scholarly journals Evaluation of the MP Rapid 2019-NCOV IgM/IgG combo POCT test vs. an established platform-based method

2021 ◽  
pp. 000456322199555
Author(s):  
N Jassam ◽  
JH Barth ◽  
V Allgar ◽  
S Glover ◽  
F Stevenson ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Capillary Blood ◽  
Complete Agreement ◽  
Previous Exposure ◽  
Rapid Testing ◽  
High Confidence ◽  
Serum Samples ◽  
Negative Controls ◽  
Near Patient Testing

Background Accurate and rapid testing for SARS-COV-2 antibodies could improve the diagnosis and management of COVID-19. In this study, we aim to evaluate the diagnostic accuracy of a commercially available point-of-care lateral flow kit independently and in comparison to an established platform-based system. Method Samples from 144 PCR-confirmed COVID-19 cases and 130 pre-pandemic negative controls were tested in parallel by MP Rapid 2019-NCOV IgM/IgG Combo test and Roche Elecsys. Comparison of results based on serum and capillary blood testing was undertaken. Results Sensitivity at day 15 onwards was 100% for both methods. Between days 1 and 7 post admission, the IgM/IgG Combo test and Roche Elecsys shown sensitivity of 74% (95% CI: 62%-85%) vs. 67% (95% CI: 55%–79%, P =  0.3947). Combo test specificities were 100% for IgG, 98.5% for IgM vs. Roche Elecsys specificity of 100%. Concordance analysis showed 98.5% agreement to the Roche Elecsys method (Cohen’s Kappa 0.96 95% CI [0.92–0.99]). Capillary blood results showed complete agreement with serum samples using the Combo test. Conclusion In comparison to Roche Elecsys, our data show that the MP Rapid 2019-NCOV IgM/IgG Combo test provides a high-confidence assay system for the detection of previous exposure to SARS-COV-2 infection with advantage of affording near-patient testing.

scholarly journals Quality control and quality assurance for point of care (POC) diagnostic tests

2006 ◽  
Vol 27 (2) ◽  
pp. 58
Author(s):  
William Rawlinson ◽  
Ros Escott ◽  
Cristina Baleriola ◽  
Arthur Morris
Keyword(s):  
Quality Control ◽  
Diagnostic Tests ◽  
Point Of Care ◽  
Rapid Testing ◽  
Central Laboratory ◽  
Self Testing ◽  
Wide Range ◽  
Bedside Testing ◽  
Testing Patient ◽  
Near Patient Testing

Point of care (POC) tests are those performed outside a central laboratory, using testing devices that are easily transportable to perform testing near where the patient is located. POC testing is also known as near patient testing, patient self testing, rapid testing and bedside testing. This definition involves a wide range of types of POC testing.

scholarly journals P342 Correlation of the first lateral flow-based Point of Care test to quantify infliximab and anti-infliximab antibodies in a finger prick sample with the reference ELISA technique

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S366-S366
Author(s):  
M B Ruiz-Argüello ◽  
J Pascual ◽  
L Del Río ◽  
A Urigoitia ◽  
C Balo Farto ◽  
...  
Keyword(s):  
Correlation Coefficient ◽  
Point Of Care ◽  
Pearson Correlation ◽  
Capillary Blood ◽  
Lateral Flow ◽  
Real Point ◽  
Infliximab Treatment ◽  
Serum Samples ◽  
Finger Prick ◽  
Elisa Technique

