Diagnostic Properties of a Portable Point-of-Care Method to Measure Bilirubin and a Transcutaneous Bilirubinometer

Neonatology ◽  
2021 ◽  
Vol 118 (6) ◽  
pp. 678-684
Author(s):  
Mahendra Tri Arif Sampurna ◽  
Siti Annisa Dewi Rani ◽  
Pieter J. J. Sauer ◽  
Arend F. Bos ◽  
Peter H. Dijk ◽  
...  
Keyword(s):  
Point Of Care ◽  
False Negative ◽  
Transcutaneous Bilirubin ◽  
Measuring Devices ◽  
Treatment Thresholds ◽  
Mean Differences ◽  
Sensitivity Specificity ◽  
A Prospective Study ◽  
Transcutaneous Bilirubinometer ◽  
Diagnostic Properties

<b><i>Background:</i></b> Recently, the Bilistick®, a point-of-care instrument to measure bilirubin levels, has been developed. It is fast and cheaper than transcutaneous bilirubin (TCB)-measuring devices, but data on diagnostic properties are scarce. <b><i>Objective:</i></b> This study aimed to compare the performance of the Bilistick® (BM-BS 1.0 – FW version 2.0.1) and the JM-105 bilirubinometer for measuring bilirubin. <b><i>Method:</i></b> This is a prospective study in infants born after ≥32 weeks’ gestation, and/or a birth weight of ≥1,500 g, and a postnatal age ≤14 days in Surabaya, Indonesia. Bilirubin was measured with the Bilistick® System (BM-BS 1.0 – FW version 2.0.1), transcutaneously (TCB) with the JM-105 bilirubinometer, and in serum (TSB) with a routine laboratory technique. Mean differences and 95% limits of agreement (LOA) and correlations were calculated. <b><i>Result:</i></b> We enrolled 149 neonates and 126 had paired measurements of Bilistick® bilirubin, TCB, and TSB. Bilistick® failed in 16 (10.7%) infants. Mean Bilistick® bilirubin-TSB difference was −11 µmol/L (95% LOA: −101 to 79 µmol/L) and <i>r</i> = 0.738 (<i>p</i> &#x3c; 0.001). Mean TCB-TSB difference was 26 μmol/L (95% LOA: −33 to 88) and <i>r</i> = 0.785 (<i>p</i> &#x3c; 0.001). The sensitivity, specificity, PPV, and NPV for Bilistick® bilirubin for a TSB above treatment thresholds were 0.74, 0.84, 0.67, and 0.88, respectively, and for TCB 0.92, 0.64, 0.54, and 0.95, respectively. <b><i>Conclusion:</i></b> The Bilistick® System (BM-BS 1.0 – FW version 2.0.1) underestimates TSB, whereas TCB overestimates TSB in jaundiced Indonesian infants. Further improvement of Bilistick®’s diagnostic accuracy with less false-negative readings is essential to increase its use.

scholarly journals Evaluation of saliva molecular point of care for detection of SARS-CoV-2 in ambulatory care

2021 ◽  
Author(s):  
Jerome Le Goff ◽  
Solen Kerneis ◽  
Caroline Elie ◽  
Severine Mercier Delarue ◽  
Nabil Gastli ◽  
...  
Keyword(s):  
Point Of Care ◽  
False Negative ◽  
Lamp Assay ◽  
Rapid Identification ◽  
Ambulatory Setting ◽  
Nasopharyngeal Swab ◽  
Lower Sensitivity ◽  
Rt Pcr ◽  
A Prospective Study ◽  
Antigen Testing

