Sample Requirements
The type of specimen(s) required:
nasopharyngeal, oropharyngeal, nasal swab
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
sputum, BAL (Bronchoalveolar washing), tracheal aspirate
i.Bronchoalveolar lavage, tracheal aspirate
-2 to 3 mL should be collected in a sterile, leak-proof, screw-cap sputum collection cup or sterile, dry container.
-If clinically indicated (eg, if the patient is undergoing invasive mechanical ventilation), collection and testing of a lower respiratory tract aspirate or bronchoalveolar lavage sample should be performed.
ii.Sputum
-The patient should rinse his or her mouth with water and then expectorate deep cough sputum directly into a sterile, leak-proof, screw-cap sputum collection cup or sterile, dry container.
| Specimen Type | Nasopharyngeal Swab or Oropharyngeal swab collected according to standard technique and immediately placed in 1-3 mL of transport media. |
|---|---|
| Minimum Sample Volume | 0.3 mL (300 μL) |
| Transport and Storage | Samples 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: Interim Guidelines 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
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.
Testing with the GG COVID-19 Quadplex Real-Time RT-PCR is intended for use by qualified and trained laboratory personnel specifically instructed and trained in the techniques of Real-Time RT-PCR assays. The GG COVID-19 Quadplex Real-Time RT-PCR is only for use under the Food and Drug Administration’s Emergency Use Authorization.