Validation of a point of care lipid analyser using a hospital based reference laboratory

2006 ◽  
Vol 175 (4) ◽  
pp. 30-35 ◽  
Author(s):  
M. Carey ◽  
C. Markham ◽  
P. Gaffney ◽  
G. Boran ◽  
V. Maher
Keyword(s):  
Point Of Care ◽  
Reference Laboratory

scholarly journals Validation of Point-of-Care Glucose Testing for Diagnosis of Type 2 Diabetes

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Marijana Vučić Lovrenčić ◽  
Vanja Radišić Biljak ◽  
Sandra Božičević ◽  
Edita Pape-Medvidović ◽  
Spomenka Ljubić
Keyword(s):  
Glucose Tolerance ◽  
Point Of Care ◽  
Previous History ◽  
Blood Sampling ◽  
Oral Glucose ◽  
Reference Laboratory ◽  
Diabetes Diagnosis ◽  
Sample Type ◽  
Glucose Testing ◽  
Glucose Meter

Point-of-care (POC) glucose technology is currently considered to be insufficiently accurate for the diagnosis of diabetes. The objective of this study was to investigate the diagnostic accuracy of an innovative, interference-resistant POC glucose meter (StatStrip glucose hospital meter, Nova Biomedical, USA) in subjects with a previous history of dysglycaemia, undergoing a 75 g diagnostic oral glucose tolerance test (oGTT). Venous and capillary blood sampling for the reference laboratory procedure (RLP) and POC-glucose measurement was carried out at fasting and 2 h oGTT, and categories of glucose tolerance were classified according to 2006 WHO diagnostic criteria for the respective sample type. We found an excellent between-method correlation at fasting (r=0.9681,P<0.0001) and 2 h oGTT (r=0.9768,P<0.0001) and an almost perfect diagnostic agreement (weighted Kappa = 0.858). Within a total of 237 study subjects, 137 were diagnosed with diabetes with RLP, and only 6 of them were reclassified as having glucose intolerance with POC. The diagnostic performance of POC-fasting glucose in discriminating between the normal and any category of disturbed glucose tolerance did not differ from the RLP (P=0.081). Results of this study indicate that StatStrip POC glucose meter could serve as a reliable tool for the diabetes diagnosis, particularly in primary healthcare facilities with dispersed blood sampling services.

scholarly journals Accuracy of Rapid Point-of-Care Antibody Test in patients with suspected or confirmed COVID-19

2020 ◽  
Author(s):  
Rama Vancheeswaran ◽  
Merlin L Willcox ◽  
Beth Stuart ◽  
Matthew Knight ◽  
Hala Kandil ◽  
...  
Keyword(s):  
Point Of Care ◽  
Antibody Test ◽  
Reference Laboratory ◽  
List Type ◽  
Reference Standard ◽  
Point Of Care Test ◽  
History Of ◽  
Antibody Tests ◽  
Composite Reference Standard ◽  
Rapid Antibody

AbstractObjectivesTo assess the real-world diagnostic accuracy of the Livzon point-of-care rapid test for antibodies to SARS-COV-2DesignProspective cohort studySettingDistrict general hospital in EnglandParticipants173 Patients and 224 hospital staff with a history of COVID-19 symptoms, and who underwent PCR and/or reference antibody testing for COVID-19.InterventionsThe Livzon point-of-care (POC) lateral flow immunoassay rapid antibody test (IgM and IgG) was conducted at least 7 days after onset of symptoms and compared to the composite reference standard of PCR for SARS-COV-2 plus reference laboratory testing for antibodies to SARS-COV-2. The SARS-CoV-2 RT-PCR was tested using the available molecular technology during the study time (PHE laboratories, GeneXpert® system Xpert, Xpress SARS-CoV-2 and Source bioscience laboratory). All molecular platforms/assays were PHE/NHSE approved. The reference antibody test was the Elecsys Anti-SARS-CoV-2 assay (Roche diagnostics GmBH).Main outcome measuresSensitivity and specificity of the rapid antibody testResultsThe reference antibody test was positive in 190/268 (70.9%) of participants with a history of symptoms suggestive of COVID-19; in the majority (n=312) the POC test was taken 35 days or more after onset of symptoms. The POC antibody test had an overall sensitivity of 90.1% (292/328, 95% CI 86.3 – 93.1) and specificity of 100% (68/68, 95% CI 94.7 - 100) for confirming prior SARS-CoV-2 infection when compared to the composite reference standard. Sensitivity was 97.8% (89/92, 95% CI 92.3% to 99.7%) in participants who had been admitted to hospital and 84.4% (124/147, 95% CI 77.5% to 89.8%) in those with milder illness who had never been seen in hospital.ConclusionsThe Livzon point-of-care antibody test had comparable sensitivity and specificity to the reference laboratory antibody test, so could be used in clinical settings to support decision-making about patients presenting with more than 10 days of symptoms of COVID-19.What is already known on this topic-Presence of IgG and IgM antibodies to SARS-COV-2 indicates that the person was infected at least 7 days previously and is usually no longer infectious.-Rapid point-of-care tests for antibodies to SARS-COV-2 are widely available, cheap and easy to use-Preliminary evaluations suggested that rapid antibody tests may have insufficient accuracy to be useful for testing individual patients.What this study adds-The rapid point-of-care test for antibodies to SARS-COV-2 was 90.1% sensitive and 100% specific compared to reference standards for prior infection with COVID-19.-This is comparable to reference antibody tests-The point-of-care test evaluated in this study could be used to support clinical decision-making in real time, for patients presenting with symptoms of possible COVID-19 with at least 10 days of symptoms.

