained fairly consistent so we encourage regions affected by COVID-19 to appropriately amend their current criteria.

scholarly journals Comparative Study of the Efficacy of the Abbott ID Now Rapid Assay with Real Time PCR for the Diagnosis of SARS-CoV-2 RNA

2021 ◽  
Author(s):  
Pratiksha Chheda ◽  
Dama Tavisha ◽  
Bhalerao Rahul ◽  
Bagwan Jamir ◽  
Bhat Devdatta ◽  
...  
Keyword(s):  
Real Time ◽  
Point Of Care ◽  
Turnaround Time ◽  
Rt Pcr ◽  
Pcr Assay ◽  
Clinical Patient ◽  
Point Of Care Test ◽  
Percent Agreement ◽  
Current Outbreak ◽  
Spread Of Infection

Abstract Rapid diagnostic tests are of great importance in hospital settings during the current outbreak of SARS-CoV-2. The clinical patient management and spread of infection is critically dependent on molecular assays with shortest possible turn-around time. Here we report performance of a point of care Abbott ID NOW COVID-19 assay in comparison to routinely used real-time RT-PCR assay on 205 clinical specimens. Overall agreement of ID NOW was found to be 93.7% with positive percent agreement (PPA) of 91.8% and negative percent agreement (NPA) of 95.4%. Based on our findings, low turnaround time, minimal infrastructure need and ease of performing the assay, Abbott ID NOW COVID-19 assay can be considered as a point of care test in hospital settings.

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

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.

scholarly journals Clinical Analysis on Diagnostic Accuracy of Bosch Vivalytic SARS- CoV-2 Point-of-Care Test and Evaluation of Cycle Threshold at Admission for COVID-19 Risk Assessment

2021 ◽  
Author(s):  
Lukas Andreas Heger ◽  
Nils Elsen ◽  
Marina Rieder ◽  
Nadine Gauchel ◽  
Urte Sommerwerck ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Point Of Care ◽  
Length Of Hospital Stay ◽  
Turnaround Time ◽  
Clinical Analysis ◽  
Rt Pcr ◽  
Real World Data ◽  
Clinical Sensitivity ◽  
Cycle Threshold ◽  
Point Of Care Test

Abstract Background Point-of-care (POC) polymerase chain reaction (PCR) tests have the ability to improve testing efficiency in the Coronavirus disease 2019 (COVID-19) pandemic. However, real-world data on POC tests is scarce.Objective To evaluate the efficiency of a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) POC test in a clinical setting and examine the prognostic value of on admission cycle threshold (CT) on length of hospital stay (LOS) in COVID-19 patients.Methods Patients hospitalised between January and May 2021 were included in this prospective cohort study. Patients’ nasopharyngeal swabs were tested for SARS-CoV-2 with Allplex™2019-nCoV (Seegene Inc.) real-time (RT) PCR assay and novel POC test (Bosch Vivalytic SARS-CoV-2 [Bosch]) as well as the SARS-CoV-2 Rapid Antigen Test (Roche) accordingly. Clinical sensitivity and specificity as well as inter- and intra-assay variability were analysed. Results 120 patients met the inclusion criteria with 46 (38%) having definite COVID-19 diagnose by RT-PCR. Bosch Vivalytic SARS-CoV-2 POC had a sensitivity of 88% and specificity of 96%. The inter- and intra- assay variability was below 15%. CT Value at baseline was lower in patients with LOS ≥10 days when compared to patients with LOS <10 days (27.82 (±4.648) vs. 36.2 (25.9 - 39.18); p=0.0191). There was a negative correlation of CT at admission and LOS (r[44]s= -.31; p=0.038)Conclusion Our data indicate that POC testing with Bosch Vivalytic SARS-CoV-2 is a valid strategy to identify COVID-19 patients and decrease turnaround time to definite COVID-19 diagnosis. Also our data suggests at admission CT as promising marker for length of hospital stay and possibly severity of disease in COVID-19 patients.

scholarly journals Multicenter Clinical Evaluation of the Alere i Respiratory Syncytial Virus Isothermal Nucleic Acid Amplification Assay

2017 ◽  
Vol 56 (3) ◽  
Author(s):  
Ferdaus Hassan ◽  
Lindsay M. Hays ◽  
Aleta Bonner ◽  
Bradley J. Bradford ◽  
Ruffin Franklin ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Nucleic Acid ◽  
Care Setting ◽  
Point Of Care ◽  
Nucleic Acid Amplification ◽  
Rt Pcr ◽  
Pcr Assay ◽  
Isothermal Nucleic Acid Amplification ◽  
Syncytial Virus ◽  
Respiratory Specimens

