Immunological assays for SARS-CoV-2: an analysis of available commercial tests to measure antigen and antibodies

González, John Mario; Shelton, William J.; Díaz-Vallejo, Manuel; Rodriguez-Castellanos, Victoria E.; Zuluaga, Juan Diego H.; Chamorro, Diego F.; Arroyo-Ariza, Daniel

doi:10.1101/2020.04.10.20061150

Cited by 14 publications

(14 citation statements)

References 32 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…19,20 Huge knowledge gaps identified in a study highlight the immediate need for commercialized an-tigen test comparative studies. 21 A possible explanation of the variations in performance could be linked to differences in protein targets. However, only a minority of manufacturers report details regarding the detection system.…”

Section: Discussionmentioning

confidence: 99%

Sensitivity and Specificity of Lateral Flow Antigen Test Kits for COVID-19 in Asymptomatic Population of Quarantine Centre of Province 3

Shrestha

Neupane

Pant

et al. 2020

Kathmandu Univ. Med. J.

View full text Add to dashboard Cite

Background Nearly after 6 months of the spread of Corona Virus Disease 19, along with the world Nepal is still trying to control the spread and prevent general population from acquiring it. With limited resources in manpower, technology and evidence it has been a difficult battle. But with time and more understanding of the virus new technology to detect the virus are coming up. It is a major breakthrough in the diagnostic field as this helps us in not only detecting the virus but also helps us to mobilize our human resources. This comes in a time where the cases are increasing at an alarming rate. Although numbers of Polymerase Chain Reaction testing have increased but due to the time consuming and the cost wise, we need a faster and equally reliable alternative. Antigen test approved by different countries can be used for point of care, screening and surveillance depending upon the requirements after calculating its sensitivity, specificity and accuracy. Objective To find out sensitivity and specificity of the Antigen test kit for COVID-19. Method Antigen tests were compared with Reverse Transcription Polymerase Chain Reaction as a reference standard in calculated sample size of 113 subjects in a high risk population. Both Reverse Transcription Polymerase Chain Reaction and antigen test were performed in a same subject with in maximum of 2 days’ interval. Convenience sampling technique was used to select the subjects. Ethical approval was taken from Nepal Health Research Council before data collection. Study was done from August to September 2020 from Quarantine center of Province 3. Result There were total of 113 test carried out, among those 47 were positive and 66 were negative in Reverse Transcription Polymerase Chain Reaction. After preparing two by two table, Sensitivity and specificity of the tested was calculated which came out to be 85% and 100% respectively, with accuracy of 93.80%. Conclusion Even though the sensitivity and specificity came to be higher, this test should be interpreted cautiously depending upon the prevalence of Corona Virus Disease 19 in that particular community and the clinical and epidemiological context of the person who has been tested. When in doubt by clinical correlation should be confirmed with Reverse Transcription Polymerase Chain Reaction.

show abstract

Section: Discussionmentioning

confidence: 99%

Sensitivity and Specificity of Lateral Flow Antigen Test Kits for COVID-19 in Asymptomatic Population of Quarantine Centre of Province 3

Shrestha

Neupane

Pant

et al. 2020

Kathmandu Univ. Med. J.

View full text Add to dashboard Cite

show abstract

“…SARS-CoV-2 seroconversion occurs 7-14 days after the onset of symptoms (8,(14)(15)(16). Classic ELISA tests (enzyme-linked immunosorbent assays) are currently available, but considerable effort has been made by manufacturers to offer faster answers with rapid diagnostic tests (RDTs) (17). According to the Foundation for Innovative New Diagnostics (FIND), 177 SARS-on December 6, 2020 by guest http://jcm.asm.org/…”