Background: The rapid identification of SARS-CoV-2 infected individuals is a cornerstone in strategies for the control of virus spread. The sensitivity of SARS-CoV-2 RNA detection by RT-PCR is similar in saliva and nasopharyngeal swab. Rapid molecular point-of-care tests in saliva could facilitate, broaden and speed up the diagnosis. Objectives and methods: We conducted a prospective study in two community COVID-19 screening centers to evaluate the performances of a CE-marked RT-LAMP assay (EasyCoV) specifically designed for the detection of SARS-CoV-2 RNA from fresh saliva samples, compared to nasopharyngeal RT-PCR as reference test, saliva RT-PCR and nasopharyngeal antigen testing. Results: Overall, 117 of the 1718 participants (7%) were tested positive with nasopharyngeal RT-PCR. Sensitivities of saliva RT-PCR and nasopharyngeal antigen test were 93% (95% Confidence Interval (95%CI): 86-97) and 85% (95%CI: 77-91), respectively. The sensitivity and specificity of the RT-LAMP assay in saliva were 34% (95%CI: 26-44) and 97% (95%CI: 96-98). The performance was similar in symptomatic and asymptomatic participants and whatever the reference standard considered. Ct values of nasopharyngeal RT-PCR were significantly lower in the 40 true positive subjects with saliva RT-LAMP (Ct 25.9) than in the 48 false negative subjects with saliva RT-LAMP (Ct 28.4) (p=0.028). Conclusion: In the ambulatory setting, the detection of SARS-CoV-2 from crude saliva samples with the RT-LAMP assay had a lower sensitivity than nasopharyngeal RT-PCR, saliva RT-PCR and nasopharyngeal antigen testing.

Evaluation of the Cardiac reader® as a point-of-care instrument for measurement of fibrin D-dimers in dogs

2009 ◽  
Vol 37 (05) ◽  
pp. 319-325 ◽  
Author(s):  
A. Moritz ◽  
N. Bauer
Keyword(s):  
Point Of Care ◽  
Plasma Concentrations ◽  
False Negative ◽  
Reference Interval ◽  
Comparison Method ◽  
Likelihood Ratios ◽  
Negative Results ◽  
Blood Specimens ◽  
Sensitivity Specificity ◽  
D Dimer

Summary Objective: The aim of this study was the evaluationof the automated point-of-care analyzer Cardiac reader® for quantitative fibrin D-dimer measurement compared to the Liatest™ D-Di™ run on the bench top analyzer STA Compact (all Roche). Material and methods: 41 fresh canine blood specimens submitted from the Clinic for Small Animals, Justus-Liebig-University Giessen were included. Measurement of fibrin D-dimers with the Liatest™ D-Di™ immunoturbidimetric assay was performed in citrated blood plasma stored at –80 °C until analysis. Using the Cardiac reader, D-dimer plasma concentrations were measured with an immunological assay in heparinized fresh (< 1 hour) whole blood specimens. Results: Mean intra-assay coefficient of variation (CV) was 6.13% (range: 2.2–10.0%) for the Liatest™ D-Di and 19.8% (range: 20.1–19.6%) for the Cardiac reader. Fibrin D-dimers detected with the STA Compact exceeded the upper limit of the reference interval (0.4 μg/ml; n = 62 healthy dogs) in 20/41 samples. There was a fair correlation between D-dimer measurements with the Cardiac reader and the comparison method (r = 0.78). Generally, results were underestimated with a mean proportional bias (0.45 μg/ml). The area under the Receiver Operating Characteristic (ROC) curve was 0.895 regarding the detection of increased fibrin D-dimers with the Cardiac reader. At a cut-off value of > 0.2 μg/ml, sensitivity/specificity were 85%/91% and positive/negative likelihood ratios were 8.93/0.17. At a lower cut-off value of 0.15 μg/ml sensitivity and specificity were 90% and 66%, respectively. Conclusion and clinical relevance: The Cardiac reader can be used for quantitative measurement of canine D-dimers, however, due to the odds of false negative results and the high imprecision the comparison method should be preferred.

scholarly journals Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an Emergency Department

2021 ◽  
Author(s):  
Jean-Claude Nguyen Van ◽  
Camille Gerlier ◽  
Benoit Pilmis ◽  
Assaf Mizrahi ◽  
Gauthier Pean de Ponfilly ◽  
...  
Keyword(s):  
Emergency Department ◽  
Point Of Care ◽  
False Negative ◽  
Study Participant ◽  
Reference Method ◽  
Rt Pcr ◽  
Point Of Care Test ◽  
Viral Transport Medium ◽  
Sensitivity Specificity ◽  
User Friendly

