Evaluation of performance of two SARS-CoV-2 Rapid whole-blood finger-stick IgM-IgG Combined Antibody Tests

AbstractBackgroundThe SARS-CoV-2 virus is responsible for the infectious respiratory disease called COVID-19 (COronaVIrus Disease). In response to the growing COVID-19 pandemic, Rapid Diagnostic Tests (RDTs) have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. We conducted a real-life study to evaluate the performance of two RDTs, COVID-PRESTO® and COVID-DUO®, compared to the gold standard, RT-PCR.MethodsRT-PCR testing of SARS-Cov-2 was performed from nasopharyngeal swab specimens collected in adult patients visiting the infectious disease department at the hospital (Orléans, France). Fingertip whole blood samples taken at different time points after onset of the disease were tested with RDTs. The specificity and sensitivity of the rapid test kits compared to test of reference (RT-PCR) were calculated.ResultsAmong 381 patients with symptoms of COVID-19 who went to the hospital for a diagnostic, 143 patients were RT-PCR negative. Results of test with RDTs were all negative for these patients, indicating a specificity of 100% for both RDTs.In the RT-PCR positive subgroup (n=238), 133 patients were tested with COVID-PRESTO® and 129 patients were tested with COVID-DUO® (24 patients tested with both). The further the onset of symptoms was from the date of collection, the greater the sensitivity. The sensitivity of COVID-PRESTO® test ranged from 10.00% for patients having experienced their 1st symptoms from 0 to 5 days ago to 100% in patients where symptoms had occurred more than 15 days before the date of tests. For COVID-DUO® test, the sensitivity ranged from 35.71% [0-5 days] to 100% (> 15 days).ConclusionCOVID-PRESTO® and DUO® RDTs turned out to be very specific (none false positive) and to be sensitive enough after 15 days from onset of symptom. These easy to use IgG/IgM combined test kits are the first ones allowing a screening with capillary blood sample, by typing from a finger prick. These rapid tests are particularly interesting for screening in low resource settings.

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“Evaluation of a COVID-19 IgM and IgG Rapid Test and Assessment of Specific Antibody Response in COVID-19 patients, Tunisia 2020”

10.21203/rs.3.rs-237568/v1 ◽

2021 ◽

Author(s):

letaief hejer ◽

Sonia Dhaouadi ◽

Aicha Hechaichi ◽

Mouna Safer ◽

Chahida Harizi ◽

...

Keyword(s):

Antibody Response ◽

Clinical Performance ◽

Rapid Test ◽

Antibody Test ◽

Antibody Responses ◽

Rt Pcr ◽

Serological Tests ◽

Clinical Sensitivity ◽

Negative Results ◽

Finger Stick

Abstract Background COVID-19 pandemic is a massive global health emergency. Although RT-PCR is the gold standard for diagnosing suspected cases, there is a need of serological tests to investigate antibody responses. Many serologic immunoassays have been developed to detect antibodies to SARS-CoV2, including rapid tests. This study assessed the clinical performance of the SARS-CoV-2 antibody test (colloidal gold immunochromatography, LEPU TECHNOLOGY) and evaluated the kinetic antibody response in COVID-19 patients.Methods: Samples collected by finger stick; obtained from RT-PCR confirmed cases and samples of negative controls were tested with the IgM/IgG Detection Kit . Results: The kit shows a clinical sensitivity of 65.7 % [59.7%-71.3%] and a specificity of 96.3% [93.0%-98.3%]. The predictive positive value and negative predictive value were respectively 95.2% [91.0%-97.8%] and 71.4% [66.1%-76.2%]. The seroconversion of specific IgM and IgG antibodies were observed as early as the 2nd day after symptom onset.Conclusions: This test is quite useful for assessing previous virus exposure, although negative results may be unreliable during the first weeks after infection. Longitudinal studies on antibody responses during and post infection are needed.

