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Test Code LAB4297 SARS COVID ANTIGEN, RAPID 

Important Note

Test is not intentended for use on inpatients suspected of COVID. Use should be limited to employees and emergencies. For inpatient testing see SARS-CoV-2 PCR

 

Specimen Type

Must use swab from QuickVue SARS Antigen Kit, no alternate specimens. 

1. Prior to collecting nasal swab, the patient will blow their nose

2 .Insert the entire absorbent tip of the swab inside a nostril (usually ½ to ¾ inch deep)

3. Firmly sample by rotating the swab in a circular path against the nasal wall at least 4 times for approximately 15 seconds

4. Repeat step 3 in the other nostril Note: Be sure to collect any nasal drainage that may be present on the swab.

5. Place the swab in a clean transport tube 6 Label tube with specimen label

Turnaround Time

Routine: 1 hour

Test Schedule

Daily

Sample Stability

Room Temp: 5 days

Method

QuickVue SARS Antigen Kit

Reference Ranges

Expected result: Negative

Synonyms

Covid-19, Covid, Corona Virus, Covid Antigen

CPT Codes

87811

Limitations

Limitations :

  • The test is intended for direct swab specimens only. Viral Transport Media (VTM) should not be used with this test as it may cause false results.
  • The contents of this kit are to be used only for the qualitative detection of SARS antigens from anterior nares nasal swab specimens.
  • A negative test result may occur if the level of antigen in a sample is below the detection limit of the test or if the sample was collected improperly. 
  • This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2. Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample. 
  • Failure to follow the Test Procedure and Interpretation of Results may adversely affect test performance and/or invalidate the Test Results. 
  • Test Results must be evaluated in conjunction with other clinical data available to the physician. 
  • Negative test results are not intended to rule in other non-SARS viral or bacterial infections. 
  • Positive test results do not rule out co-infections with other pathogens. 
  • Negative results should be treated as presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed. 
  • If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is required. 
  • The performance of this test was established based on the evaluation of a limited number of clinical specimens. Clinical performance has not been established with all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time. The performance of this test has not yet been clinically validated for use in patients without signs and symptoms of respiratory infection, or for serial screening applications and performance may differ in these populations