Performance Evaluation and Multicenter Consistency Study of Smartphone-based Hipee S2 Point-of-care Testing Urine Dipstick Analyser: Evaluation Study (Preprint)

2021 ◽  
Author(s):  
Qiang Zhang ◽  
Guoqing Wang ◽  
Xiaolong Zong ◽  
Jinghua Sun
Keyword(s):  
Health Management ◽  
Clinical Performance ◽  
Point Of Care ◽  
Method Comparison ◽  
Evaluation Study ◽  
Analytical Performance ◽  
Point Of Care Testing ◽  
Urine Dipstick ◽  
Quantitative Results ◽  
Carry Over

BACKGROUND With advances in mobile technology, smartphone-based point-of-care testing (POCT) urinalysis hold great potential for disease screening and health management for clinicians and individual users. The POCT devices need to have good analytical and clinical performance, but data are lacking. OBJECTIVE The purpose of this study is to evaluate the analytical performance of smartphone-based Hipee S2 POCT urine dipstick analyser. METHODS A total of 1,603 urine samples from three hospitals were collected. Precision, drift, carry-over, interference, and method comparison of Hipee S2 were evaluated. RESULTS The precision for each parameter, assessed by control materials, was acceptable. No sample carry-over or drift was observed. Ascorbate solution with 1 g/L had an inhibitory effect for the haemoglobin test. Agreement for specific gravity (SG) varied between moderate to substantial, for pondus hydrogenii (pH) was moderate, and for other parameters varied between substantial to excellent, on comparing the results obtained by Hipee S2 with those measured by laboratory reference analysers. The semi-quantitative results of microalbumin and creatinine were highly correlated with the quantitative results. CONCLUSIONS Hipee S2 POCT urine analyser showed acceptable analytical performance as a semi-quantitative method. It serves as a convenient alternate device for clinicians and individual users for urinalysis and health management.

Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT instrument in a true clinical setting

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Anders Abildgaard ◽  
Cindy Søndersø Knudsen ◽  
Lise Nørkjær Bjerg ◽  
Sten Lund ◽  
Julie Støy
Keyword(s):  
Clinical Setting ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Method Comparison ◽  
Glycated Haemoglobin ◽  
Analytical Performance ◽  
Point Of Care Testing ◽  
Performance Specifications ◽  
Ion Exchange Hplc ◽  
Analytical Imprecision

Abstract Objectives The glycated haemoglobin fraction A1c (HbA1c) is widely used in the management of diabetes mellitus, and the Siemens DCA Vantage™ point-of-care testing (POCT) instrument offers rapid HbA1c results even far from a clinical laboratory. However, the analytical performance has been questioned, and not much is known about effects of changing reagent lot, instrument and operator. We therefore compared the analytical performance of the DCA Vantage™ with established routine methods (Tosoh G8/G11 ion exchange HPLC) in a true clinical setting at two Danish hospitals. Methods We extracted all routine clinical HbA1c results incidentally drawn from the same patient within 48 h (n=960 pairs) and evaluated the effect of reagent lot, operator and instrument. We also performed a prospective method comparison in our diabetes out-patient clinic (n=97). Results The critical difference (CD) between two POCT results varied between 5.14 and 6.61 mmol/mol (0.47–0.55%), and the analytical imprecision of the DCA Vantage™ (CVA) was >3%. Significant effect of reagent lot and inter-instrument differences were found, whereas no effect of operator was seen. Conclusions The DCA Vantage™ HbA1c analysis does not fulfil the prevailing analytical performance specifications, but rigorous validation of new reagent lots and continuous recalibration of instruments may potentially improve the precision substantially. Our findings, therefore, clearly emphasise the necessity of a close collaboration between clinicians and laboratory professionals in the POCT field. Finally, POCT HbA1c results should always be interpreted together with other measures of glycaemic control to avoid inappropriate change of patient treatments due to measurement uncertainty.

scholarly journals Method comparison of beta‐hydroxybutyrate point‐of‐care testing to serum in healthy children