Background : Rapid testing for COVID-19 has been clearly identified as an essential component of the strategy to control the SARS-CoV-2 epidemic, worldwide. The ID NOW COVID-19 assay is a simple, user-friendly, rapid molecular biology test based on nicking and extension amplification reaction (NEAR). Objectives : The aim of this study was to evaluate the ID NOW COVID-19 assay when used as a point-of-care test (POCT) in our Emergency Department (ED). Type of study : This prospective study enrolled 395 consecutive patients; paired nasopharyngeal swabs were collected from each study participant. The first swab was tested with the ID NOW COVID-19 assay at the point-of-care by ED nurses. The second swab was diluted in viral transport medium (VTM) and sent to the clinical microbiology department for analysis by both the RT-PCR Simplexa test COVID-19 Direct assay as the study reference method, and the ID NOW COVID-19 assay performed in the laboratory. Results : Nasopharyngeal swabs directly tested with the ID NOW COVID-19 assay yielded a sensitivity, specificity, PPV and NPV of 98.0%, 97.5%, 96.2% and 98.7%, respectively, in comparison with the RT-PCR study reference assay. When the ID NOW COVID-19 assay was performed in the laboratory using the VTM samples, the sensitivity decreased to 62.5% and the NPV to 79.7%. Three false negative test results were reported with the ID NOW COVID-19 assay when performed using undiluted swabs directly in the ED; these results were obtained from patients with elevated CT values (>30). Conclusion : We demonstrated that the ID NOW COVID-19 assay, performed as a point of care test in the ED using dry swabs, provides a rapid and reliable alternative to laboratory-based RT-PCR methods

Transcutaneous Bilirubin Monitoring in Preterm Infants of 23 to 34 Weeks' Gestation

2021 ◽  
Author(s):  
Jennifer Weber ◽  
Nataly Vadasz-Chates ◽  
Christine Wade ◽  
Becky Micetic ◽  
Richard Gerkin ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Medical Center ◽  
Characteristic Curve ◽  
Standard Of Care ◽  
Receiver Operator Characteristic Curve ◽  
Total Serum ◽  
Predictive Values ◽  
Transcutaneous Bilirubin ◽  
Sensitivity Specificity ◽  
A Prospective Study

Objective The study aimed to evaluate the validity of transcutaneous bilirubin (TcB) measurements at three sites in premature infants born at 230/7 to 346/7 weeks' gestational age (GA) compared with total serum bilirubin (TSB) measurements. Study Design A prospective study was conducted at Banner – University Medical Center Phoenix, where informed consent was obtained from the infant's parent or legally authorized representative. Cohort A was comprised of infants 230/7 to 286/7 weeks' GA and Cohort B contained subjects 290/7 to 346/7 weeks' GA. Baseline TSB measurements were collected at approximately 24 hours of life, as the standard of care and the TcB measurements were obtained from the sternum, interscapular, and buttock areas at approximately ± 30 minutes from collection of the TSB. Statistical analysis of measurements including sensitivity, specificity, positive, and negative predictive values, and the area under the receiver operator characteristic curve (AUROC) were performed. Results A total of 166 infants were included in the study population. Cohort A consisted of 41 subjects and Cohort B contained 125 subjects. The results showed that baseline TcB measurements from the interscapular area were the most sensitive and specific with TSB levels >5.0 mg/dL in Cohort A. Baseline TcB measurements from the sternum demonstrated greatest sensitivity and specificity when the TSB level was >8.0 mg/dL in Cohort B. In general, each of the three sites in both cohorts demonstrated excellent AUROCs and negative predictive values. Conclusion The use of a TcB meter in preterm infants can be a reliable noninvasive screening tool for hyperbilirubinemia, and it may be beneficial in decreasing painful stimuli and iatrogenic blood loss when used as an adjunct to TSB monitoring. Key Points

scholarly journals Evaluation of saliva molecular point of care for detection of SARS-CoV-2 in ambulatory care

