This article is a Preprint
Preprints are preliminary research reports that have not been certified by peer review. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Preprints posted online allow authors to receive rapid feedback and the entire scientific community can appraise the work for themselves and respond appropriately. Those comments are posted alongside the preprints for anyone to read them and serve as a post publication assessment.
Assessment of a serological diagnostic kit of sars-cov-2 availble in Iran
Preprint
in English
| medRxiv
| ID: ppmedrxiv-20090209
Journal article
A scientific journal published article is available and is probably based on this preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See journal article
A scientific journal published article is available and is probably based on this preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See journal article
ABSTRACT
BackgroundThe SARS-CoV-2 epidemic broke out in December 2019 and now is characterized as a pandemic. The effective control of this infectious disease requires access to diagnostic techniques, both for case finding and epidemic size estimation. The molecular technique is routinely being used worldwide. Although it is the "standard" case detection and management method, it has its own shortcomings. Thus, some easy-to-use rapid serological tests were developed. MethodsOne hundred and fourteen positive RT-PCR-diagnosed patients were tested by VivaDiag Kit, a brand of rapid serological kits available in hospitals affiliated to Tehran University of Medical Sciences (TUMS), Tehran, Iran. Frozen serum specimens taken from healthy people in summer and autumn 2019, were also tested as negative controls. ResultsThe test sensitivity was 47.9% (95% confidence interval [CI] 38.8-56.9) for IgM and 47.0% (95% CI 38.0-56.0) for IgG. There was no difference between IgG and IgM seropositivity except in one case. Specificity was calculated as 99.0% (95% CI 96.4-99.9) for IgM and of 100.0% (95% CI 0.98.2-100.0) for IgG. Sensitivity was higher in men and older participants. ConclusionThis test can be used for epidemiological investigations especially for the estimation of the level of infection in the community, after it is properly corrected for sensitivity and specificity. The low sensitivity could be attributed to the technical limitation of the kits or low levels of antibodies after infection. The different sensitivity in age and sex groups supports the hypothesis that different people show different immune responses to this virus.
cc_by
Full text:
Available
Collection:
Preprints
Database:
medRxiv
Type of study:
Diagnostic study
/
Experimental_studies
/
Observational study
/
Rct
Language:
English
Year:
2020
Document type:
Preprint