Indication
This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Screening
An acute infection of the respiratory tract that is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Based on currently available information, SARS-CoV-2 is thought to mainly spread from person to person through respiratory droplets. Typically, there is a two- to 14-day incubation period and infected persons can present with no symptoms or mild to severe fever, dry cough, fatigue, and difficulty breathing. Dysgeusia, anosmia, and gastrointestinal and flu-like symptoms have also been reported. Older adults and persons of any age who have serious underlying medical conditions may be of higher risk for severe illness, including secondary infections, respiratory failure, and multi-organ dysfunction. [from NCI]
The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Sensitivity: 268 samples were collected over the course of time from 223 European patients. The group included patients hospitalized with moderate symptoms, patients admitted to the ICU with severe symptoms, and patients not hospitalized without or with mild symptoms. with SARS-CoV-2 was confirmed by RT-PCR test at the time of the diagnosis. Samples were tested at the time of admission and thereafter up to 30 days. Results are shown as days from diagnosis (percent samples tested; 95% CI - Positive Percent Agreement with PCR Comparator): ≤ 7 days (64.8%; 55.3% - 73.2%), 8-14 days (91.5%; 80.1% - 96.6%), 15 – 30 days (94.0%; 88.1% - 97.1%). Negative percent agreement (NPA): 2473 presumed SARS-CoV-2 negative samples collected before the COVID-19 outbreak from a European laboratory routine (n=1072), a US laboratory routine (n=400) and European blood donors (n= 1001) were tested resulting in an NPA of 99.3% (2455 / 2473, 95% CI: 98.9% – 99.5%).
Citations
Not provided
Not provided
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