Point-of-care serological assays for SARS-CoV-2 in a UK hospital population: potential for enhanced case finding

Abstract Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic, causing over 3,600,000 reported cases and 250,000 deaths worldwide.1 Case identification has predominantly been made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but independent validation is urgently required to assess their utility. Where a plurality of point-of-care (POC) SARS-CoV-2 antibody test kits have become available, we will therefore aim to evaluate a range of kits against the current available gold-standard diagnostic test of PCR in an initial, exploratory study. We will then proceed to carry out testing with 200 hospital inpatients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette against PCR in order to undergo a preliminary evaluation of POC serological test performance characteristics within a hospital inpatient cohort.

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Point-of-care serological assays for SARS-CoV-2 in a UK hospital population: potential for enhanced case finding

10.21203/rs.3.rs-28006/v1 ◽

2020 ◽

Cited By ~ 3

Author(s):

Scott Pallett ◽

Sarah Denny ◽

Aatish Patel ◽

Esmita Charani ◽

Nabeela Mughal ◽

...

Keyword(s):

Point Of Care ◽

Rapid Test ◽

Antibody Test ◽

Late Complications ◽

Case Definition ◽

Case Finding ◽

Serological Tests ◽

Specific Patient ◽

Infection Period ◽

Population Potential

Abstract Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Case identification is currently made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but independent validation is urgently required to assess their utility.We evaluated five different point-of-care (POC) SARS-CoV-2 antibody test kits against PCR, finding concordance across the assays (n=15). We subsequently tested 200 patients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette and find a sensitivity of 74% in the early infection period (day 5-9 post symptom onset), with 100% sensitivity not seen until day 13. Specificity was 96%, but in validating the serological tests uncovered potential false-negatives from PCR testing late-presenting cases. A positive predictive value (PPV) of 37% in the general population precludes any use for general screening. Where a case definition is applied however, the PPV is substantially improved (95·4%), supporting use of serology testing in carefully targeted populations. Larger studies in specific patient cohorts, including those with mild infection are urgently required to inform on the applicability of POC serological assays to help control the spread of SARS-CoV-2 and improve case finding of patients that may experience late complications.

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Point-Of-Care Clinical Evaluation of the Clungene® SARS-CoV-2 Virus IgG/IgM 15-minute rapid test cassette with the Cobas® Roche RT-PCR platform in patients with or without Covid-19

LymphoSign Journal ◽

10.14785/lymphosign-2021-0017 ◽

2021 ◽

Author(s):

Fadi Haddad ◽

Christopher C Lamb ◽

Ravina Kullar ◽

George Sakoulas

Keyword(s):

Symptom Onset ◽

Serological Test ◽

Point Of Care ◽

Diagnostic Testing ◽

Rapid Test ◽

Lateral Flow ◽

Added Value ◽

Lateral Flow Immunoassay ◽

Rt Pcr ◽

Past Infection

Background: Covid-19 remains a pandemic with multiple challenges to confirm patient infectivity: lack of sufficient tests, accurate results, validated quality, and timeliness of results. We hypothesize that a rapid 15-minute Point-Of-Care serological test to evaluate past infection complements diagnostic testing for Covid-19 and significantly enhances testing availability. Method: A three arm observational study at Sharp Healthcare, San Diego, California was conducted using the Clungene® lateral flow immunoassay (LFI) and compared with the Cobas® Roche RT PCR results. Arm 1: Thirty-five (35) subjects with confirmed Covid-19 using RT-PCR were tested twice: prior to 14 days following symptom onset and once between 12 and 70 days. Arm 2: Thirty (30) subjects with confirmed Covid-19 using RT-PCR were tested 12-70 days post symptom onset. Arm 3: Thirty (30) subjects with a negative RT-PCR for Covid-19 were tested 1-10 days following the RT-PCR test date. Results: Specificity of confirmed negative Covid-19 by RT-PCR was 100% (95% CI, 88.4%-100.0%); meaning there was 100% negative positive agreement between the RT-PCR and the Clungene® serological test results. Covid-19 subjects tested prior to day 7 symptom onset were antibody negative. In subjects 7-12 days following symptom onset with a confirmed positive Covid-19 by RT-PCR, the combined sensitivity of IgM and IgG was 58.6% (95% CI, 38.9%-76.5%). In subjects 13-70 days following symptom onset with a confirmed positive Covid-19 by RT-PCR the combined sensitivity of IgM and IgG was 90.5% (95% CI, 80.4%-96.4%). Conclusion: The Clungene® lateral flow immunoassay (LFI) is a useful tool to confirm individuals with an adaptive immune response to SARS-CoV-2 indicating past infection. Providing Point-Of-Care results within 15 minutes without any laboratory instrumentation or specialized software has an added value of increasing test availability to patients who have been symptomatic for more than one week to confirm past infection. Performance characteristics are optimal after 13 days with a sensitivity and specificity of 90% and 100%, respectively.