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High performances of a novel antigen detection test on nasopharyngeal specimens for SARS-CoV-2 infection diagnosis: a prospective study

10.1101/2020.10.28.20220657 ◽

2020 ◽

Author(s):

Laura Courtellemont ◽

jerome Guinard ◽

Clemence Guillaume ◽

Susanna Giache ◽

Vincent Rzepecki ◽

...

Keyword(s):

Prospective Study ◽

Large Scale ◽

Quantitative Polymerase Chain Reaction ◽

Real Life ◽

Rapid Test ◽

Threshold Value ◽

Public Health Issue ◽

Nasopharyngeal Swab ◽

Specificity And Sensitivity ◽

Asymptomatic Patients

Introduction The SARS-CoV-2 pandemic has become a major public health issue worldwide. Developing and evaluating rapid and easy-to-perform diagnostic tests is an absolute priority. The current prospective study was designed to assess diagnostic performances of an antigen-based rapid detection test (COVID-VIRO) in a real-life setting. Methods Two nasopharyngeal specimens of symptomatic or asymptomatic adult patients hospitalized in the Infectious Diseases Department or voluntarily accessing the COVID-19 Screening Department of the Regional Hospital of Orleans, France, were concurrently collected. COVID VIRO diagnostic specificity and sensitivity were assessed in comparison to real-time reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) results. A subgroup of patients underwent an additional oropharyngeal and/or a saliva swab for rapid testing. Results 121 patients already having a confirmed infection and 127 patients having no evidence of recent or ongoing infection were enrolled, for a total of 248 couple of nasopharyngeal swab specimens. Overall COVID-VIRO sensitivity was 96.7% (IC: 93.5%-99.9%). In asymptomatic patients, patients having symptoms for more than 4 days and those having a RT-qPCR Cycle threshold value >32, sensitivity was of 100%, 95.8% and 96.9% respectively. The concordance between RT-qPCR and COVID VIRO rapid test was 100% for the 127 patients with no SARS-CoV-2 infection. Conclusion COVID-VIRO test had 100% specificity and above 95% sensitivity, better than WHO recommendations (specificity ≥97-100%, sensitivity ≥80%). These rapid tests are particularly interesting for large-scale screening in Emergency Department, low resource settings and airports.

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Evaluation of the practicability of a finger-stick whole-blood SARS-Cov-2 self-test adapted for the general population

PLoS ONE ◽

10.1371/journal.pone.0245848 ◽

2021 ◽

Vol 16 (1) ◽

pp. e0245848

Author(s):

Thierry Prazuck ◽

Jean Phan Van ◽

Florence Sinturel ◽

Frederique Levray ◽

Allan Elie ◽

...

Keyword(s):

General Population ◽

Whole Blood ◽

Point Of Care ◽

Real Life ◽

High Sensitivity ◽

University Hospital ◽

Life Study ◽

Self Test ◽

Finger Stick ◽

Instructions For Use

Background COVID-19 (COronaVIrus Disease 2019) is an infectious respiratory disease caused by the novel SARS-CoV-2 virus. Point of Care (POC) tests have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. They need to be easily usable by the general population in order to alleviate the lockdown that many countries have initiated in response to the growing COVID-19 pandemic. A real-life study has been conducted in order to evaluate the performance of the COVID-PRESTO® POC test and the results were recently published. Even if this test showed very high sensitivity and specificity in a laboratory setting when used by trained professionals, it needs to be further evaluated for practicability when used by the general public in order to be approved by health authorities for in-home use. Methods 143 participants were recruited between March 2020 and April 2020 among non-medical populations in central France (nuclear plant workers, individuals attending the Orleans University Hospital vaccination clinic and Orleans University Hospital non-medical staff). Instructions for use, with or without a tutorial video, were made available to the volunteers. Two separate objectives were pursued: evaluation of the capability of participants to obtain an interpretable result, and evaluation of the users’ ability to read the results. Results 88.4% of the test users judged the instructions for use leaflet to be clear and understandable. 99.3% of the users obtained a valid result and, according to the supervisors, 92.7% of the tests were properly performed by the users. Overall, 95% of the users gave positive feedback on the COVID PRESTO® as a potential self-test. Neither age nor education had an influence. Conclusion COVID-PRESTO® was successfully used by an overwhelming majority of participants and its use was judged very satisfactory, therefore showing promising potential as a self-test to be used by the general population. This POC test can become an easy-to-use tool to help detect whether individuals are protected or not, particularly in the context of a second wave or a mass vaccination program.

