Validity of a Serological Diagnostic Kit for SARS-CoV-2 Available in Iran.
Arch Iran Med
; 23(9): 629-632, 2020 09 01.
Article
in English
| MEDLINE | ID: covidwho-802876
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
ABSTRACT
BACKGROUND:
The Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic broke out in December 2019 and is now characterized as a pandemic. Effective control of this infectious disease requires access to diagnostic techniques, for both case finding and epidemic size estimation. The molecular technique is routinely 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 have been developed.METHODS:
One 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 fall 2019 were also tested as negative controls.RESULTS:
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.CONCLUSION:
This 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 limitations of the kit 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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
Serologic Tests
/
Coronavirus Infections
/
Clinical Laboratory Techniques
/
Betacoronavirus
/
Antibodies, Viral
Type of study:
Diagnostic study
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Adult
/
Female
/
Humans
/
Male
Country/Region as subject:
Asia
Language:
English
Journal:
Arch Iran Med
Year:
2020
Document Type:
Article
Affiliation country:
Aim.2020.75
Similar
MEDLINE
...
LILACS
LIS