scholarly journals Validation of a Novel IoT and AI based Point-of-Care Testing Laboratory: Analytical Accuracy and Clinical Agreement

2021 ◽  
Author(s):  
Lucca Malucelli ◽  
Gabriele Luise Neves Alves ◽  
Carolina Melchioretto dos Santos ◽  
Matheus Severo ◽  
Victor Henrique Alves Ribeiro ◽  
...  
Keyword(s):  
Influenza A ◽  
Point Of Care ◽  
Pearson Correlation ◽  
Turnaround Time ◽  
Clinical Samples ◽  
Point Of Care Testing ◽  
Reliable Performance ◽  
25 Hydroxy Vitamin D ◽  
Analytical Accuracy ◽  
Kappa Agreement

Point-of-care testing (POCT) offers several advantages over traditional laboratory testing. Offering less invasive testing with a faster turnaround time is not enough if not associated with an acceptable level of accuracy. Here, we show the analytical validation behind the multi-analyte POCT immunochromatography analyser, Hilab Flow (HiF). Analyses from 4,518 clinical samples were compared to College of American Pathologists accredited laboratories for ten quantitative and thirteen qualitative exams. Compatibility between methods was evaluated in terms of association/correlation and clinical agreement. Strong correlation/ concordance was observed between quantitative (CHOL, HDL-c, TG, HbA1c, Glycemia, 25-Hydroxy Vitamin D, TSH, Uric Acid, Creatinine, Urea) and qualitative methods (COVID-19 IgG/ IgM, Beta-hCG, Syphilis, Anti-HBsAg, Zika IgG/ IgM, Influenza A/B, HIV, HCV, HBsAg, Dengue NS1, COVID-19 Ag, Dengue IgG/ IgM, PSA). Approval criteria was obtaining a kappa agreement > 0.8 or a Pearson correlation > 0.9 depending on the exam. Overall percentage agreement was greater than 95% for all exams, indicating a good clinical agreement to gold-standard laboratory-based tests. Results indicate all exams are suitable for POCT and present a reliable performance. Data support the analyser is a useful tool to aid decision-making at the clinical setting, with potential to contribute with healthcare solutions in diagnostic medicine worldwide.

scholarly journals Evaluation of mobile real-time polymerase chain reaction tests for the detection of severe acute respiratory syndrome coronavirus 2

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Chukwunonso Onyilagha ◽  
Henna Mistry ◽  
Peter Marszal ◽  
Mathieu Pinette ◽  
Darwyn Kobasa ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Real Time ◽  
Point Of Care ◽  
Middle Eastern ◽  
Turnaround Time ◽  
Cross Reactivity ◽  
Clinical Samples ◽  
Diarrhea Virus ◽  
Highly Sensitive ◽  
Transmissible Gastroenteritis

AbstractThe coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), calls for prompt and accurate diagnosis and rapid turnaround time for test results to limit transmission. Here, we evaluated two independent molecular assays, the Biomeme SARS-CoV-2 test, and the Precision Biomonitoring TripleLock SARS-CoV-2 test on a field-deployable point-of-care real-time PCR instrument, Franklin three9, in combination with Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0 (M1) manual extraction system for rapid, specific, and sensitive detection of SARS-COV-2 in cell culture, human, and animal clinical samples. The Biomeme SARS-CoV-2 assay, which simultaneously detects two viral targets, the orf1ab and S genes, and the Precision Biomonitoring TripleLock SARS-CoV-2 assay that targets the 5′ untranslated region (5′ UTR) and the envelope (E) gene of SARS-CoV-2 were highly sensitive and detected as low as 15 SARS-CoV-2 genome copies per reaction. In addition, the two assays were specific and showed no cross-reactivity with Middle Eastern respiratory syndrome coronavirus (MERS-CoV), infectious bronchitis virus (IBV), porcine epidemic diarrhea virus (PEDV), transmissible gastroenteritis (TGE) virus, and other common human respiratory viruses and bacterial pathogens. Also, both assays were highly reproducible across different operators and instruments. When used to test animal samples, both assays equally detected SARS-CoV-2 genetic materials in the swabs from SARS-CoV-2-infected hamsters. The M1 lysis buffer completely inactivated SARS-CoV-2 within 10 min at room temperature enabling safe handling of clinical samples. Collectively, these results show that the Biomeme and Precision Biomonitoring TripleLock SARS-CoV-2 mobile testing platforms could reliably and promptly detect SARS-CoV-2 in both human and animal clinical samples in approximately an hour and can be used in remote areas or health care settings not traditionally serviced by a microbiology laboratory.