Section: Introductionmentioning

confidence: 99%

Evaluating 10 Commercially Available SARS-CoV-2 Rapid Serological Tests by Use of the STARD (Standards for Reporting of Diagnostic Accuracy Studies) Method

et al. 2021

View full text Add to dashboard Cite

Numerous SARS-CoV-2 rapid serological tests have been developed, but their accuracy has usually been assessed using very few samples, and rigorous comparisons between these tests are scarce. In this study, we evaluated and compared 10 commercially-available SARS-CoV-2 rapid serological tests using the STARD methodology (Standards for Reporting of Diagnostic Accuracy Studies). 250 sera from 159 PCR-confirmed SARS-CoV-2 patients (collected from 0 to 32 days after onset of symptoms) were tested with rapid serological tests. Control sera (N = 254) were retrieved from pre-COVID periods from patients with other coronavirus infections (N = 11), positive rheumatoid factors (N = 3), IgG/IgM hyperglobulinemia (N = 9), malaria (n = 5), or no documented viral infection (N = 226). All samples were tested using rapid lateral flow immunoassays (LFIA) from 10 manufacturers. Only four tests achieved ≥98% specificity, with other tests ranging from 75.7%-99.2%. Sensitivities varied by the day of sample collection, from 31.7%-55.4% (Days 0-9), 65.9%-92.9% (Days 10-14), and 81.0%-95.2% (>14 days) after the onset of symptoms, respectively. Only three tests evaluated met French Health Authorities’ thresholds for SARS-CoV-2 serological tests (≥90% sensitivity + ≥98% specificity). Overall, the performances between tests varied greatly, with only a third meeting acceptable specificity and sensitivity thresholds. Knowing the analytical performance of these tests will allow clinicians and most importantly laboratorians to use them with more confidence, could help determine the general population’s immunological status, and may help to diagnose some patients with false-negative RT-PCR results.

show abstract

“…The diagnostic procedure of an acute infection is based on direct virus detection in oro- or nasopharyngeal swabs via RT-qPCR [ 8 ]. Past infections on the other hand can be assessed using SARS-CoV-2-specific serological testing such as ELISA, neutralization assays (NT), or immunofluorescence assays [ 9 , 10 ]. IgG seroconversion was reported to be very similar to that in SARS-CoV infections and occurred 7 (50% seroconversion rate) to 14 days (100% seroconversion rate) post symptom onset.…”

Section: Introductionmentioning

confidence: 99%

SARS-CoV-2 Seroprevalence among Health Care Workers—A Voluntary Screening Study in a Regional Medical Center in Southern Germany

Müller

Girl

Ruhnke

et al. 2021

IJERPH

View full text Add to dashboard Cite

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is associated with a potentially severe clinical manifestation, coronavirus disease 2019 (COVID-19), and currently poses a worldwide challenge. Health care workers (HCWs) are at the forefront of any health care system and thus especially at risk for SARS-CoV-2 infection due to their potentially frequent and close contact with patients suffering from COVID-19. Serum samples from 198 HCWs with direct patient contact of a regional medical center and several outpatient facilities were collected during the early phase of the pandemic (April 2020) and tested for SARS-CoV-2-specific antibodies. Commercially available IgA- and IgG-specific ELISAs were used as screening technique, followed by an in-house neutralization assay for confirmation. Neutralizing SARS-CoV-2-specific antibodies were detected in seven of 198 (3.5%) tested HCWs. There was no significant difference in seroprevalence between the regional medical center (3.4%) and the outpatient institution (5%). The overall seroprevalence of neutralizing SARS-CoV-2-specific antibodies in HCWs in both a large regional medical center and a small outpatient institution was low (3.5%) at the beginning of April 2020. The findings may indicate that the timely implemented preventive measures (strict hygiene protocols, personal protective equipment) were effective to protect from transmission of an airborne virus when only limited information on the pathogen was available.

show abstract

Immunological assays for SARS-CoV-2: an analysis of available commercial tests to measure antigen and antibodies

Cited by 14 publications

References 32 publications

Sensitivity and Specificity of Lateral Flow Antigen Test Kits for COVID-19 in Asymptomatic Population of Quarantine Centre of Province 3

Sensitivity and Specificity of Lateral Flow Antigen Test Kits for COVID-19 in Asymptomatic Population of Quarantine Centre of Province 3

Evaluating 10 Commercially Available SARS-CoV-2 Rapid Serological Tests by Use of the STARD (Standards for Reporting of Diagnostic Accuracy Studies) Method

SARS-CoV-2 Seroprevalence among Health Care Workers—A Voluntary Screening Study in a Regional Medical Center in Southern Germany

Contact Info

Product

Resources

About