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Is There a Role of Using a Rapid Finger Prick Antibody Test in Screening for Celiac Disease in Children?

Gastroenterology Research and Practice ◽

10.1155/2019/4504679 ◽

2019 ◽

Vol 2019 ◽

pp. 1-5 ◽

Cited By ~ 1

Author(s):

Kristina Baraba Dekanić ◽

Ivona Butorac Ahel ◽

Lucija Ružman ◽

Jasmina Dolinšek ◽

Jernej Dolinšek ◽

...

Keyword(s):

Celiac Disease ◽

Point Of Care ◽

Tissue Transglutaminase ◽

Rapid Test ◽

Antibody Test ◽

First Grade ◽

Iga Deficiency ◽

Iga Antibodies ◽

Point Of Care Tests

Introduction. Celiac disease (CD) is an autoimmune disease triggered by gluten in genetically predisposed individuals. Despite the increasing prevalence of CD, many patients remain undiagnosed. Standard serology tests are expensive and invasive, so several point-of-care tests (POC) for CD have been developed. We aimed to determine the prevalence of CD in first-grade pupils in Primorje-Gorski Kotar County, Croatia, using a POC test. Methods. A Biocard celiac test that detects IgA antibodies to tissue transglutaminase in whole blood was used to screen for celiac disease in healthy first-grade children born in 2011 and 2012 who consumed gluten without restrictions. Results. 1478 children were tested, and none of them were tested positive with a rapid test. In 10 children (0,6%), IgA deficiency has been suspected; only 4 of them agreed to be tested further for total IgA, anti-tTG, and anti-DGP antibodies. IgA deficiency was confirmed in 3 patients, and in all 4 children, CD has been excluded. Conclusion. Our results have not confirmed the usefulness of the POC test in screening the general population of first-grade schoolchildren. Further research is needed to establish the true epidemiology of CD in Primorje-Gorski Kotar County and to confirm the value of the rapid test in comparison with standard antibody CD testing.

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Diagnostic Patterns of Suspected Covid-19 Patients Using Scor Covid-19, PCR Test and Serological Test in Dr. Soetomo Hospital Surabaya, Indonesia

Current Internal Medicine Research and Practice Surabaya Journal ◽

10.20473/cimrj.v2i2.28956 ◽

2021 ◽

Vol 2 (2) ◽

pp. 25

Author(s):

Usman Hadi ◽

Bramantono Bramantono ◽

M Vitanata ◽

Musofa Rusli ◽

Brian Eka Rahman ◽

...

Keyword(s):

General Hospital ◽

Clinical Symptoms ◽

Serological Test ◽

Strong Predictor ◽

Rapid Test ◽

Antibody Test ◽

Radiological Examination ◽

Common Symptom ◽

Abnormal Chest ◽

Pcr Test

Objective: To find out the diagnostic pattern of COVID-19 using RT-PCR or a rapid antibody test in the suspected group patients.Method: The study was conducted in Dr. Soetomo General Hospital (referal hospital for covid-19, 1500 beds). The study used data on patients with suspected covid-19 who were hospitalized at the Dr. Soetomo General Hospital in Surabaya.Result: There were 200 suspected COVID-19 patients enrolled in this study, the main complaints of cough, fever, dyspnoea, around 69.5%, 75%, and 76.5%, respectively. Although not a common symptom, it seems that anosmia (14%) is typical for COVID-19. Based on this scoring system, a total of 196 patients had a high risk of being infected with COVID-19, and 125 (64%) of them finally showed a positive PCR test. PCR test mostly positive (62.5%), while serological test (rapid imunoglobulin test) mostly non reactive, but there were nonsignificant different between PCR and Serological test (p=0.16 OR: 1.5(0.84-71). Furthermore, if we compare the various existing variables, namely the covid-19 score, immunoglobulin rapid test, and radiological examination, only the radiological examination results can be used as a strong predictor of positive PCR results (p=0.005, OR: 1.68 (0.17-16.43).In this study, we found that abnormal chest radiographs are a good parameter for diagnosing COVID-19, (OR: 2.92; 95% CI, 1.34 -6.34).Conclussion: The initial radiological examination combined with the clinical symptoms of Covid-19 is the most important thing to predict the presence of this disease.