scholarly journals The QuantuMDx Q-POC SARS-CoV-2 RT-PCR assay for rapid detection of COVID-19 at point-of-care: preliminary evaluation of a novel technology

2021 ◽  
Author(s):  
Jessica Caffry ◽  
Matthew Selby ◽  
Katie Barr ◽  
George Morgan ◽  
David McGurk ◽  
...  
Keyword(s):  
Point Of Care ◽  
Reference Laboratory ◽  
Preliminary Evaluation ◽  
Rt Pcr ◽  
Reference Test ◽  
Pcr Assay ◽  
Current Standard ◽  
Primary Analysis ◽  
Point Of Care Test ◽  
Control And Management

Background: Accurate, affordable, and rapid point-of-care (PoC) diagnostics are critical to the global control and management of the COVID-19 pandemic. The current standard for accurate diagnosis of SARS-CoV-2 is laboratory-based reverse transcription polymerase chain reaction (RT-PCR). Here, we report a preliminary prospective performance evaluation of the QuantuMDx Q-POC SARS CoV-2 RT-PCR assay. Methods: Between November 2020 and March 2021, we obtained 49 longitudinal nose and throat swabs from 29 individuals hospitalised with RT-PCR confirmed COVID-19 at St Georges' NHS Foundation Trust, London (UK). In addition, we obtained 101 mid nasal swabs from healthy volunteers in June 2021. We then used these samples to evaluate the Q-POC SARS-CoV-2 RT-PCR assay. The primary analysis was to compare the sensitivity and specificity of the Q-POC test against a reference laboratory-based RT-PCR assay. Results: The overall sensitivity of the Q-POC test compared with the reference test was 96.88% (83.78%- 99.92% CI) for a cycle threshold (Ct) cut-off value for the reference test of 35 and 80.00% (64.35% to 90.95% CI) without altering the reference test's Ct cut-off value of 40. Conclusions: The Q-POC test is a sensitive, specific and rapid point-of-care test for SARS-CoV-2 at a reference Ct cut-off value of 35. The Q-POC test provides an accurate and afforda-ble option for RT-PCR at point-of-care without the need for sample pre-processing and laboratory handling. The Q-POC test would enable rapid diagnosis and clinical triage in acute care and other settings.

scholarly journals Same-day diagnostic and surveillance data for tuberculosis via whole genome sequencing of direct respiratory samples

2016 ◽  
Author(s):  
Antonina A. Votintseva ◽  
Phelim Bradley ◽  
Louise Pankhurst ◽  
Carlos del Ojo Elias ◽  
Matthew Loose ◽  
...  
Keyword(s):  
Whole Genome Sequencing ◽  
Genome Sequencing ◽  
Antibiotic Susceptibility ◽  
Point Of Care ◽  
Low Cost ◽  
Illumina Miseq ◽  
Turnaround Time ◽  
Reference Laboratory ◽  
Whole Genome ◽  
Specific Pcr

AbstractRoutine full characterization of Mycobacterium tuberculosis (TB) is culture-based, taking many weeks. Whole-genome sequencing (WGS) can generate antibiotic susceptibility profiles to inform treatment, augmented with strain information for global surveillance; such data could be transformative if provided at or near point of care.We demonstrate a low-cost DNA extraction method for TB WGS direct from patient samples. We initially evaluated the method using the Illumina MiSeq sequencer (40 smear-positive respiratory samples, obtained after routine clinical testing, and 27 matched liquid cultures). M. tuberculosis was identified in all 39 samples from which DNA was successfully extracted. Sufficient data for antibiotic susceptibility prediction was obtained from 24 (62%) samples; all results were concordant with reference laboratory phenotypes. Phylogenetic placement was concordant between direct and cultured samples. Using an Illumina MiSeq/MiniSeq the workflow from patient sample to results can be completed in 44/16 hours at a cost of £96/£198 per sample.We then employed a non-specific PCR-based library preparation method for sequencing on an Oxford Nanopore Technologies MinION sequencer. We applied this to cultured Mycobacterium bovis BCG strain (BCG), and to combined culture-negative sputum DNA and BCG DNA. For the latest flowcell, the estimated turnaround time from patient to identification of BCG was 6 hours, with full susceptibility and surveillance results 2 hours later. Antibiotic susceptibility predictions were fully concordant. A critical advantage of the MinION is the ability to continue sequencing until sufficient coverage is obtained, providing a potential solution to the problem of variable amounts of M. tuberculosis in direct samples.