Abstract Background The goal of this study was to validate the use of capillary blood in a real point-of-care (POC) setting for patients under infliximab treatment by using Promonitor Quick lateral flow (LF) tests. Results were compared to the Promonitor ELISA reference technique in serum samples used by centralised laboratories. Methods A prospective, observational study was designed to evaluate the performance of a rapid LF test (Promonitor Quick IFX, Progenika, Spain). 160 infliximab treated rheumatology consecutive patients (400 samples) were recruited in two hospitals in Galicia, Spain. Prior to the infusion, a finger prick sample was obtained and analysed. Anti-infliximab antibodies were also determined with Promonitor Quick ANTI-IFX1-4. Results were read with the automated portable PQreader instrument. Additionally, a serum sample was collected for subsequent comparative analysis with either LF or ELISA tests. Qualitative (positive (PPA) and negative (NPA) agreements) and quantitative (Pearson correlation and bias) performance of the LF test was compared to ELISA, as well as between different specimens following CLSI EP09-A3. Results Overall agreement between Promonitor Quick IFX finger prick and ELISA test was 91% (88% PPA; 100% NPA). The quantitative comparison showed a good correlation (Pearson correlation coefficient: 0.85 and observed bias: 25%) (Table 1). Similar results were also observed when serum was used with either the LF or the ELISA tests (98% overall agreement, 0.91 correlation coefficient; 6% bias) (Table 1). Overall agreements for visual and automated (PQreader) interpretations with Promonitor Quick ANTI-IFX were 99% and 100% for finger prick and serum specimens, respectively (Table 2). Conclusion Promonitor Quick can be used to reliably quantify infliximab in capillary blood samples and results are comparable to those obtained with the reference ELISA technique. The use of the rapid POC test with finger prick will allow clinicians to monitor their patients in a fully decentralized mode to aid in the decision making process. PQreader is a sensitive portable equipment to report drug as well as antibody levels in the patient samples. References

scholarly journals Evaluation of SARS-CoV-2 Antibody Point of Care Devices in the Laboratory and Clinical Setting

2021 ◽  
Author(s):  
Kirsty McCance ◽  
Helen Wise ◽  
Jennifer Simpson ◽  
Becky Bachelor ◽  
Harriet Hale ◽  
...  
Keyword(s):  
Immune Status ◽  
Point Of Care ◽  
Capillary Blood ◽  
Serum Samples ◽  
Specificity And Sensitivity ◽  
Independent Evaluation ◽  
Positive Antibody ◽  
Antibody Titres ◽  
Paired Serum ◽  
Antibody Tests

SARS-CoV-2 Antibody tests have been marketed to diagnose previous SARS-CoV-2 infection and as a test of immune status. There is a lack of evidence on the performance and clinical utility of these tests. We aimed to carry out an evaluation of 14 point of care (POC) SARS-CoV-2 antibody tests. Serum from participants with previous RT-PCR (Real-Time Polymerase chain reaction) confirmed SARS-CoV-2 infection and pre-pandemic controls were used to determine specificity and sensitivity of each POC device. Changes in sensitivity with increasing time from infection were determined on a cohort of participants. Corresponding neutralising antibody status was measured to establish whether the detection of antibodies by the POC device correlated with immune status. Paired capillary and serum samples were collected to ascertain whether POC devices performed comparably on capillary samples. Sensitivity and specificity varied between the POC devices and in general did not meet the manufacturers reported performance characteristics signifying the importance of independent evaluation of these tests. The sensitivity peaked at >20 days following symptoms onset however sensitivity of 3 POC devices evaluated at extended time points showed that sensitivity declined with time and this was particularly marked at >140 days post infection onset. This is relevant if the tests are to be used for sero-prevelence studies. Neutralising antibody data showed positive antibody results on POC devices did not necessarily confer high neutralising antibody titres and these POC devices cannot be used to determine immune status to the SARS-CoV-2 virus. Comparison of paired serum and capillary results showed that there was a decline in sensitivity using capillary blood. This has implications in the utility of the test as they are designed to be used on capillary blood by the general population.

scholarly journals Improved diagnostic accuracy of pathology with the implementation of a perioperative point-of-care ultrasound service: quality improvement initiative

2019 ◽  
pp. rapm-2019-100632 ◽  
Author(s):  
Davinder Ramsingh ◽  
Alec Runyon ◽  
Jason Gatling ◽  
Ihab Dorotta ◽  
Ryan Lauer ◽  
...  
Keyword(s):  
Quality Improvement ◽  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Complete Agreement ◽  
Point Of Care Ultrasound ◽  
Successful Implementation ◽  
Online Curriculum ◽  
Diagnostic Studies ◽  
New Diagnosis ◽  
Higher Sensitivity

