Clinical evaluation of an immunochromatographic IgM/IgG antibody assay and chest computed tomography for the diagnosis of COVID-19

Imai, K.; Tabata, Sakiko; Ikeda, Mayu; Noguchi, Sakiko; Kitagawa, Yutaro; Matsuoka, Makoto; Miyoshi, Kazuyasu; Tarumoto, Norihito; Sakai, Jun; Ito, Tsuyoshi; Maesaki, Shigefumi; Tamura, Kouichi; Maeda, Takeshi

doi:10.1101/2020.04.22.20075564

“…Another disadvantage of the RT-PCR test is that it takes some time before results are available (25)(26)(27)(28), with estimated testing times ranging from 50 minutes to 4 hours for semiautomated to fully automated, walk-away assays and 6-14 hours for manually performed assays (29). Finally, although rapid point-of-care immunodiagnostic tests are being developed and investigated, their use for patient care is currently not recommended (25)(26)(27)(28).…”

Section: Teaching Pointsmentioning

confidence: 99%

Chest CT in COVID-19: What the Radiologist Needs to Know

Kwee

¹

,

Kwee

²

2020

View full text Add to dashboard Cite

Chest CT has a potential role in the diagnosis, detection of complications, and prognostication of coronavirus disease 2019 (COVID-19). Implementation of appropriate precautionary safety measures, chest CT protocol optimization, and a standardized reporting system based on the pulmonary findings in this disease will enhance the clinical utility of chest CT. However, chest CT examinations may lead to both false-negative and false-positive results. Furthermore, the added value of chest CT in diagnostic decision making is dependent on several dynamic variables, most notably available resources (real-time reverse transcription-polymerase chain reaction [RT-PCR] tests, personal protective equipment, CT scanners, hospital and radiology personnel availability, and isolation room capacity) and the prevalence of both COVID-19 and other diseases with overlapping manifestations at chest CT. Chest CT is valuable to detect both alternative diagnoses and complications of COVID-19 (acute respiratory distress syndrome, pulmonary embolism, and heart failure), while its role for prognostication requires further investigation. The authors describe imaging and managing care of patients with COVID-19, with topics including (a) chest CT protocol, (b) chest CT findings of COVID-19 and its complications, (c) the diagnostic accuracy of chest CT and its role in diagnostic decision making and prognostication, and (d) reporting and communicating chest CT findings. The authors also review other specific topics, including the pathophysiology and clinical manifestations of COVID-19, the World Health Organization case definition, the value of performing RT-PCR tests, and the radiology department and personnel impact related to performing chest CT in COVID-19. ©

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

“…Studies have been demonstrated that the timing of sampling re lects in the sensitivity and speci icity of serological tests. Imai, et al [15] show that the sensitivity of IC assay was low during the early phase in symptomatic and asymptomatic patients. Cassaniti, et al [16] reported that the VivaDiag ® COVID-19 IgM/IgG Rapid Test present a weak positive serology in acute patients.…”

Section: Resultsmentioning

confidence: 99%

Can the Wondfo® SARS-CoV-2 IgM/IgG antibodies be used as a rapid diagnostic test?

Pinto¹,

Brito²,

Valadão³

et al. 2020

Arch Biotechnol Biomed

3

0

View full text Add to dashboard Cite

Background: An outbreak of novel coronavirus (SARS-CoV-2) disease (COVID-19) has rapidly spread worldwide. The aim of this study was to evaluate and validate the performance of the Wondfo® lateral-flow immunochromatographic assay that detect SARS-CoV-2- IgG, IgM antibodies (Wondfo® IC), using the results obtained by the fluorescence immunoassay test as reference diagnostic. Material and methods: 97 serum specimens collected and analyzed by four independent laboratories of Sergipe/Brazil was used for validated the Wondfo® SARS-CoV-2 IgM/IgG antibodies test. The COVID-19 positive serum specimens were determined by fluorescence immunoassay technique, used as reference standard. Results: An overall of 97 serum specimens show 39 (39/97) SARS-CoV-2 IgG positive specimens, 33 (33/97) SARS-CoV-2 IgM positive specimen and 25 non-reagent specimens (25/97). However, the Wondfo® IC assay detected only 9 (9/97) IgM/IgG positive specimen and 25 (25/97) no-reagent specimen. A weak correlation was found between the outcomes of the Wondfo® IC assay and fluorescence test. The accuracy between the two tests was 32.08%. The sensitivity, specificity, positive predictive value, and negative predictive value of Wondfo® IC assay were of 11.12%, 100%, 100% and 25.27%, respectively. Moreover, no false positive sample was determinate, whereas 88.89% of false negative results were found. Conclusion: The Wondfo® IC test failed in providing a quick, valid, and reliable results and appears not to be a good alternative for clinical use in detecting pandemic coronavirus. However, if the limitations of the rapid test are known, some correction factors can be used in order to adjust the epidemiological data.

show abstract

Clinical evaluation of an immunochromatographic IgM/IgG antibody assay and chest computed tomography for the diagnosis of COVID-19

Abstract: 2 3

Cited by 31 publications

References 23 publications

Chest CT in COVID-19: What the Radiologist Needs to Know

Chest CT in COVID-19: What the Radiologist Needs to Know

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

Can the Wondfo® SARS-CoV-2 IgM/IgG antibodies be used as a rapid diagnostic test?

Contact Info

Product

Resources

About