Indication
This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Diagnosis, 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]
Not provided
Seventy-seven (77) presumed true negative samples that had been collected prior to the onset of the emergence of COVID-19 pandemic were also randomized before sending to the clinical laboratory for testing. All one-hundred and seven (107) samples were assayed using the Tru-Immune SARS-CoV-2 Neutralizing Antibody ELISA Test and all absorbance readings at 450nm were converted to %Inhibition values based on the equation previously described. Any %Inhibition value > 20% Inhibition was reported as positive and all values < 20% were reported as negative. PCR+ samples were 100.0% positive by the Tru-Immune SARS-CoV-2 Neutralizing Antibody ELISA Test and all negative samples returned a negative result for 100% negative agreement. Results are shown in the table below:
SARS-CoV-2 PCR Status
Neutralizing Antibody ELISA Test Positive Negative Total
Positive 30 0 30
Negative 0 77 77
Total 30 77 107
Percent Positive Agreement (Sensitivity) = TP/(TP+FN) =100%
Percent Negative Agreement (Specificity) = TN/ (TN+FP)= 100%
Citations
Not provided
Establish or confirm diagnosis
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