2021 ◽  
Author(s):  
Jérôme LeGoff ◽  
Solen Kernéis ◽  
Caroline Elie ◽  
Séverine Mercier Delarue ◽  
Nabil Gastli ◽  
...  
Keyword(s):  
Point Of Care ◽  
False Negative ◽  
Lamp Assay ◽  
Rapid Identification ◽  
Nasopharyngeal Swab ◽  
Lower Sensitivity ◽  
Rt Pcr ◽  
Registration Number ◽  
A Prospective Study ◽  
Antigen Testing

Abstract Background Rapid identification of SARS-Cov-2 infected individuals is a cornerstone for the control of virus spread. The sensitivity of SARS-CoV-2 RNA detection by RT-PCR is similar in saliva and nasopharyngeal swab. Rapid molecular point-of-care tests in saliva could facilitate, broaden and speed up the diagnosis. Methods We conducted a prospective study in two community COVID-19 screening centers to evaluate the performances of a CE-marked RT-LAMP assay (EasyCoV™) designed for the detection of SARS-CoV2 RNA from fresh saliva samples, compared to nasopharyngeal RT-PCR, to saliva RT-PCR and to nasopharyngeal antigen testing. Results Overall, 117 of the 1718 participants (7%) were tested positive with nasopharyngeal RT-PCR. Compared to nasopharyngeal RT-PCR, the sensitivity and specificity of the RT-LAMP assay in saliva were 34% and 97% respectively. The Ct values of nasopharyngeal RT-PCR were significantly lower in the 40 true positive subjects with saliva RT-LAMP (Ct 25.9) than in the 48 false negative subjects with saliva RT-LAMP (Ct 28.4) (p = 0.028). Considering six alternate criteria for reference test, including saliva RT-PCR and nasopharyngeal antigen, the sensitivity of saliva RT-LAMP ranged between 27 and 44%. Conclusion The detection of SARS-CoV-2 from crude saliva samples with a RT-LAMP assay had a lower sensitivity than nasopharyngeal RT-PCR, saliva RT-PCR and nasopharyngeal antigen testing. Registration number : NCT04578509

The role of serum periostin in the diagnosis of asthma: A meta-analysis

2020 ◽  
Vol 41 (4) ◽  
pp. 240-247
Author(s):  
Lei Yang ◽  
Qingtao Zhao ◽  
Shuyu Wang
Keyword(s):  
Diagnostic Accuracy ◽  
Meta Analysis ◽  
Characteristic Curve ◽  
False Negative ◽  
Summary Receiver Operating Characteristic ◽  
True Negative ◽  
Negative Results ◽  
Noninvasive Biomarker ◽  
Sensitivity Specificity ◽  
Serum Periostin

Background: Serum periostin has been proposed as a noninvasive biomarker for asthma diagnosis and management. However, its accuracy for the diagnosis of asthma in different populations is not completely clear. Methods: This meta-analysis aimed to evaluate the diagnostic accuracy of periostin level in the clinical determination of asthma. Several medical literature data bases were searched for relevant studies through December 1, 2019. The numbers of patients with true-positive, false-positive, false-negative, and true-negative results for the periostin level were extracted from each individual study. We assessed the risk of bias by using Quality Assessment of Diagnostic Accuracy Studies 2. We used the meta-analysis to produce summary estimates of accuracy. Results: In total, nine studies with 1757 subjects met the inclusion criteria. The pooled estimates of sensitivity, specificity, and diagnostic odds ratios for the detection of asthma were 0.58 (95% confidence interval [CI], 0.38‐0.76), 0.86 (95% CI, 0.74‐0.93), and 8.28 (95% CI, 3.67‐18.68), respectively. The area under the summary receiver operating characteristic curve was 0.82 (95% CI, 0.79‐0.85). And significant publication bias was found in this meta‐analysis (p = 0.39). Conclusion: Serum periostin may be used for the diagnosis of asthma, with moderate diagnostic accuracy.