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Evaluation of the Practicability of a Finger-Stick Whole-Blood SARS-Cov-2 Self-Test Adapted for the General Population.

10.1101/2020.07.13.20152660 ◽

2020 ◽

Author(s):

thierry prazuck ◽

Jean Phan Van ◽

Florence sinturel ◽

frederique levray ◽

Allan Elie ◽

...

Keyword(s):

General Population ◽

Whole Blood ◽

Real Life ◽

High Sensitivity ◽

University Hospital ◽

Life Study ◽

Health Authorities ◽

Self Test ◽

Finger Stick ◽

Instructions For Use

Background COVID-19 (COronaVIrus Disease 2019) is an infectious respiratory disease caused by the novel SARS-CoV-2 virus. Rapid Diagnostic Tests (RDTs) have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood and easily usable by the general population are needed in order to alleviate the lockdown that many countries have initiated in response to the growing COVID-19 pandemic. A real-life study has been conducted in order to evaluate the performance of the COVID-PRESTO RDT and the results have been submitted for publication and are currently under review. Even if this test showed very high sensitivity and specificity in a laboratory setting when used by trained professionals, it needs to be further evaluated for practicability when used by common folk in order to be approved by health authorities for in-home use Methods 142 participants were recruited between March 2020 and April 2020 among non-medical populations in central France (nuclear plants workers, individuals attending the Orleans University Hospital vaccination clinic and Orleans University Hospital non-medical staff). Instructions for use with or without a tutorial video was made available to the volunteers. Two separate objectives were pursued: evaluation of the capability of participants to obtain an interpretable result, and evaluation of the users ability to read the results. Results 88.4 % of the test users judged the instruction for use leaflet to be clear and understandable. 99.3 % of the users obtained a valid results and according to the supervisors 92.7% of the tests were properly performed by the user. Overall, 95% of the users gave positive feedback toward the COVID PRESTO as a potential self-test. No influence of age and education was observed. Conclusion COVID-PRESTO was successfully used by an overwhelming majority of participants and its utilization was judged very satisfactory, therefore showing a promising potential as a self-test to be used by the general population. This RDT can become an easy-to-use tool to help know whether individuals are protected or not, particularly in the perspective of a second wave or a mass vaccination program.

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Validation of the Panbio™ COVID-19 Antigen Rapid Test (Abbott) to screen for SARS-CoV-2 infection in Sint Maarten: a diagnostic accuracy study

10.1101/2021.09.23.21260526 ◽

2021 ◽

Author(s):

Colin King ◽

Eva Lista-de Weever ◽

Maria Henry ◽

Radjin Steingrover ◽

Chérina Fleming ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Close Contact ◽