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 evaluation of the point-of-care SAMBA II SARS-CoV-2 Test for detection of SARS-CoV-2

2020 ◽  
Author(s):  
Sonny M Assennato ◽  
Allyson V Ritchie ◽  
Cesar Nadala ◽  
Neha Goel ◽  
Hongyi Zhang ◽  
...  
Keyword(s):  
Public Health ◽  
Infection Control ◽  
Sensitivity And Specificity ◽  
Patient Management ◽  
Limit Of Detection ◽  
Point Of Care ◽  
Clinical Samples ◽  
Analytical Sensitivity ◽  
Point Of Care Testing ◽  
Clinical Sensitivity

AbstractNucleic acid amplification for the detection of SARS-CoV-2 RNA in respiratory samples is the standard method for diagnosis. These tests are centralised and therefore turnaround times can be 2-5 days. Point-of-care testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly.Inclusivity and specificity of the SAMBA II SARS-CoV-2 assay was determined by in silico analyses of the primers and probes. Analytical and clinical sensitivity and specificity of the SAMBA II SARS-CoV-2 Test was evaluated for analytical sensitivity and specificity. Clinical performance was evaluated in residual clinical samples compared to the Public Health England reference tests.The limit of detection of the SAMBA II SARS-CoV-2 Test is 250 cp/mL and is specific for detection of 2 regions of the SARS-CoV-2 genome. The clinical sensitivity was evaluated in 172 clinical samples provided by the Clinical Microbiology and Public Health Laboratory, Addenbrooke’s Hospital, Cambridge (CMPHL), which showed a sensitivity of 98.9% (95% CI 94.03-99.97%), specificity of 100% (95% CI 95.55-100%), PPV of 100% and NPV of 98.78% (92.02-99.82%) compared to testing by CMPHLSAMBA detected 3 positive samples that were initially negative by PHE Test. The data shows that the SAMBA II SARS-CoV-2 Test performs equivalently to the centralised testing methods with a much quicker turnaround time. Point of care testing, such as SAMBA, should enable rapid patient management and effective implementation of infection control measures.

scholarly journals Molecular point-of-care testing for influenza A/B and respiratory syncytial virus: comparison of workflow parameters for the ID Now and cobas Liat systems

2019 ◽  
Author(s):  
Stephen Young ◽  
Jamie Phillips ◽  
Christen Griego-Fullbright ◽  
Aaron Wagner ◽  
Patricia Jim ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Influenza A ◽  
Point Of Care ◽  
Turnaround Time ◽  
Walk Away ◽  
Molecular Tests ◽  
Syncytial Virus ◽  
Improve Patient Management ◽  
Parallel Workflow ◽  
Improve Patient

ABSTRACTAimsPoint-of-care (POC) tests for influenza and respiratory syncytial virus (RSV) offer the potential to improve patient management and antimicrobial stewardship. Studies have focused on performance; however, no workflow assessments have been published comparing POC molecular tests. This study compared the Liat and ID Now systems workflow, to assist end-users in selecting an influenza and/or RSV POC test.MethodsStaffing, walk-away, and turnaround time (TAT) of the Liat and ID Now systems were determined using 40 nasopharyngeal samples, positive for influenza or RSV. The ID Now system requires separate tests for influenza and RSV, so parallel (two instruments) and sequential (one instrument) workflows were evaluated.ResultsThe ID Now ranged 4.1–6.2 minutes for staffing, 1.9–10.9 minutes for walk-away and 6.4–15.8 minutes for TAT per result. The Liat ranged 1.1–1.8 minutes for staffing, 20.0–20.5 minutes for walk-away and 21.3–22.0 minutes for TAT. Mean walk-away time comprised 38.0% (influenza positive) and 68.1% (influenza negative) of TAT for ID Now and 93.7% (influenza/RSV) for Liat. The ID Now parallel workflow resulted in medians of 5.9 minutes for staffing, 9.7 minutes for walk-away, and 15.6 minutes for TAT. Assuming prevalence of 20% influenza and 20% RSV, the ID Now sequential workflow resulted in medians of 9.4 minutes for staffing, 17.4 minutes for walk-away, and 27.1 minutes for TAT.ConclusionsThe ID Now and Liat systems offer different workflow characteristics. Key considerations for implementation include value of both influenza and RSV results, clinical setting, staffing capacity, and instrument(s) placement.