IntroductionThe utility of perioperative point-of-care ultrasound (P-POCUS) is rapidly growing. The successful implementation of a comprehensive P-POCUS curriculum, Focused PeriOperative Risk Evaluation Sonography Involving Gastro-abdominal, Hemodynamic, and Trans-thoracic Ultrasound (FORESIGHT), has been demonstrated. This project sought to further evaluate the utility of P-POCUS with the following aims: (1) to assess the ability to train the FORESIGHT curriculum via a free, open-access, online platform; (2) to launch a P-POCUS clinical service as a quality improvement (QI) initiative; (3) to evaluate the diagnostic accuracy of the P-POCUS examinations to formal diagnostic studies; and (4) to compare the P-POCUS diagnostic accuracy with the diagnostic accuracy of traditional assessment (TA).MethodsThis study was launched as a QI project for the implementation of a P-POCUS service. A group of attending and resident anesthesiologists completed P-POCUS training supported by an online curriculum. After training, a P-POCUS service was launched. The P-POCUS service was available for any perioperative event, and specific triggers were also identified. All examinations were documented on a validated datasheet. The diagnostic accuracy of the two index tests, P-POCUS and TA, were compared with formal diagnostic testing. TA was defined as a combination of the anesthesiologist’s bedside assessment and physical examination. The primary outcome marker was a comparison in the accuracy of new diagnosis detected by P-POCUS service versus the TA performed by the primary anesthesiologist.ResultsA total of 686 P-POCUS examinations were performed with 466 examinations having formal diagnostic studies for comparison. Of these, 92 examinations were detected as having new diagnoses. Performance for detection of a new diagnosis demonstrated a statistically higher sensitivity for the P-POCUS examinations (p<0.0001). Performance comparison of all P-POCUS examinations that were matched to formal diagnostic studies (n=466) also demonstrated a significantly higher sensitivity. These findings were consistent across cardiovascular, pulmonary and abdominal P-POCUS categories (p<0.01). Additionally, multiple pathologies demonstrated complete agreement between the P-POCUS examination and the formal study.ConclusionA P-POCUS service can be developed after training facilitated by an online curriculum. P-POCUS examinations can be performed by anesthesiologists with a high degree of accuracy to formal studies, which is superior to TA.

scholarly journals Development of a New Lateral Flow Assay Based on IBMP-8.1 and IBMP-8.4 Chimeric Antigens to Diagnose Chagas Disease

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Edimilson D. Silva ◽  
Ângelo A. O. Silva ◽  
Emily F. Santos ◽  
Leonardo M. Leony ◽  
Natália E. M. Freitas ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Chagas Disease ◽  
Large Scale ◽  
Point Of Care ◽  
Lateral Flow ◽  
International Standards ◽  
Study Phase ◽  
Serum Samples ◽  
Serological Screening ◽  
Diagnostic Potential

Despite several available methodologies for Chagas disease (CD) serological screening, the main limitation of chronic CD diagnosis is the lack of effective tools for large-scale screening and point-of-care diagnosis to be used in different CD epidemiological scenarios. Taking into account that developing such a diagnostic tool will significantly improve the ability to identify CD carriers, we aimed at performing a proof-of-concept study (phase I study) to assess the use of these proteins in a point-of-care platform using serum samples from different geographical settings of Brazil and distinct clinical presentations. The diagnostic accuracy study was conducted on a panel of two WHO International Standards (IS) and 14 sera from T. cruzi-positive and 16 from T. cruzi-negative individuals. The results obtained with the test strips were converted to digital images, allowing quantitative comparison expressed as a relative band intensity ratio (RBI). The diagnostic potential and performance were also determined. Regardless of the geographical origin or clinical presentation, all sera with T. cruzi antibodies returned positive both for IBMP-8.1 and IBMP-8.4 chimeric antigens. The area under the ROC curve (AUC) values was 100% for both antigens, demonstrating an outstanding overall diagnostic accuracy (100%). Based on the data, we believe that the lateral flow assays based on these antigens are promising methodologies for screening CD.

