Evaluation of a COVID-19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS-CoV-2

Hoffman, Tove; Nissen, Karolina; Krambrich, Janina; Rönnberg, Bengt; Akaberi, Dario; Esmaeilzadeh, M; Salaneck, Erik; Lindahl, Johanna F.; Lundkvist, Åke

doi:10.1080/20008686.2020.1754538

“…On the other hand, the sensitivity of the tested LFIA showed high variability between manufacturers compared to either RT-PCR or ELISA, although their speci city seems to be high upon testing serum obtained from healthy subjects. Importantly, very low sensitivity and higher variability were seen during early time points post symptoms onset as expected, consistent with the often delayed seroconversion in COVID-19 patients which could be delayed to day 11 to day 19 post symptoms onset (Hoffman et al, 2020). Similarly, we observed that antibody responses could peak around this time range, in which our ELISA results detected the initial increase of antibodies post day 7 of symptoms onset and peaking at day 11.…”

Section: Discussionsupporting

confidence: 87%

Performance of Commercially Available Rapid Serological Assays for The Detection of SARS-CoV-2 Antibodies

Hashem¹,

Alhabbab

²

,

Algaissi

³

et al. 2020

Preprint

0

View full text Add to dashboard Cite

Abstract Background: The Coronavirus Disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several commercial SARS-CoV-2 rapid serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2 specific antibodies in COVID-19 patient samples. Method: We have evaluated the performance of seven commercially available rapid lateral flow immunoassay (LFIA) serological assays obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2 specific IgG and IgM antibodies in COVID-19 patients. Results: While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays in which it ranged from 0 to 54% for samples collected early during infection (3-7 days post symptoms onset) and from 54 to 88% for samples collected at later time points during infection (8-27 days post symptoms onset). Conclusion: Commercially available LFIA assays for detection of SARS-CoV-2 specific antibodies may be specific and show high degree of variation in their sensitivity. Further evaluations and validation of rapid serological assays is needed before being routinely used in detecting IgM and IgG in COVID-19 patients.

show abstract

“…In total, 4696 records based on screening of titles or abstracts and 235 after full text review were excluded. Forty studies totalling 73 study arms15161718192021222324252627282930313233343536373839404142434445464748495051525354 met the inclusion criteria. Table 1 summarises the studies by test method; the sum of the number of studies exceeds 40 because some evaluated more than one method.…”

Section: Resultsmentioning

confidence: 99%

“…Table 1 summarises the studies by test method; the sum of the number of studies exceeds 40 because some evaluated more than one method. Seventy per cent (28/40) of the studies were from China,16171819202122232425262728293031323334353839404145464748 8% (3/40) from Italy,153643 and the remainder from the United States (3/40),425052 Denmark (1/40),51 Spain (1/40),37 Sweden (1/40),53 Japan (1/40),44 the United Kingdom (1/40),49 and Germany (1/40) 5433…”

Section: Resultsmentioning

confidence: 99%

Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

Bastos

¹

,

Tavaziva

²

,

Abidi

³

et al. 2020

BMJ

View full text Add to dashboard Cite

AbstractObjectiveTo determine the diagnostic accuracy of serological tests for coronavirus disease-2019 (covid-19).DesignSystematic review and meta-analysis.Data sourcesMedline, bioRxiv, and medRxiv from 1 January to 30 April 2020, using subject headings or subheadings combined with text words for the concepts of covid-19 and serological tests for covid-19.Eligibility criteria and data analysisEligible studies measured sensitivity or specificity, or both of a covid-19 serological test compared with a reference standard of viral culture or reverse transcriptase polymerase chain reaction. Studies were excluded with fewer than five participants or samples. Risk of bias was assessed using quality assessment of diagnostic accuracy studies 2 (QUADAS-2). Pooled sensitivity and specificity were estimated using random effects bivariate meta-analyses.Main outcome measuresThe primary outcome was overall sensitivity and specificity, stratified by method of serological testing (enzyme linked immunosorbent assays (ELISAs), lateral flow immunoassays (LFIAs), or chemiluminescent immunoassays (CLIAs)) and immunoglobulin class (IgG, IgM, or both). Secondary outcomes were stratum specific sensitivity and specificity within subgroups defined by study or participant characteristics, including time since symptom onset.Results5016 references were identified and 40 studies included. 49 risk of bias assessments were carried out (one for each population and method evaluated). High risk of patient selection bias was found in 98% (48/49) of assessments and high or unclear risk of bias from performance or interpretation of the serological test in 73% (36/49). Only 10% (4/40) of studies included outpatients. Only two studies evaluated tests at the point of care. For each method of testing, pooled sensitivity and specificity were not associated with the immunoglobulin class measured. The pooled sensitivity of ELISAs measuring IgG or IgM was 84.3% (95% confidence interval 75.6% to 90.9%), of LFIAs was 66.0% (49.3% to 79.3%), and of CLIAs was 97.8% (46.2% to 100%). In all analyses, pooled sensitivity was lower for LFIAs, the potential point-of-care method. Pooled specificities ranged from 96.6% to 99.7%. Of the samples used for estimating specificity, 83% (10 465/12 547) were from populations tested before the epidemic or not suspected of having covid-19. Among LFIAs, pooled sensitivity of commercial kits (65.0%, 49.0% to 78.2%) was lower than that of non-commercial tests (88.2%, 83.6% to 91.3%). Heterogeneity was seen in all analyses. Sensitivity was higher at least three weeks after symptom onset (ranging from 69.9% to 98.9%) compared with within the first week (from 13.4% to 50.3%).ConclusionHigher quality clinical studies assessing the diagnostic accuracy of serological tests for covid-19 are urgently needed. Currently, available evidence does not support the continued use of existing point-of-care serological tests.Study registrationPROSPERO CRD42020179452.

show abstract

“…That means when the viral charge is high IgG/IgM tests reach high sensitivities and specificities. But 35 in that cases the disease is in advanced levels (Guo et al, 2020a;Hoffman et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

Heg.IA: An intelligent system to support diagnosis of Covid-19 based on blood tests

Barbosa¹,

Gomes

²

,

Santana

³

et al. 2020

Preprint

View full text Add to dashboard Cite

A new kind of coronavirus, the SARS-Cov2, started the biggest pandemic of the century. It has already killed more than 250,000 people. Because of this, it is necessary quick and precise diagnosis test. The current gold standard is the RT-PCR with DNA sequencing and identification, but its results takes too long to be available. Tests base on IgM/IgG antibodies have been used, but their sensitivity and specificity may be very low. Many studies have been demonstrating the Covid-19 impact in hematological parameters. This work proposes an intelligent system to support Covid-19 diagnosis based on blood testing. We tested several machine learning methods, and we achieved high classification performance: 95.159% ± 0.693 of overall accuracy, kappa index of 0.903 ± 0.014, sensitivity of 0.968 ± 0.007, precision of 0.938 ± 0.010 and specificity of 0.936 ± 0.011. These results were achieved using classical and low computational cost classifiers, with Bayes Network being the best of them. In addition, only 24 blood tests were needed. This points to the possibility of a new rapid test with low cost. The desktop version of the system is fully functional and available for free use. *

show abstract

Evaluation of a COVID-19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS-CoV-2

Cited by 172 publications

References 21 publications

Performance of Commercially Available Rapid Serological Assays for The Detection of SARS-CoV-2 Antibodies

Performance of Commercially Available Rapid Serological Assays for The Detection of SARS-CoV-2 Antibodies

Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

Heg.IA: An intelligent system to support diagnosis of Covid-19 based on blood tests

Contact Info

Product

Resources

About