Cost-effectiveness and Laboratory Turnaround Time using Expanded Point-of-Care Testing in the ICU

1999 ◽  
Vol 27 (Supplement) ◽  
pp. 115A ◽  
Author(s):  
Karen K. Giuliano ◽  
Thomas L. Higgins ◽  
Eileen Pysznik ◽  
William McGee ◽  
Sue Perkins ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Point Of Care ◽  
Turnaround Time ◽  
Point Of Care Testing

scholarly journals Performances of NeuMoDx, a random-access system for HBV-DNA and HCV-RNA quantification

2020 ◽  
Author(s):  
Juliette Besombes ◽  
Charlotte Pronier ◽  
Charles Lefevre ◽  
Gisèle Lagathu ◽  
Anne Maillard ◽  
...  
Keyword(s):  
Internal Control ◽  
Random Access ◽  
Turnaround Time ◽  
Correlation Factor ◽  
Hbv Dna ◽  
Clinical Samples ◽  
Hcv Rna ◽  
Rna Quantification ◽  
Kappa Agreement ◽  
Serial Dilutions

AbstractViral loads (VL) monitoring for hepatitis B and C is essential to evaluate disease progression and treatment response. Automated, random-access rapid systems are becoming standard to provide reliable VL to clinicians. The aim of this study was to evaluate the analytical performances of the recently launched NeuMoDx™ for HBV-DNA and HCV-RNA quantification. Clinical samples routinely quantified on the Beckman-Veris system were either retrospectively (frozen samples; HBV n=178, HCV n=249), or in parallel (fresh primary tubes; HBV n=103, HCV n=124) tested using NeuMoDx™. Linearity range was assessed on serial dilutions of high tittered plasmas containing different genotypes for HBV (A-E, n=10) and HCV (1a-b, 2-5, n=12). Overall test failure, mostly internal control amplification failure, was 2.3% and was not influenced by matrix types. For HBV-VL, Kappa agreement was 74%, with 27 (12.6%) discrepancies. Correlation between HBV assays on 72 quantified samples by both methods was excellent (r=0.963) with a mean bias (NeuMoDx™-Veris) of 0.21 log IU/mL. For HCV-VL, Kappa agreement reached 94%, with 9 (2.8%) discrepancies. The r-correlation factor between assays on 104 samples was 0.960 with a mean bias of −0.14 log IU/mL (NeuMoDx™-Veris). Serial dilutions confirmed the claimed linear ranges for all HBV and HCV genotypes. The mean turnaround time was 72’ [55-101] for HBV and 96’ [78-133] for HCV. These results obtained on the NeuMoDx™ confirmed the overall good functionality of the system with a short turn-around-time, full traceability and easy handling. These results on HBV- and HCV-VL look promising and should be challenged with further comparisons.

scholarly journals PENILAIAN UJI TROPONIN I DENGAN POINT OF CARE TESTING

2018 ◽  
Vol 22 (2) ◽  
pp. 114
Author(s):  
Sheila Febriana ◽  
Asvin Nurulita ◽  
Uleng Bahrun
Keyword(s):  
Whole Blood ◽  
Clinical Condition ◽  
Troponin I ◽  
Task Force ◽  
Point Of Care ◽  
Pearson Correlation ◽  
World Health ◽  
P Value ◽  
Point Of Care Testing ◽  
The Mean