scholarly journals COVID-19 Seroprevalence among Healthcare Workers of a Large COVID-19 Hospital in Rome Reveals Strengths and Limits of Two Different Serological Tests

2021 ◽  
Vol 18 (5) ◽  
pp. 2650
Author(s):  
Giuseppe Vetrugno ◽  
Daniele Ignazio La Milia ◽  
Floriana D’Ambrosio ◽  
Marcello Di Pumpo ◽  
Roberta Pastorino ◽  
...  
Keyword(s):  
Blood Test ◽  
Healthcare Workers ◽  
Point Of Care ◽  
Venous Blood ◽  
Administrative Staff ◽  
Serological Tests ◽  
Predictive Values ◽  
Work From Home ◽  
Significant Difference ◽  
Sensitivity Specificity

Healthcare workers are at the forefront against COVID-19, worldwide. Since Fondazione Policlinico Universitario A. Gemelli (FPG) IRCCS was enlisted as a COVID-19 hospital, the healthcare workers deployed to COVID-19 wards were separated from those with limited/no exposure, whereas the administrative staff were designated to work from home. Between 4 June and 3 July 2020, an investigation was conducted to evaluate the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin (IgG) antibodies among the employees of the FPG using point-of-care (POC) and venous blood tests. Sensitivity, specificity, and predictive values were determined with reverse-transcription polymerase chain reaction on nasal/oropharyngeal swabs as the diagnostic gold standard. The participants enrolled amounted to 4777. Seroprevalence was 3.66% using the POC test and 1.19% using the venous blood test, with a significant difference (p < 0.05). The POC test sensitivity and specificity were, respectively, 63.64% (95% confidence interval (CI): 62.20% to 65.04%) and 96.64% (95% CI: 96.05% to 97.13%), while those of the venous blood test were, respectively, 78.79% (95% CI: 77.58% to 79.94%) and 99.36% (95% CI: 99.07% to 99.55%). Among the low-risk populations, the POC test’s predictive values were 58.33% (positive) and 98.23% (negative), whereas those of the venous blood test were 92.86% (positive) and 98.53% (negative). According to our study, these serological tests cannot be a valid alternative to diagnose COVID-19 infection in progress.

scholarly journals Comparison of 2D Fat Suppressed Proton Density (FS-PD) and 3D (WATS-c) MRI pulse sequences in evaluation of chondromalacia patellae

2019 ◽  
Vol 50 (1) ◽  
Author(s):  
Ahmed Ibrahim Tawfik ◽  
Wael Hamza Kamr ◽  
Saher Ebrahim Taman
Keyword(s):  
Diagnostic Performance ◽  
False Negative ◽  
Pulse Sequences ◽  
Proton Density ◽  
Grading System ◽  
Reference Standard ◽  
Mr Images ◽  
Arthroscopic Findings ◽  
Chondromalacia Patella ◽  
Sensitivity Specificity

Abstract Background Comparing the diagnostic performance of widely used 2D FSE technique (fat-suppressed proton density; FS-PD) and the 3D technique (water-selective cartilage scan; WATS-c) in evaluation of the chondromalacia patella by using arthroscopy as reference standard Results Seventy-five adult patients were enrolled in this study. They underwent MRI examinations then arthroscopy done in 2–4 days after it. MRI was done using 2D (FS-PD) and 3D (WATS-c) sequences and MR images were compared by two radiologists separately, then grading of the cartilage lesions was performed according to modified Noyes grading system and comparison between grade 0–1, 2, and 3 lesions was done using arthroscopic findings as a reference. A false-negative result is considered if there was undergrading of chondromalacia and false-positive result if chondromalacia was overgraded. Each sequence sensitivity, specificity, and accuracy was calculated by both readers. For reader 1, the sensitivity is 69% for WATS-c and 80% for FS-PD and the accuracy is 90% for WATS-c and 92% for FS-PD and for reader 2, the sensitivity is 56% for WATS-c and 84% for FS-PD and the accuracy is 88% for WATS-c and 94% for FS-PD. Conclusion 2D FS-PD images showed better diagnostic performance than 3D WATS-c images for evaluating chondromalacia patella.