JIMD Reports ◽  
2021 ◽  
Author(s):  
Komalben Parmar ◽  
Maua Mosha ◽  
David A. Weinstein ◽  
Rebecca Riba‐Wolman
Keyword(s):  
Point Of Care ◽  
Method Comparison ◽  
Healthy Children ◽  
Point Of Care Testing ◽  
Beta Hydroxybutyrate

scholarly journals Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR

2021 ◽  
Author(s):  
Isabell Wagenhaeuser ◽  
Kerstin Knies ◽  
Vera Rauschenberger ◽  
Michael Eisenmann ◽  
Miriam McDonogh ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
Viral Load ◽  
Clinical Performance ◽  
Point Of Care ◽  
Hospital Setting ◽  
High Viral Load ◽  
Evaluation Study ◽  
Study Cohort ◽  
Protein Variant ◽  
Atypical Symptoms

Background Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data is sparse. Methods In a prospective performance evaluation study, RDT from three manufacturers (NADAL, Panbio, MEDsan) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardized RT-qPCR Cycle threshold (Ct) values. The data collection period ranged from November 12, 2020 to February 28, 2021. Findings Overall, sensitivity of RDT compared to RT-qPCR was 42.57% (95% CI 33.38%-52.31%), and specificity 99.68% (95% CI 99.48%-99.80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of 10^8 SARS-CoV-2 RNA copies per ml to 8.82% in samples with a viral load lower than 104 SARS-CoV-2 RNA copies per ml. No significant differences in sensitivity or specificity could be observed between the three manufacturers, or between samples with and without spike protein variant B.1.1.7. The NPV in the study cohort was 98.84%; the PPV in persons with typical COVID-19 symptoms was 97.37%, and 28.57% in persons without or with atypical symptoms. Interpretation RDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available. Funding German Federal Ministry for Education and Science (BMBF), Free State of Bavaria

scholarly journals Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice

BMJ Open ◽  
2015 ◽  
Vol 5 (5) ◽  
pp. e006857-e006857 ◽  
Author(s):  
M. J. C. Schot ◽  
S. van Delft ◽  
A. M. J. Kooijman-Buiting ◽  
N. J. de Wit ◽  
R. M. Hopstaken
Keyword(s):  
General Practice ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Point Of Care ◽  
Analytical Performance ◽  
Point Of Care Testing ◽  
User Friendliness

scholarly journals Glucose and Glycated Haemoglobin Point-of-care Testing and Early Diagnosis of Diabetes and Pre-diabetes

2010 ◽  
Vol 06 ◽  
pp. 24 ◽  
Author(s):  
Roger K Schindhelm ◽  
Erna Lenters-Westra ◽  
Marion J Fokkert ◽  
Robbert J Slingerland ◽  
◽  
...  
Keyword(s):  
Point Of Care ◽  
Glycated Haemoglobin ◽  
Analytical Performance ◽  
Performance Criteria ◽  
Point Of Care Testing ◽  
Early Screening ◽  
Cardiovascular Morbidity And Mortality ◽  
Elevated Glucose ◽  
Early Diagnosis Of Diabetes ◽  
Number Of Individuals

The number of individuals with impaired glucose metabolism (‘pre-diabetes’) and type 2 diabetes is reaching epidemic proportions. This increase is associated with higher cardiovascular morbidity and mortality. Early screening for diabetes and pre-diabetes (i.e. elevated glucose and/or glycated haemoglobin [HbA1c]) may aid in the reduction of diabetes-related complications. Point-of-care testing, defined as testing at or near the site of the patient, is able to bring diagnostic tests and its associated therapeutic actions immediately to the patient and may aid in the detection of diabetes and the reduction of complications. However, the majority of available point-of-care testing devices for glucose and HbA1cdo not meet generally accepted analytical performance criteria and may underestimate the true risk of diabetes. Until these analytical performance issues have been addressed properly, caution should be exercised in the use of point-of-care testing of glucose and HbA1c in the diagnosis of and screening for pre-diabetes and diabetes.

scholarly journals Analytical validation of a highly sensitive point-of-care system for cardiac troponin I determination

