Sample requirements and Target population

Sample Requirements

The type of specimen(s) required:

nasopharyngeal, nasal, oropharyngeal swab, lower respiratory specimen

i. Use only synthetic fiber (Dacron or flocked) swabs with plastic shafts. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit PCR testing. Place swabs immediately into sterile tubes containing 3 ml of viral transport media. For initial testing, collecting nasopharyngeal swab specimens are preferred (refer to FDA).

ii. Transfer in 4 ºC condition and deep freeze at -70 ºC if it takes longer than 48 hours

Specimen TypeNasopharyngeal Swab or Oropharyngeal swab collected according to standard technique and immediately placed in 1-3 mL of transport media.
Minimum Sample Volume0.3 mL (300 μL)
Transport and StorageSamples should be processed and tested with the BioFire COVID-19 Test as soon as possible.
If storage is required, samples can be held:
•At room temperature for up to 4 hours (15-25ºC)
•Refrigerated for up to 2 days (2-8ºC)
•Frozen (≤-15ºC or ≤-70ºC) for up to 30 days

Refer to: InterimGuidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html

Refer to Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html

The target population

PUI(Person under investigation);

patients who meet CDC COVID-19 clinical criteria (e.g., signs and symptoms associated COVID-19 infection) in conjunction with CDC COVID-19 epidemiological criteria (e.g., history of residence in or travel to a geographic region with active COVID-19 transmission at the time of travel, or other epidemiologic criteria for which COVID-19 testing may be indicated)

The COVID-19 RNA is generally detectable during the acute phase of infection. Positive results are indicative of the presence of COVID-19 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease.

Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude COVID-19 infection and should not be used as the sole basis for patient treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.