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COVID-19 Molecular Test
TEST CODE
COVID19
CPT CODE
U0004, 87635
SPECIMEN TRANSPORT
- Specimens can be sent room temperature, refrigerated, or frozen
SPECIMEN STABILITY
SPECIMENS COLLECTED IN VTM, UTM, OR SALINE
Specimen Temperature | Thermo Fisher Platform | Hologic Platform |
---|---|---|
Room temperature | 3 days | Up to 24 hours |
Refrigerated | 1 week | 4 days |
Frozen | 1 month | 1 month |
REJECTION CRITERIA
Cotton-tip swabs in UTM/VTM; swabs with calcium alginate; swabs with wooden shafts
SPECIMEN TYPE
- Nasal swab
- Nasal mid-turbinate (NMT) swab
- Nasopharyngeal (NP) swab
- Oropharyngeal (OP) swab
Exact manufacturer of the swab and transport media may vary with supply. Any swab of appropriate size and configuration with synthetic tip can be used, EXCEPT for calcium alginate tips, and swabs with wood shafts.
TURN AROUND TIME
24 – 48 hours
COLLECTION
NASAL SWAB COLLECTION
- Partially peel open the swab package and remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip touches any surface, throw it away and use a new swab. Hold the swab by placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
- Carefully insert the swab into the patient’s first nostril until resistance is met at the level of the turbinates (less than one inch into the patient’s nostril). Rotate the swab a few times against the nasal wall for 10-15 seconds. Then remove the swab from the patient’s nostril.
- Using the same swab, repeat the same process with the patient’s other nostril.
- While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. Immediately place the swab into the transport media.
- Align the score line with the top edge of the tube and carefully break the shaft at the score line. Throw away the broken-off shaft.
- Tightly screw the cap onto the tube. Label the tube with two patient identifiers (name and date of birth).
OROPHARYNGEAL (OP) COLLECTION
Collection for throat swab specimens.
- Partially peel open the swab package and remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip touches any surface, throw it away and use a new swab. Hold the swab by placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
- Carefully insert the swab into the patient’s throat, ensuring contact with bilateral tonsils (if present) and the posterior pharyngeal wall. Then, withdraw the swab without touching the inside of the cheeks or tongue.
- While holding the swab in hand, unscrew the tube cap. Do not spill the tube contents. Immediately place the swab into the transport media.
- Align the score line with the top edge of the tube and carefully break the shaft at the score line. Throw away the broken-off shaft.
- Tightly screw the cap onto the tube. Label the tube with two patient identifiers (name and date of birth).
NASOPHARYNGEAL (NP) COLLECTION
Swab specimens should be obtained from the posterior nasopharynx. Ideally two swabs should be collected, although one is acceptable. Ask the patient if they have a deviated septum and then have them clear their nasal passages by blowing their nose.
- Tilt the patient’s head back to a 70˚ angle. Check for nasal obstructions.
- Gently insert the swab straight back into a nostril aiming posteriorly along the floor of the nasal cavity until reaching the posterior wall of the nasopharynx. Keep the swab near the septum floor of the nose while gently pushing the swab into the post nasopharynx (the swab should reach depth equal to distance from nostrils to the outer opening of the ear). Be careful not to insert the swab upwards. Do not force the swab. If there is an obstruction, try the other nostril. Leave the swab in place for up to 10 seconds to absorb secretions. Slowly remove the swab while rotating it.
- While holding the swab in hand, unscrew the tube cap. Do not spill the tube contents. Immediately place the swab into the transport media.
- Align the score line with the top edge of the tube and carefully break the shaft at the score line. Throw away the broken-off shaft.
- Tightly screw the cap onto the tube. Label the tube with two patient identifiers (name and date of birth).
TEST SETUP
Monday – Saturday (days)
METHODOLOGY
THERMO FISHER RT-PCR SARS-COV-2 ASSAY
The TaqPath COVID-19 Combo Kit, manufactured by ThermoFisher Scientific, that uses real-time reverse transcription polymerase chain reaction (RT-PCR) and is intended for the qualitative detection of nucleic acids from SARS-CoV-2 in upper respiratory specimens isolated from swabs. This test is EUA authorized for use with RNA extracted from patients at risk of exposure to SARS-CoV-2 or with signs and symptoms of COVID-19.
SARS-CoV-2 nucleic acid is first extracted, isolated and purified from upper respiratory specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection with the TaqPath COVID-19 Combo Kit on the Thermo Scientific KingFisher instrument, or other authorized instrumentation.
HOLOGIC PANTHER SARS-COV-2 ASSAY
The Hologic Panther SARS-CoV-2 Assay is a transcription mediated amplification (TMA) in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal (NP), nasal, and oropharyngeal (OP) swab specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria.
Download the requisition.
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