scholarly journals Same-Day Diagnostic and Surveillance Data for Tuberculosis via Whole-Genome Sequencing of Direct Respiratory Samples

2017 ◽  
Vol 55 (5) ◽  
pp. 1285-1298 ◽  
Author(s):  
Antonina A. Votintseva ◽  
Phelim Bradley ◽  
Louise Pankhurst ◽  
Carlos del Ojo Elias ◽  
Matthew Loose ◽  
...  
Keyword(s):  
Whole Genome Sequencing ◽  
Genome Sequencing ◽  
Antibiotic Susceptibility ◽  
Point Of Care ◽  
Low Cost ◽  
Illumina Miseq ◽  
Reference Laboratory ◽  
Whole Genome ◽  
Content Type ◽  
Phylogenetic Placement

ABSTRACT Routine full characterization of Mycobacterium tuberculosis is culture based, taking many weeks. Whole-genome sequencing (WGS) can generate antibiotic susceptibility profiles to inform treatment, augmented with strain information for global surveillance; such data could be transformative if provided at or near the point of care. We demonstrate a low-cost method of DNA extraction directly from patient samples for M. tuberculosis WGS. We initially evaluated the method by using the Illumina MiSeq sequencer (40 smear-positive respiratory samples obtained after routine clinical testing and 27 matched liquid cultures). M. tuberculosis was identified in all 39 samples from which DNA was successfully extracted. Sufficient data for antibiotic susceptibility prediction were obtained from 24 (62%) samples; all results were concordant with reference laboratory phenotypes. Phylogenetic placement was concordant between direct and cultured samples. With Illumina MiSeq/MiniSeq, the workflow from patient sample to results can be completed in 44/16 h at a reagent cost of £96/£198 per sample. We then employed a nonspecific PCR-based library preparation method for sequencing on an Oxford Nanopore Technologies MinION sequencer. We applied this to cultured Mycobacterium bovis strain BCG DNA and to combined culture-negative sputum DNA and BCG DNA. For flow cell version R9.4, the estimated turnaround time from patient to identification of BCG, detection of pyrazinamide resistance, and phylogenetic placement was 7.5 h, with full susceptibility results 5 h later. Antibiotic susceptibility predictions were fully concordant. A critical advantage of MinION is the ability to continue sequencing until sufficient coverage is obtained, providing a potential solution to the problem of variable amounts of M. tuberculosis DNA in direct samples.

Anticoagulation Monitoring Part 1: Warfarin and Parenteral Direct Thrombin Inhibitors

2005 ◽  
Vol 39 (6) ◽  
pp. 1049-1055 ◽  
Author(s):  
Sarah A Spinler ◽  
Edith A Nutescu ◽  
Maureen A Smythe ◽  
Ann K Wittkowsky
Keyword(s):  
Clinical Application ◽  
Web Sites ◽  
English Language ◽  
Point Of Care ◽  
Anticoagulation Therapy ◽  
Thrombin Inhibitors ◽  
Care Utilization ◽  
Direct Thrombin Inhibitors ◽  
Reference Laboratory ◽  
Medline Search

OBJECTIVE: To review the availability, mechanisms, limitations, and clinical application of point-of-care (POC) devices used in the management of warfarin and parenteral direct thrombin inhibitors. DATA SOURCES: Scientific articles were identified through a MEDLINE search (1966–August 2004), manufacturer Web sites, additional references listed in articles and Web sites, and abstracts from scientific meetings. STUDY SELECTION AND DATA EXTRACTION: English-language literature from clinical trials was reviewed to evaluate the accuracy, reliability, and clinical application of POC monitoring devices. DATA SYNTHESIS: The prothrombin time expressed as the international normalized ratio (PT—INR) is a well-established test for monitoring warfarin anticoagulation. Multiple devices are available for POC testing. Because there is no universally accepted standard, the performance of each device is typically tested against a standard test performed in a reference laboratory. Performance of currently available devices, as measured by correlations to a standard reference laboratory PT—INR, may be considered very good and acceptable for use in patient care. Utilization of patient self-testing and patient self-monitoring of warfarin anticoagulation using POC devices is increasing. Parenteral direct thrombin inhibitors are typically monitored using a standard laboratory activated partial thromboplastin time. Some research has shown that POC monitoring of direct thrombin inhibitors using the ecarin clotting time is helpful for patients undergoing cardiopulmonary bypass surgery, although that test is not readily available. CONCLUSIONS: POC testing for anticoagulation therapy has been available for >20 years. Multiple POC devices are available to monitor warfarin. There is some variability in results between devices and between reagents used in the same device. Despite these limitations, POC monitoring of warfarin via the PT—INR is an integral part of clinical practice. Additional research evaluating POC monitoring of direct thrombin inhibitors is necessary.

