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COVID-19

Molecular Pathology

Test Code

COVID19

CPT Code

U0004, 87635

Specimen Transport

Specimens Collected using Aptima Multitest

  • Specimens can be sent room temperature, refrigerated, or frozen

Specimens Collected in VTM, UTM, or Saline

  • Send refrigerated (with cold packs) or frozen (-20°C)
  • Specimen may be transported at room temperature if they are received within 24 hours of collection

Specimen Stability

Specimens Collected using Aptima Multitest

  • Room temperature — 6 days
  • Refrigerated — 3 months
  • Frozen — 6 months

Specimens Collected in VTM, UTM, or Saline

  • Room temperature — up to 24 hours
  • Refrigerated — 4 days
  • Frozen — 30 days

Rejection Criteria

Cotton-tip swabs in UTM/VTM; swabs with calcium alginate; swabs with wooden shafts

Transport Container / Specimen

  • Aptima Multitest Swab (orange label)
  • Nasopharyngeal (NP) specimen*
  • Oropharyngeal (OP) specimen*

*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, swabs with preservatives, and swabs with wood shafts.

Turn Around Time

24 - 48 hours

Collection

Nasal Swab Collection

  1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection Kit.
  2. Hold the swab, 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.
  3. Carefully insert the swab into the first nostril until resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab a few times against the nasal wall and remove from nostril.
  4. Using the same swab, carefully insert the swab into the second nostril until resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab a few times against the nasal wall and remove from nostril.
  5. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
  6. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
  7. Carefully break the swab shaft at the score line against the side of the tube.
  8. Immediately discard the top portion of the swab shaft.
  9. Tightly screw the cap onto the tube.

Oropharyngeal (OP) Collection

Collection for throat swab specimens.

  1. Partially open the swab package and remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, laid down, or dropped, discard and get a new Aptima Multitest Swab Specimen Collection Kit. Hold the swab, placing thumb and forefinger in the middle of the shaft covering the black score line. Do not hold the shaft below the score line.
  2. Carefully insert the swab into the 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.
  3. While holding the swab in hand, unscrew the tube cap. Do not spill the tube contents. If the tube contents are spilled, discard and replace with a new Aptima Multitest Swab Specimen Collection Kit. Immediately place the swab into the transport tube so the black score line is at the top of the tube. Align the score line with the top edge of the tube and carefully break the shaft. The swab will drop to the bottom of the tube. Discard the top portion of the swab shaft.
  4. Tightly screw the cap onto the tube. When collecting multiple specimens from the same patient, the tube label provides a specimen source field for unique identification for the specimen location.
  5. Ship frozen at -20°C (preferred); refrigerated specimens acceptable (if received for testing within 72 hours of collection).

Nasopharyngeal (NP) Collection

Swab specimens should be obtained from the posterior nasopharynx. Ideally two swabs should be collected although one is acceptable. Swab shaft should be aluminum or flexible plastic. Cotton-tipped or calcium alginate swabs are not acceptable. Ask patient if he/she has a deviated septum and then have patient clear nasal passages by blowing his/her nose.

  1. Tilt patient’s head back to a 70˚ angle. Check for nasal obstructions.
  2. 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 (swab should reach depth equal to distance from nostrils to outer opening of the ear). Be careful not to insert swab upwards. Do not force the swab. If there is an obstruction, try the other nostril. Leave swab in place for up to 10 seconds to absorb secretions. Slowly remove swab while rotating it.
  3. While holding the swab in hand, unscrew the tube cap. Do not spill the tube contents. Place the swab specimen into 3mL of VTM. The following types of VTM were verified for use:
    • Remel MicroTest M4, M4RT, M5 or M6 formulations
    • Copan Universal Transport Medium
    • BD Universal Viral Transport Medium
  4. Immediately place the swab into the transport tube and seal. If score line is present, break swab at the score line at the top of the tube. The swab will drop to the bottom of the vial. Discard the top portion of the shaft. Tightly screw the cap onto the tube.
  5. Use label to provide a unique identification for the specimen. After collection, specimens can be stored at 2°C to 8°C up to 96 hours.

Test Setup

Monday - Saturday (days)

Methodology

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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