scholarly journals Essential properties and pitfalls of colorimetric Reverse Transcription Loop-mediated Isothermal Amplification as a point-of-care test for SARS-CoV-2 diagnosis

2021 ◽  
Vol 27 (1) ◽  
Author(s):  
Bruna de Oliveira Coelho ◽  
Heloisa Bruna Soligo Sanchuki ◽  
Dalila Luciola Zanette ◽  
Jeanine Marie Nardin ◽  
Hugo Manuel Paz Morales ◽  
...  
Keyword(s):  
Viral Load ◽  
Internal Control ◽  
Reverse Transcription ◽  
Color Change ◽  
Point Of Care ◽  
Colorimetric Detection ◽  
False Negative ◽  
Isothermal Amplification ◽  
Clinical Samples ◽  
Loop Mediated Isothermal Amplification

Abstract Background SARS-CoV-2 Reverse Transcription Loop-mediated Isothermal Amplification (RT-LAMP) colorimetric detection is a sensitive and specific point-of-care molecular biology technique used to detect the virus in only 30 min. In this manuscript we have described a few nuances of the technique still not properly described in the literature: the presence of three colors clusters; the correlation of the viral load with the color change; and the importance of using an internal control to avoid false-negative results. Methods To achieve these findings, we performed colorimetric RT-LAMP assays of 466 SARS-CoV-2 RT-qPCR validated clinical samples, with color quantification measured at 434 nm and 560 nm. Results First we determinate a sensitivity of 93.8% and specificity of 90.4%. In addition to the pink (negative) and yellow (positive) produced colors, we report for the first time the presence of an orange color cluster that may lead to wrong diagnosis. We also demonstrated using RT-qPCR and RT-LAMP that low viral loads are related to Ct values > 30, resulting in orange colors. We also demonstrated that the diagnosis of COVID-19 by colorimetric RT-LAMP is efficient until the fifth symptoms day when the viral load is still relatively high. Conclusion This study reports properties and indications for colorimetric RT-LAMP as point-of-care for SARS-CoV-2 diagnostic, reducing false results, interpretations and optimizing molecular diagnostics tests application.

Usefulness of point-of-care ultrasound in military medical emergencies performed by young military medicine residents

2019 ◽  
pp. jramc-2018-001132
Author(s):  
Pierre Perrier ◽  
J Leyral ◽  
O Thabouillot ◽  
D Papeix ◽  
G Comat ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Clinical Examination ◽  
Point Of Care ◽  
Military Medicine ◽  
Final Diagnosis ◽  
Absolute Difference ◽  
Point Of Care Ultrasound ◽  
Medical Emergencies ◽  
The Mean ◽  
A Prospective Study

IntroductionTo evaluate the usefulness of point-of-care ultrasound (POCUS) performed by young military medicine residents after short training in the diagnosis of medical emergencies.MethodsA prospective study was performed in the emergency department of a French army teaching hospital. Two young military medicine residents received ultrasound training focused on gall bladder, kidneys and lower limb veins. After clinical examination, they assigned a ‘clinicaldiagnostic probability’ (CP) on a visual analogue scale from 0 (definitely not diagnosis) to 10 (definitive diagnosis). The same student performed ultrasound examination and assigned an ‘ultrasounddiagnostic probability’ (UP) in the same way. The absolute difference between CP and UP was calculated. This result corresponded to the Ultrasound Diagnostic Index (UDI), which was positive if UP was closer to the final diagnosis than CP (POCUS improved the diagnostic accuracy), and negative conversely (POCUS decreased the diagnostic accuracy).ResultsForty-eight patients were included and 48 ultrasound examinations were performed. The present pathologies were found in 14 patients (29%). The mean UDI value was +3 (0–5). UDI was positive in 35 exams (73%), zero in 12 exams (25%) and negative in only one exam (2%).ConclusionPOCUS performed after clinical examination increases the diagnostic accuracy of young military medicine residents.

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