Rapid Test ◽

Nasopharyngeal Swab ◽

Rt Pcr ◽

The Public ◽

Negative Results ◽

Accuracy Study ◽

Antigen Tests ◽

Dutch Caribbean

AbstractObjectivesControl of the pandemic has required countries to look for other forms of tests besides the gold standard real-time polymerase chain reaction (RT-PCR). Rapid antigen tests (RAT), though less sensitive than RT-PCR, offer the possibility of rapid, inexpensive and early detection of the most infectious COVID-19 cases. Only very few studies have assessed the performance of the Abbott Panbio COVID-19 RAT among asymptomatic people or in Latin America. This study set out to validate this test among people attending the public test street in Sint Maarten, Dutch Caribbean.MethodsPeople of all ages were recruited from the public COVID-19 test street regardless of COVID-19 symptoms. They received a nasopharyngeal swab for the Abbott Panbio COVID-19 RAT and the RT-PCR Qtower. Diagnostic accuracy of the RAT was compared to the RT-PCR among the overall study population and for subgroups with/without symptoms, with/without close contact and different Ct values.ResultsUsing a RT-PCR Ct cut-off value of <33, 119 out of 1,411 people (8.4%) tested positive for SARS-CoV-2. Most were asymptomatic (59%). The overall sensitivity and specificity of the RAT was 84% (95% CI 76.2-90.1) and 99.9% (95% CI 99.6-100) respectively. The sensitivity reduced to 67.6% (95% CI: 49.5%, 82.6%) among people without symptoms, regardless of whether they were in close contact with a known COVID-19 case. Sensitivity reduced considerably with a Ct cut-off value of <35.ConclusionsThe Abbott Panbio RAT is a valid and cheaper alternative to RT-PCR when used on symptomatic individuals among the general population. However, among asymptomatic people it should not be used as a stand-alone test and negative results should be confirmed with RT-PCR.

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Scoring System for the Diagnosis of COVID-19

The Open Public Health Journal ◽

10.2174/1874944502013010413 ◽

2020 ◽

Vol 13 (1) ◽

pp. 413-414 ◽

Cited By ~ 1

Author(s):

Mohamed Farouk Allam

Keyword(s):

Scoring System ◽

Clinical Symptoms ◽

False Negative ◽

Nasopharyngeal Swab ◽

Rt Pcr ◽

Pcr Assay ◽

Negative Results ◽

False Negative Results ◽

Symptoms And Signs

Due to the international spread of COVID-19, the difficulty of collecting nasopharyngeal swab specimen from all suspected patients, the costs of RT-PCR and CT, and the false negative results of RT-PCR assay in 41% of COVID-19 patients, a scoring system is needed to classify the suspected patients in order to determine the need for follow-up, home isolation, quarantine or the conduction of further investigations. A scoring system is proposed as a diagnostic tool for suspected patients. It includes Epidemiological Evidence of Exposure, Clinical Symptoms and Signs, and Investigations (if available). This scoring system is simple, could be calculated in a few minutes, and incorporates the main possible data/findings of any patient.

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Evaluation of SARS-CoV-2 antigen-based rapid diagnostic kits in Pakistan: formulation of COVID-19 national testing strategy

Virology Journal ◽

10.1186/s12985-021-01505-3 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Umar Saeed ◽

Sara Rizwan Uppal ◽

Zahra Zahid Piracha ◽

Azhar Rasheed ◽

Zubair Aftab ◽

...

Keyword(s):

Gold Standard ◽

Injection Drug Users ◽

Drug Users ◽

Diagnostic Testing ◽

False Negative ◽

Cross Sectional Study ◽

Nasopharyngeal Swab ◽

Rt Pcr ◽

Cross Sectional ◽

Negative Results

AbstractRapid diagnosis of SARS-CoV-2 during pandemic enables timely treatment and prevention of COVID-19. Evaluating the accuracy and reliability of rapid diagnostic testing kits is crucial for surveillance and diagnosis of SARS-CoV-2 infections in general population, injection drug users, multi-transfused populations, healthcare workers, prisoners, barbers and other high risk populations. The aim of this study was to evaluate performance and effectiveness of nasopharyngeal swab (NSP) and saliva based rapid antigen detection testing kits in comparison with USFDA approved triple target gold standard real-time polymerase chain reaction. A cross-sectional study was conducted on 33,000 COVID-19 suspected patients. From RT-PCR positive patients, nasopharyngeal swab (NSP) and saliva samples were obtained for evaluation of rapid COVID-19 testing kits (RDT). 100/33,000 (0.3%) of specimens were RT-PCR positive for SARS-CoV-2. Among RT-PCR positive, 62% were males, 34% were females, and 4% were children. The NSP-RDT (Lepu Medical China) analysis revealed 53% reactivity among males, 58% reactivity among females, and 25% reactivity among children. However saliva based RDT (Lepu Medical China) analysis showed 21% reactivity among males and 23% among females, and no reactivity in children. False negative results were significantly more pronounced in saliva based RDT as compared to NSP-RDT. The sensitivity of these NSP-RDT and saliva based RDT were 52% and 21% respectively. The RDTs evaluated in this study showed limited sensitivities in comparison to gold standard RT-PCR, indicating that there is a dire need in Pakistan for development of suitable testing to improve accurate COVID-19 diagnosis in line with national demands.