2019 ◽  
Vol 58 (1) ◽  
pp. 138-145 ◽  
Author(s):  
Federica Braga ◽  
Elena Aloisio ◽  
Andrea Panzeri ◽  
Takahito Nakagawa ◽  
Mauro Panteghini
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Point Of Care ◽  
Total Error ◽  
Method Comparison ◽  
Reference Limit ◽  
Highly Sensitive ◽  
Limit Of Quantitation

Abstract Background Highly sensitive cardiac troponin assays (hs-cTn) are not available as point-of-care (POC) measurements. As rapid testing cannot be achieved at the expense of clinical performance, there is an urgent need to develop and rigorously validate POC hs-cTn. Konica Minolta (KM) has recently developed a surface plasmon-field enhanced fluorescence spectroscopy-based POC hs-cTn I system. Methods We validated the analytical characteristics of the KM POC system according to the international guidelines. Results Limit of blank (LoB) and limit of detection (LoD) were 0.35 and 0.62 ng/L, respectively, hs-cTn I concentrations corresponding to a total CV of 20%, 10% and 5% were 1.5, 3.9 and 11.0 ng/L, respectively. Method comparison studies showed that KM calibration was successfully traced to higher-order references. Limit of quantitation (LoQ), i.e. the hs-cTn I concentration having a total error of measurement of ≤34%, was 10.0 ng/L. The upper reference limit (URL) for 600 healthy blood donors was calculated at 12.2 ng/L (90% confidence interval [CI]: 9.2–39.2), while sex-partitioned URLs were 20.6 (males) and 10.7 ng/L (females), respectively (p < 0.0001). KM assay measured hs-cTn I concentrations >LoD in 65.7% of all reference individuals, in 76.7% of males and in 54.7% of females, respectively. Conclusions The KM system joins the characteristics of POC systems to the analytical performance of hs-cTn.

scholarly journals Analytical performance and method comparison of a quantitative point-of-care immunoassay for measurement of bile acids in cats and dogs

2020 ◽  
Vol 33 (1) ◽  
pp. 35-46
Author(s):  
Kristina Weiler ◽  
Katharina Kleber ◽  
Sabine Zielinsky ◽  
Andreas Moritz ◽  
Natali Bauer
Keyword(s):  
Bile Acids ◽  
Point Of Care ◽  
Method Comparison ◽  
Reference Method ◽  
Analytical Performance ◽  
Total Serum ◽  
Limit Of Quantification ◽  
Coefficients Of Variation ◽  
Test Kit ◽  
Allowable Error

Point-of-care analyzers (POCAs) for quantitative assessment of bile acids (BAs) are scarce in veterinary medicine. We evaluated the Fuji Dri-Chem Immuno AU10V analyzer and v-BA test kit (Fujifilm) for detection of feline and canine total serum BA concentration. Results were compared with a 5th-generation assay as reference method and a 3rd-generation assay, both run on a bench-top analyzer. Analytical performance was assessed at 3 different concentration ranges, and with interferences. For method comparison, samples of 60 healthy and diseased cats and 64 dogs were included. Linearity was demonstrated for a BA concentration up to 130 µmol/L in cats ( r = 0.99) and 110 µmol/L in dogs ( r = 0.99). The analyzer showed high precision near the lower limit of quantification of 2 µmol/L reported by the manufacturer. Intra- and inter-assay coefficients of variation were < 5% for both species and all concentrations. Interferences were observed for bilirubin (800 mg/L) and lipid (4 g/L). There was excellent correlation with the reference method for feline ( rs = 0.98) and canine samples ( rs = 0.97), with proportional biases of 6.7% and −1.3%, respectively. However, a large bias (44.1%) was noted when the POCA was compared to the 3rd-generation assay. Total observed error was less than total allowable error at the 3 concentrations. The POCA reliably detected feline and canine BA in clinically relevant concentrations.