scholarly journals Point-of-care creatinine testing for kidney function measurement prior to contrast-enhanced diagnostic imaging: evaluation of the performance of three systems for clinical utility

2018 ◽  
Vol 56 (8) ◽  
pp. 1269-1276 ◽  
Author(s):  
Beverly Snaith ◽  
Martine A. Harris ◽  
Bethany Shinkins ◽  
Marieke Jordaan ◽  
Michael Messenger ◽  
...  
Keyword(s):  
Kidney Function ◽  
Clinical Utility ◽  
Point Of Care ◽  
Reference Laboratory ◽  
Function Measurement ◽  
Limits Of Agreement ◽  
Imaging Evaluation ◽  
Average Bias ◽  
Iodinated Contrast ◽  
Imaging Department

AbstractBackground:Acute kidney injury (AKI) can occur rarely in patients exposed to iodinated contrast and result in contrast-induced AKI (CI-AKI). A key risk factor is the presence of preexisting chronic kidney disease (CKD); therefore, it is important to assess patient risk and obtain kidney function measurement prior to administration. Point-of-care (PoC) testing provides an alternative strategy but there remains uncertainty, with respect to diagnostic accuracy and clinical utility.Methods:A device study compared three PoC analysers (Nova StatSensor, Abbott i-STAT and Radiometer ABL800 FLEX) with a reference laboratory standard (Roche Cobas 8000 series, enzymatic creatinine). Three hundred adult patients attending a UK hospital phlebotomy department were recruited to have additional blood samples for analysis on the PoC devices.Results:The ABL800 FLEX had the strongest concordance with laboratory measured serum creatinine (mean bias=−0.86, 95% limits of agreement=−9.6 to 7.9) followed by the i-STAT (average bias=3.88, 95% limits of agreement=−8.8 to 16.6) and StatSensor (average bias=3.56, 95% limits of agreement=−27.7 to 34.8). In risk classification, the ABL800 FLEX and i-STAT identified all patients with an eGFR≤30, whereas the StatSensor resulted in a small number of missed high-risk cases (n=4/13) and also operated outside of the established performance goals.Conclusions:The screening of patients at risk of CI-AKI may be feasible with PoC technology. However, in this study, it was identified that the analyser concordance with the laboratory reference varies. It is proposed that further research exploring PoC implementation in imaging department pathways is needed.

scholarly journals Accuracy and Precision of a Point-of-Care HbA1c Test

2019 ◽  
Vol 14 (5) ◽  
pp. 883-889
Author(s):  
William D. Arnold ◽  
Kenneth Kupfer ◽  
Randie R. Little ◽  
Meera Amar ◽  
Barry Horowitz ◽  
...  
Keyword(s):  
Whole Blood ◽  
Point Of Care ◽  
Venous Blood ◽  
Reference Laboratory ◽  
Test Results ◽  
Blood Samples ◽  
Accuracy And Precision ◽  
The Mean ◽  
Whole Blood Samples ◽  
Highly Correlated

Background: Point-of-care (POC) hemoglobin A1c (HbA1c) testing has advantages over laboratory testing, but some questions have remained regarding the accuracy and precision of these methods. The accuracy and the precision of the POC Afinion™ HbA1c Dx test were investigated. Methods: Samples spanning the assay range were collected from prospectively enrolled subjects at three clinical sites. The accuracy of the POC test using fingerstick and venous whole blood samples was estimated via correlation and bias with respect to values obtained by an NGSP secondary reference laboratory (SRL). The precision of the POC test using fingerstick samples was estimated from duplicate results by calculating the coefficient of variation (CV) and standard deviation (SD), and separated into its components using analysis of variance (ANOVA). The precision of the POC test using venous blood was evaluated from samples run in four replicates on each of three test cartridge lots, twice per day for 10 consecutive days. The SD and CV by study site and overall were calculated. Results: Across the assay range, POC test results from fingerstick and venous whole blood samples were highly correlated with results from the NGSP SRL ( r = .99). The mean bias was −0.021% HbA1c (−0.346% relative) using fingerstick samples and −0.005% HbA1c (−0.093% relative) using venous samples. Imprecision ranged from 0.62% to 1.93% CV for fingerstick samples and 1.11% to 1.69% CV for venous samples. Conclusions: The results indicate that the POC test evaluated here is accurate and precise using both fingerstick and venous whole blood.

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