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SARS-CoV-2 in peritoneal swabs from asymptomatic patients undergoing emergency abdominal surgery

Journal of Surgical Case Reports ◽

10.1093/jscr/rjab116 ◽

2021 ◽

Vol 2021 (4) ◽

Author(s):

Jasim AlAradi ◽

Rawan A Rahman AlHarmi ◽

Mariam AlKooheji ◽

Sayed Ali Almahari ◽

Mohamed Abdulla Isa ◽

...

Keyword(s):

Peritoneal Fluid ◽

Case Series ◽

Rapid Test ◽

Nasopharyngeal Swab ◽

Rt Pcr ◽

Protective Measures ◽

The Public ◽

Asymptomatic Patients ◽

Number Of Patients ◽

Viral Transfer

Abstract This is a case series of five patients with acute abdomen requiring surgery who tested positive for coronavirus disease 2019 (COVID-19) and were asymptomatic, with the purpose of detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in peritoneal fluid. Nasopharyngeal swab was done as a prerequisite for admission or prior to admission as part of random testing. Two methods of viral testing were employed: Xpert® Xpress SARS-CoV-2 (rapid test) and real-time reverse transcription polymerase chain reaction (RT-PCR). Either or both tests were done, with the former performed for patients requiring surgery immediately. Surgery was performed within 24–36 h from admission. Peritoneal fluid swabs were obtained for the detection of SARS-CoV-2 using RT-PCR test. Swabs were immediately placed in viral transfer media and delivered to the public health laboratory in an ice bag. SARS-CoV-2 was not detected in peritoneal swabs. Due to the limited number of patients, further studies are required; yet, protective measures should still be taken by surgeons when dealing with COVID-19 cases.

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Acceptability and feasibility of HIV testing in general medicine by ELISA or rapid test from finger-stick whole blood

La Presse Médicale ◽

10.1016/j.lpm.2017.11.022 ◽

2018 ◽

Vol 47 (2) ◽

pp. e15-e23 ◽

Cited By ~ 2

Author(s):

Hubert Demorat ◽

Amanda Lopes ◽

Dorothée Chopin ◽

Véronique Delcey ◽

Philippe Clevenbergh ◽

...

Keyword(s):

Hiv Testing ◽

Whole Blood ◽

General Medicine ◽

Rapid Test ◽

Finger Stick

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Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for the diagnosis of COVID-19 in primary healthcare centers

10.1101/2020.10.16.20213850 ◽

2020 ◽

Cited By ~ 5

Author(s):

Eliseo Albert ◽

Ignacio Torres ◽

Felipe Bueno ◽

Dixie Huntley ◽

Estefanía Molla ◽

...

Keyword(s):

Primary Healthcare ◽

Rapid Test ◽

Field Evaluation ◽

Antigen Test ◽

Rt Pcr ◽

Test Device ◽

Specificity And Sensitivity ◽

Primary Healthcare Centers

AbstractWe evaluated the Panbio™ COVID-19 AG Rapid Test Device (RAD) for the diagnosis of COVID-19 in symptomatic patients attended in primary healthcare centers (n=412). Overall specificity and sensitivity of RAD was 100% and 79.6%, respectively, taking RT-PCR as the reference. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results.

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