Analytical and clinical performance evaluation of two POC tests for therapeutic drug monitoring of infliximab

2019 ◽  
Vol 57 (6) ◽  
pp. 856-863 ◽  
Author(s):  
Dorien Van den Bossche ◽  
Dieter De Smet ◽  
Johan Debrabandere ◽  
Hilde Vanpoucke
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Clinical Performance ◽  
Method Comparison ◽  
Serial Dilution ◽  
Analytical Performance ◽  
Enzyme Linked Immunosorbent Assay ◽  
Therapeutic Drug ◽  
Systematic Bias ◽  
Wide Range

Abstract Background Infliximab (IFX) is an effective therapy in patients with inflammatory bowel disease. Serum IFX trough concentrations correlate well with clinical, biological and endoscopic outcomes. Therefore, therapeutic drug monitoring (TDM) of infliximab is useful for dose optimization and prevention of secondary treatment failure. In the present study, analytical and clinical performance of two point-of-care (POC) tests, RIDA®QUICK IFX Monitoring assay (R-biopharm) and Quantum Blue® Infliximab assay (Bühlmann), have been evaluated and compared to our established enzyme-linked immunosorbent assay (ELISA) (apDia IFX ELISA). Methods Analytical performance was assessed according to the CLSI EP5-A2 protocol using the manufacturer’s kit controls and different serial dilution series. Method comparison with our established ELISA was done using a wide range of consecutive patient samples (n=180). Clinical concordance was evaluated by categorization based on well-known therapeutic cut-off points (3–7 μg/mL). Results The analytical performance of both POC tests was inferior to the established ELISA, but acceptable based on the manufacturer’s quality claims. Eight-point serial dilution confirmed the analytical performance data in the low-level measuring range. Eleven-point serial dilution demonstrated linearity for both POC tests over the studied concentration range. Method comparison with the ELISA showed significant negative proportional bias for the RIDA®QUICK IFX Monitoring assay. However, good correlation and clinical concordance were shown. Quantum Blue® Infliximab assay showed a significant positive proportional and a negative systematic bias in comparison with the ELISA, resulting in overestimation of IFX levels with impact on clinical concordance data. Conclusions Both POC tests have their own specific benefits and drawbacks but are suitable for therapeutic drug monitoring of IFX. However, long-term monitoring of IFX trough levels requires measurement of IFX concentrations with the same assay.

scholarly journals A novel RT-LAMP workflow for rapid salivary diagnostics of COVID-19 and effects of age, gender and time from symptom onset

2021 ◽  
Author(s):  
Gerson Shigeru Kobayashi ◽  
Luciano Abreu Brito ◽  
Danielle De Paula Moreira ◽  
Angela May Suzuki ◽  
Gabriella Shih Ping Hsia ◽  
...  
Keyword(s):  
Viral Load ◽  
Symptom Onset ◽  
Clinical Performance ◽  
Point Of Care ◽  
Rapid Diagnostics ◽  
Rt Pcr ◽  
Point Of Care Testing ◽  
Viral Loads ◽  
Peak Viral Load ◽  
Salivary Diagnostics

Objectives: Rapid diagnostics is pivotal to curb SARS-CoV-2 transmission, and saliva has emerged as a practical alternative to naso/oropharyngeal (NOP) specimens. We aimed to develop a direct RT-LAMP workflow for viral detection in saliva, and to provide more information regarding its potential in COVID-19 diagnostics. Methods: Clinical and contrived specimens were used to screen/optimize formulations and sample processing protocols. Salivary viral load was determined in symptomatic patients to evaluate clinical performance (n = 90) and to characterize saliva based on age, gender and time from onset of symptoms (n = 49). Results: The devised workflow achieved 93.2% sensitivity, 97% specificity, and 0.895 Kappa for salivas containing >102 copies/μL. Further analyses in saliva showed peak viral load in the first days of symptoms and lower viral loads in females, particularly among young individuals (<38 years). NOP RT-PCR data did not yield relevant associations. Conclusions: This novel saliva RT-LAMP workflow can be applied to point-of-care testing. This work reinforces that saliva better correlates with transmission dynamics than NOP specimens, and reveals gender differences that may reflect higher transmission by males. To maximize detection, testing should be done immediately after symptom onset, especially in females.

Sign in / Sign up

Export Citation Format

Share Document