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SARS-CoV-2 antibody seroprevalence in Lebanon: findings from the first nationwide serosurvey

BMC Infectious Diseases ◽

10.1186/s12879-022-07031-z ◽

2022 ◽

Vol 22 (1) ◽

Author(s):

Abbas Hoballah ◽

Rana El Haidari ◽

Ghina Siblany ◽

Fadi Abdel Sater ◽

Samir Mansour ◽

...

Keyword(s):

Test Performance ◽

Point Of Care ◽

Vaccination Campaign ◽

Herd Immunity ◽

Age Groups ◽

Rapid Test ◽

Population Based ◽

P Value ◽

Cumulative Number ◽

Population Weight

Abstract Background Lebanon, a small country in the Middle East, remains severely affected by the COVID-19 pandemic. Seroprevalence surveys of anti-SARS-CoV-2 antibodies provide accurate estimates of SARS-CoV-2 infection and hence evaluate the extent of the pandemic. The present study aimed to evaluate the prevalence of SARS-CoV-2 antibodies in Lebanon and to compare the estimated cumulative number of COVID-19 cases with the officially registered number of laboratory-confirmed cases up to January 15, 2021. Methods A nationwide population-based serosurvey study was conducted in Lebanon between December 7, 2020, and January 15, 2021, before the initiation of the national vaccination program. The nCOVID-19 IgG & IgM point-of-care (POCT) rapid test was used to detect the presence of anti-SARS-COV-2 immunoglobulin G (IgG) in the blood. Seroprevalence was estimated after weighting for sex, age, and area of residence and adjusting for the test performance. Results Of the 2058 participants, 329 were positive for IgG SARS-COV-2, resulting in a crude seroprevalence of 16.0% (95% CI 14.4–17.6). The weighed seroprevalence was 15.9% (95% CI of 14.4 and 17.4). After adjusting for test performance, the population weight-adjusted seroprevalence was 18.5% (95% CI 16.8–20.2). This estimate implies that 895,770 individuals of the general population were previously infected by COVID-19 up to January 15, 2021 in Lebanon. The overall estimated number of subjects with previous SARS-CoV-2 infection was three times higher than the officially reported cumulative number of confirmed cases. Seroprevalence was similar across age groups and sexes (p-value > 0.05). However, significant differences were revealed across governorates. Conclusions Our results suggest that the Lebanese population is still susceptible to SARS-CoV-2 infection and far from achieving herd immunity. These findings represent an important contribution to the surveillance of the COVID-19 pandemic in Lebanon and to the understanding of how this virus spreads. Continued surveillance for COVID-19 cases and maintaining effective preventive measures are recommended to control the epidemic spread in conjunction with a national vaccination campaign to achieve the desired level of herd immunity against COVID-19.

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Evaluation of the Truvian Easy Check COVID-19 IgM/IgG Lateral Flow Device for Rapid Anti-SARS-CoV-2 Antibody Detection

American Journal of Clinical Pathology ◽

10.1093/ajcp/aqaa221 ◽

2020 ◽

Author(s):

Clarence W Chan ◽

Sajid Shahul ◽

Cheyenne Coleman ◽

Vera Tesic ◽

Kyle Parker ◽

...