Ferromagnetic Resonance Biosensor for Homogeneous and Volumetric Detection of DNA

2017 ◽  
Author(s):  
Bo Tian ◽  
Peter Svedlindh ◽  
Mattias Strömberg ◽  
Erik Wetterskog
Keyword(s):  
Magnetic Nanoparticles ◽  
Ferromagnetic Resonance ◽  
Limit Of Detection ◽  
Point Of Care ◽  
Rolling Circle Amplification ◽  
Resonance Field ◽  
Isothermal Amplification ◽  
Detection Sensitivity ◽  
Serum Samples ◽  
Rolling Circle

In this work, we demonstrate for the first time, a ferromagnetic resonance (FMR) based homogeneous and volumetric biosensor for magnetic label detection. Two different isothermal amplification methods, <i>i.e.</i>, rolling circle amplification (RCA) and loop-mediated isothermal amplification (LAMP) are adopted and combined with a standard electron paramagnetic resonance (EPR) spectrometer for FMR biosensing. For RCA-based FMR biosensor, binding of RCA products of a synthetic Vibrio cholerae target DNA sequence gives rise to the formation of aggregates of magnetic nanoparticles. Immobilization of nanoparticles within the aggregates leads to a decrease of the net anisotropy of the system and a concomitant increase of the resonance field. A limit of detection of 1 pM is obtained with an average coefficient of variation of 0.16%, which is superior to the performance of other reported RCA-based magnetic biosensors. For LAMP-based sensing, a synthetic Zika virus target oligonucleotide is amplified and detected in 20% serum samples. Immobilization of magnetic nanoparticles is induced by their co-precipitation with Mg<sub>2</sub>P<sub>2</sub>O<sub>7</sub> (a by-product of LAMP) and provides a detection sensitivity of 100 aM. The fast measurement, high sensitivity and miniaturization potential of the proposed FMR biosensing technology makes it a promising candidate for designing future point-of-care devices.<br>

scholarly journals A Label and Probe-Free Zika Virus Immunosensor Prussian Blue@carbon Nanotube-Based for Amperometric Detection of the NS2B Protein

Biosensors ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. 157
Author(s):  
Bárbara V. M. Silva ◽  
Marli T. Cordeiro ◽  
Marco A. B. Rodrigues ◽  
Ernesto T. A. Marques ◽  
Rosa F. Dutra
Keyword(s):  
Carbon Nanotube ◽  
Prussian Blue ◽  
Zika Virus ◽  
Point Of Care ◽  
Amperometric Detection ◽  
Cross Reactivity ◽  
Structural Protein ◽  
Serum Samples ◽  
Polypyrrole Composite ◽  
Congenital Disabilities

Zika virus (ZIKV) is a mosquito-borne infection, predominant in tropical and subtropical regions causing international concern due to the ZIKV disease having been associated with congenital disabilities, especially microcephaly and other congenital abnormalities in the fetus and newborns. Development of strategies that minimize the devastating impact by monitoring and preventing ZIKV transmission through sexual intercourse, especially in pregnant women, since no vaccine is yet available for the prevention or treatment, is critically important. ZIKV infection is generally asymptomatic and cross-reactivity with dengue virus (DENV) is a global concern. An innovative screen-printed electrode (SPE) was developed for amperometric detection of the non-structural protein (NS2B) of ZIKV by exploring the intrinsic redox catalytic activity of Prussian blue (PB), incorporated into a carbon nanotube–polypyrrole composite. Thus, this immunosensor has the advantage of electrochemical detection without adding any redox-probe solution (probe-less detection), allowing a point-of-care diagnosis. It was responsive to serum samples of only ZIKV positive patients and non-responsive to negative ZIKV patients, even if the sample was DENV positive, indicating a possible differential diagnosis between them by NS2B. All samples used here were confirmed by CDC protocols, and immunosensor responses were also checked in the supernatant of C6/36 and in Vero cell cultures infected with ZIKV.

scholarly journals Diagnostic Significance of Serum Galectin-3 in Hospitalized Patients with COVID-19—A Preliminary Study