Troponin I is a cardiac biomarker recomended by The Third Global Myocardial Infarction Task Force World Health Organisation(WHO). Troponin plays a central role as a relevant biomarker that require reliable samples, methods, device and efficiency of time.Selecting the device, methods and sample used in the assay may affect the results and turn arround time. The aim of this study is toknow troponin I result using Point of care Testing device with a flourescence immunoassay methods using whole blood and laboratorybasedanalysis device with Enzyme-Linked Fluorescent Assay (ELFA) methods using serum by evaluation. Cross sectional study was heldon 50 subjects in Wahidin Sudirohusodo hospital during the period between July-August 2015, those who suspected suffering acutecoronary syndome (ACS) and underwent troponin I test ordered by the physician and also had whole blood sample. The subjects arearound 51.96±12.80 year old and most of them are men (62%). The mean consentration of troponin I with laboratoric-based analysis is0.50±1.69 μg/L and with POCT is 0.51±1.77. The Pearson correlation test shows the correlation (r) is 0.99 with the p value is <0.001.Bland and Altman methods show the mean difference between two assays is 0.014μg/L (95% confidence interval, -0.015; 0.043) withthe limit of agreement -0.19 to 0.22. Based on this study, it can be concluded that troponin I assay using POCT device can be used tosupport ACS diagnosis precisely and rapidly. It is suggested to perform futher study with concern on the patient’s clinical condition aswell as the diagnosis, so it can evaluate the device performance to measure troponin I levels consistently with the clinical condition.

scholarly journals P216 Comparative Assessment C-reactive Protein Between a Point-of-Care Testing and Current Standard of Care (Immunonephelometric testing)

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S272-S273
Author(s):  
G Lorenzon ◽  
I Marsilio ◽  
D Maniero ◽  
A Rigo ◽  
B Barberio ◽  
...  
Keyword(s):  
Inflammatory Disease ◽  
Point Of Care ◽  
Standard Of Care ◽  
Turnaround Time ◽  
Blood Collection ◽  
Standard Laboratory ◽  
Point Of Care Testing ◽  
C Reactive Protein ◽  
Serum Samples ◽  
Reactive Protein

Abstract Background C-reactive protein (CRP) is widely used as a biomarker of inflammatory disease activity in hospitalized and non-hospitalized patients. In particular, CRP is commonly used in patients suspected to have an inflammatory bowel disease (IBD) or with a confirmed diagnosis of IBD diagnosis in order to drive the diagnostic approach, to monitor disease activity and to guide therapeutic adjustments. However, standard laboratory CRP testing (Immunonephelometric assays) present some drawbacks, including a turnaround time of 1–2 hours, and the need of specialized equipment, offices and laboratory personnel. Because of that, point-of care testing (POCT) was recently developed in order to provide results within 2 minutes from blood collection, enabling a rapid response to clinical condition. Aim To determine the degree of analytical correlation between a recently developed POCT (ProciseDx) using capillary whole blood and the comparative Immunonephelometric assay using serum samples. Methods From October to November 2020, consecutive patients hospitalized at Gastroenterology Unit, Padua University Hospital, aged &gt; 18 years and with clinical evidence of active inflammatory disease or infection, who underwent to a standard of care CRP test (Dimension Vista – Siemens Healthineers) were included in the study (range 2.9–340 g/L). Within 1 hour from blood collection, in each patient, CRP quantitation from capillary whole blood collected by finger stick was performed using the ProciseDx CRP assay, with reportable range between 3.6–100 g/L. A Deming regression test was used to identify the correlation between the two methods. Results Eighty-three patients were enrolled (62.5% males with mean age ± SD: 60±18). The most common indications for hospitalisation were liver disease (34.9%), pancreatic disturbance (27.7%) and suspicious or recurrence of IBD (16.7%). ProciseDx POCT with finger prick samples required a turnaround time of 2±0.2 minutes, whereas serum samples analyzed in clinical laboratory with the reference method required a turnaround time of about 180±15 minutes (p&lt;0.001). Overall, the correlation between the two tests was high (R squared of 0.899 (95% CI 0.916–0.968)). In particular, the correlation between the methods was even higher with CRP values between 0–100 g/L with R squared of 0.961 (95% CI 0.958–0.986). Conclusion The ProciseDx POCT allows a more rapid and comparable accuracy of CRP assessment in hospitalized patients as compared to the standard laboratory measurement. Moreover, the ProciseDx POCT does not require specialised personnel to be performed. The use of ProciseDx POCT may improve and accelerate the decision-making approach, further reducing the resources required for CRP assessment.

Sign in / Sign up

Export Citation Format

Share Document