Keyword(s):

Clinical Performance ◽

Reference Sample ◽

Rapid Test ◽

Antibody Test ◽

Cross Reactivity ◽

Antibody Detection ◽

Antibody Assay ◽

Widespread Application ◽

Global Pandemic ◽

Polymerase Chain

Abstract Objectives To evaluate the analytical and clinical performance of the Truvian Easy Check coronavirus disease 2019 (COVID-19) IgM/IgG anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody test. Serologic assays have become increasingly available for surveillance through the Food and Drug Administration emergency use authorization in the ongoing COVID-19 global pandemic. However, widespread application of serologic assays has been curbed by reports of faulty or inaccurate tests. Therefore, rapid COVID-19 antibody tests need to be thoroughly validated prior to their implementation. Methods The Easy Check device was analytically evaluated and its performance was compared with the Roche Elecsys anti-SARS-CoV-2 antibody assay. The test was further characterized for cross-reactivity using sera obtained from patients infected by other viruses. Clinical performance was analyzed with polymerase chain reaction-confirmed samples and a 2015 prepandemic reference sample set. Results The Easy Check device showed excellent analytical performance and compares well with the Roche Elecsys antibody assay, with an overall concordance of 98.6%. Clinical performance showed a sensitivity of 96.6%, a specificity of 98.2%, and an overall accuracy of 98.1%. Conclusions The Easy Check device is a simple, reliable, and rapid test for detection of SARS-CoV-2 seropositivity, and its performance compares favorably against the automated Roche Elecsys antibody assay.

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Nasopharyngeal Panbio COVID-19 antigen performed at point-of-care has a high sensitivity in symptomatic and asymptomatic patients with higher risk for transmission and older age

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab059 ◽

2021 ◽

Author(s):

Mar Masiá ◽

Marta Fernández-González ◽

Manuel Sánchez ◽

Mar Carvajal ◽

José Alberto García ◽

...

Keyword(s):

Test Performance ◽

Point Of Care ◽

Rapid Test ◽

High Sensitivity ◽

Older Age ◽

Antigen Test ◽

Rt Pcr ◽

Asymptomatic Patients ◽

Clinical Scenarios ◽

Nasal Swabs

Abstract Background Performance of point-of-care tests in different clinical scenarios and on different samples remains undetermined. We comprehensively evaluated the performance of the nasopharyngeal Panbio COVID-19 antigen Rapid-Test-Device. Method Prospective study including consecutive patients attending three primary care centers (PCC) and an emergency department. The antigen test was performed at point-of-care in nasopharyngeal and nasal swabs, and in saliva. Positive and negative percent agreement (PPA, NPA) were calculated with the RT-PCR assay as reference standard. Results Of 913 patients included, 296 (32.3%) were asymptomatic and 690 (75.6%) came from the PCC. Nasopharyngeal swabs were collected from 913, nasal swabs from 659, and saliva from 611 patients. RT-PCR was positive in 196 (21.5%) nasopharyngeal samples (NPS). Overall PPA (95% CI) in NPS was 60.5% (53.3-67.4), and it was lower in nasal swabs (44.7%) and saliva (23.1%). Test performance in NPS was largely dependent on the cycle threshold (Ct) in RT-PCR, with PPA of 94% for Ct≤25 and 80% for Ct<30. In symptomatic patients, the PPA was 95% for Ct≤25; 85% for Ct<30, and 89% for the symptom triad of fever, cough and malaise. Performance was also dependent on age, with PPA of 100% in symptomatic patients >50 years with Ct<25. In asymptomatic patients, the PPA was 86% for Ct<25. In all cases, NPA was 100%. Conclusion The nasopharyngeal Panbio COVID-19 antigen test performed at point-of-care has a good sensitivity in symptomatic patients with Ct<30 and older age. The test was useful to identify asymptomatic patients with lower Ct values.

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Utility of lateral flow tests in SARS-CoV-2 infection monitorization

Revista Española de Quimioterapia ◽

10.37201/req/052.2020 ◽

2020 ◽

Vol 33 (4) ◽

pp. 258-266 ◽

Cited By ~ 3

Author(s):

Francisco Javier Candel González ◽

José Manuel Viñuela-Prieto ◽

Juan González del Castillo ◽

Pablo Barreiro García ◽

Marcos Fragiel Saavedra ◽

...

Keyword(s):