ABSTRACTThe Alere i respiratory syncytial virus (RSV) assay is an isothermal nucleic acid amplification test capable of detecting RSV directly from respiratory specimens, with results being available in ≤13 min after test initiation. The objective of this study was to evaluate the performance characteristics of the Alere i RSV assay in a point-of-care setting by using direct nasopharyngeal (NP) swab specimens (direct NP) and nasopharyngeal swab specimens eluted and transported in viral transport medium (VTM NP). The study was a prospective, multicenter, clinical trial conducted at 9 sites across the United States to evaluate the clinical performance of the Alere i RSV assay with respiratory specimens obtained from both children (age, <18 years) and older adults (age, >60 years). The performance of the Alere i RSV assay was compared with that of the reference method, the Prodesse ProFlu+ real-time reverse transcriptase PCR (RT-PCR) assay. All specimens with discrepant test results were tested further by a second FDA-cleared PCR assay (the Verigene respiratory virus plus nucleic acid test; Luminex Inc., TX). A total of 554 subjects with signs and symptoms of respiratory infections were enrolled, and respiratory samples were collected in this study. In comparison with the ProFlu+ real-time RT-PCR, the overall sensitivity and specificity of Alere i RSV assay for the detection of RSV were 98.6% (95% confidence interval [CI], 94.4 to 99.7%) and 98.0% (95% CI, 95.8 to 99.1%), respectively, for direct NP and 98.6% (95% CI, 94.4 to 99.7%) and 97.8% (95% CI, 95.5 to 98.9%), respectively, for VTM NP. The Alere i RSV is a highly sensitive and specific molecular assay ideal for rapid RSV detection in patients in the point-of-care setting due to its minimal hands-on time and rapid result availability.

scholarly journals Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study

2020 ◽  
Vol 1 (5) ◽  
pp. 100062 ◽  
Author(s):  
Dami A. Collier ◽  
Sonny M. Assennato ◽  
Ben Warne ◽  
Nyarie Sithole ◽  
Katherine Sharrocks ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Point Of Care ◽  
Hospitalized Patients ◽  
Clinical Validation ◽  
Nucleic Acid Testing ◽  
Implementation Study

Point-of-care versus central laboratory coagulation testing during haemorrhagic surgery

2009 ◽  
Vol 101 (02) ◽  
pp. 394-401 ◽  
Author(s):  
Yves Ozier ◽  
Annick Ankri ◽  
Marie-Hélène Fléron ◽  
Geneviève Leroux ◽  
Charles Marc Samama ◽  
...  
Keyword(s):  
Surgical Procedure ◽  
Point Of Care ◽  
Turnaround Time ◽  
Fresh Frozen Plasma ◽  
Blood Collection ◽  
Test Results ◽  
Central Laboratory ◽  
Coagulation Testing ◽  
Critical Issues ◽  
Fresh Frozen

SummaryDelay in collecting coagulation test results from a central laboratory is one of the critical issues to efficiently control haemostasis during surgery. The aim of this multicenter study was to compare the performance of a point-of-care (POC) device (CoaguChek™ Pro DM) with the central laboratory-based coagulation testing during haemorrhagic surgery. For this purpose, 93 patients undergoing major surgical procedure were prospectively included in three centers. Blood was drawn from all patients before surgical incision and from most patients during surgical procedure after a blood loss of 25% or more was observed. When expressed in activity percentage, POC-based prothrombin time (PT) was in good agreement with central laboratory test result with coefficient of correlation in the range from 0.711 to 0.960 in the three centers. Comparison was less conclusive when PT was expressed in seconds or as the patient-to-control ratio and for activated partial thromboplastin time, with significantly shorter clotting times and lower ratios obtained on the POC device. On-site PT (in activity percentage) monitoring would have induced no significant change in fresh frozen plasma (FFP) transfusion in patients when compared to central laboratory monitoring. Test results were obtained in less than 5 minutes when performed using the POC device versus a median turnaround time of 88 minutes (range: 29–235 minutes) when blood collection tubes were sent to the central laboratory. These results suggest that, in providing a rapid answer, POC-based monitoring of PT (in percentage) using the CoaguChek device could be validly used in patients undergoing haemorrhagic surgical procedures.

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