Biomolecules ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 1136
Author(s):  
Beata Kuśnierz-Cabala ◽  
Barbara Maziarz ◽  
Paulina Dumnicka ◽  
Marcin Dembiński ◽  
Maria Kapusta ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Hospital Stay ◽  
Tissue Injury ◽  
Immunological Response ◽  
Organ Injury ◽  
Quantitative Detection ◽  
Serum Samples ◽  
Diagnostic Significance ◽  
Galectin 3 ◽  
Preliminary Study

Severe coronavirus disease 2019 (COVID-19) is associated with hyperinflammation leading to organ injury, including respiratory failure. Galectin-3 was implicated in innate immunological response to infections and in chronic fibrosis. The aim of our preliminary study was the assessment of the diagnostic utility of serum galectin-3 in patients with COVID-19. The prospective observational study included adult patients admitted with active COVID-19 and treated in tertiary hospital between June and July 2020. The diagnosis was confirmed by the quantitative detection of nucleic acid of severe acute respiratory syndrome coronavirus 2 in nasopharyngeal swabs. Galectin-3 was measured by enzyme immunoassay in serum samples obtained during the first five days of hospital stay. We included 70 patients aged 25 to 73 years; 90% had at least one comorbidity. During the hospital stay, 32.9% were diagnosed with COVID-19 pneumonia and 12.9% required treatment in the intensive care unit (ICU). Serum galectin-3 was significantly increased in patients who developed pneumonia, particularly those who required ICU admission. Positive correlations were found between galectin-3 and inflammatory markers (interleukin-6, C-reactive protein, ferritin, pentraxin-3), a marker of endothelial injury (soluble fms-like tyrosine kinase-1), and a range of tissue injury markers. Serum galectin-3 enabled the diagnosis of pneumonia with moderate diagnostic accuracy and the need for ICU treatment with high diagnostic accuracy. Our findings strengthen the hypothesis that galectin-3 may be involved in severe COVID-19. Further studies are planned to confirm the preliminary results and to verify possible associations of galectin-3 with long-term consequences of COVID-19, including pulmonary fibrosis.

scholarly journals Role of human epididymis protein 4 for detection of ovarian carcinoma in adnexal masses: A pilot study

2016 ◽  
Author(s):  
Nidhi Bansal ◽  
A. Suneja ◽  
K. Guleria ◽  
N. B. Vaid ◽  
K. Mishra ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Cross Sectional Study ◽  
Ca 125 ◽  
Serum Samples ◽  
Cross Sectional ◽  
Adnexal Masses ◽  
Good Discriminator ◽  
Risk Of Malignancy ◽  
Risk Of Malignancy Index ◽  
Benign Tumours

Introduction: HE4 is a novel tumour biomarker used for early diagnosis of ovarian cancer. This study evaluated the diagnostic accuracy of HE4 alone and in combination with CA125, risk of malignancy index (RMI), risk of malignancy algorithm (ROMA). Methods: It was a cross sectional study conducted recruiting 88 women with adnexal masses who were planned for surgery. After baseline work up and ultrasound examination, serum samples were collected for estimation of CA 125 and HE4 levels. Serum HE4 levels were estimated using ELISA kit. RMI and ROMA score were calculated and diagnostic accuracy of HE4, CA 125, RMI, ROMA and their combination were compared. Cut off for HE4 and ROMA score were calculated using ROC curve. Results: Of 88 subjects, 66 were analyzed with 19 malignant (including 5 LMP) and 47 benign cases. The median value of HE4 among malignant cases was found to be significantly higher than among the benign cases. PPV and NPV of HE4 at a cut off 130.8 pMol/ml was 85.7% and 77.9% respectively. Highest PPV (88.9%) with acceptable NPV (80.7%) was found with ROMA followed by HE4 (PPV 85.7%; NPV 77.97%), RMI (PPV 76.92%; NPV 83%) and CA125 (PPV 52%; NPV 80.85%). Conclusion: HE4 levels were lower in Indian population both in malignant and benign tumours as compared to other studies. HE4 is a good discriminator and gives best accuracy when it is combined with CA125 in a logistic algorithm, ROMA.

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