Point Of Care ◽

Rapid Test ◽

Antibody Test ◽

Field Hospital ◽

The Mean ◽

Asymptomatic Infections ◽

Severity Of The Disease ◽

Lateral Flow Tests ◽

Mean Time ◽

Serology Testing

Introduction. The diagnosis of SARS-CoV-2 infection is crucial for medical and public health reasons, to allow the best treatment of cases and the best control of the pandemic. Serology testing allows for the detection of asymptomatic infections and 19-COVID cases once the virus has been cleared. We analyzed the usefulness of the SARS-CoV-2 rapid test of Autobio and tried to correlate its pattern with the severity of COVID19 infection. Material and methods. We analyzed the accuracy and clinical usefulness of a point-of-care IgM and/or IgG test for SARS-CoV-2 in 35 COVID-19 patients [12 (34.3%) mild-moderate and 23 (65.7%) severe-critical] admitted to a field hospital in Madrid, as well as in 5 controls. Results. The mean time from the first day of symptoms to the antibody test was 28 days (SD: 8.7), similar according to the severity of the disease. All patients with SARS-CoV-2 PCR+ showed the corresponding IgG positivity, while these results were negative in all control individuals. A total of 26 (74%) cases also presented with positive IgM, 19 (83%) were severe-critical cases and 7 (58%) were mild-moderate cases. The IgM response lasted longer in the severe critical cases (mean: 29.7 days; SD: 8.4) compared to the moderate cases (mean: 21.2 days; SD: 2.0). Conclusions. Rapid serology tests are useful for the diagnosis of patients with COVID-19 (mainly IgG detection) and may also be correlated with the severity of the infection (based on IgM detection).

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Clinical Test Performance of a Rapid Point-of-Care Syphilis Treponemal Antibody Test: A Systematic Review and Meta-analysis

Clinical Infectious Diseases ◽

10.1093/cid/ciaa350 ◽

2020 ◽

Vol 71 (Supplement_1) ◽

pp. S52-S57

Author(s):

Claire C Bristow ◽

Jeffrey D Klausner ◽

Anthony Tran

Keyword(s):

Systematic Review ◽

Sensitivity And Specificity ◽

Test Performance ◽

Clinical Laboratory ◽

Point Of Care ◽

Meta Analysis ◽

Treponema Pallidum ◽

Antibody Test ◽

Health Check ◽

Clinical Test

Abstract We reviewed relevant syphilis diagnostic literature and conducted a meta-analysis to address the question, “What is the sensitivity and specificity of the Syphilis Health Check, a rapid qualitative test for the detection of human antibodies to Treponema pallidum.” The Syphilis Health Check is the only rapid syphilis test currently cleared by the Food and Drug Administration (FDA). We conducted a systematic review and a meta-analysis using Bayesian bivariate random-effects and fixed-effect models to create pooled estimates of sensitivity and specificity of the Syphilis Health Check. We identified 5 test evaluations published in the literature and 10 studies submitted to the FDA and for a Clinical Laboratory Improvement Amendments waiver application. The pooled sensitivity (95% CI) from the laboratory evaluations (n = 5) was 98.5% (92.1–100%), while pooled specificity was 95.9% (81.5–100.0%). The pooled sensitivity for prospective studies (n = 10) was 87.7% ( 71.8–97.2%), while pooled specificity was 96.7% (91.9–99.2%). Using nontreponemal supplemental testing, the sensitivity improved to a pooled sensitivity of 97.0% (94.8–98.6%). The Syphilis Health Check may provide accurate detection of treponemal antibody.

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Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population

Scientific Reports ◽

10.1038/s41598-021-85247-w ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

S. J. C. Pallett ◽

S. J. Denny ◽

A. Patel ◽

E. Charani ◽

N. Mughal ◽

...

Keyword(s):

Point Of Care ◽

Rapid Test ◽

Antibody Test ◽

Late Complications ◽

Case Definition ◽

Case Finding ◽

Infectious Period ◽

Serological Tests ◽

Specific Patient ◽

Infection Period

AbstractSevere Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Case identification is currently made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but independent validation is urgently required to assess their utility. We evaluated five different point-of-care (POC) SARS-CoV-2 antibody test kits against PCR, finding concordance across the assays (n = 15). We subsequently tested 200 patients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette and find a sensitivity of 74% in the early infection period (day 5–9 post symptom onset), with 100% sensitivity not seen until day 13, demonstrating inferiority to PCR testing in the infectious period. Negative rate was 96%, but in validating the serological tests uncovered potential false-negatives from PCR testing late-presenting cases. A positive predictive value (PPV) of 37% in the general population precludes any use for general screening. Where a case definition is applied however, the PPV is substantially improved (95.4%), supporting use of serology testing in carefully targeted, high-risk populations. Larger studies in specific patient cohorts, including those with mild infection are urgently required to inform on the applicability of POC serological assays to help control the spread of SARS-CoV-2 and improve case finding of patients that may experience late complications.

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