Test #

230

Test CPT Codes

U0004

COVID-19 Virus Testing by RT-PCR

Test Type

Molecular

Test Technology

RT-PCR

Test Disease

SARS-CoV-2 Infection

Clinical Utility

Diagnostic

Test Specimen

  • Oropharyngeal (OP) collection in viral transport medium, ESwab™, or saline. Nasopharyngeal (NP) swabs also accepted in viral transport medium (discard OP swab included with viral transport medium), ESwab™, or saline. OP or NP washes/aspirates in sterile cups. Bronchial washing or bronchoalveolar lavage (BAL) specimens in sterile cups.

  • Additional specimens accepted include mid-turbinate swabs, nasal swabs, bronchoalveolar lavage (BAL) and nasopharyngeal aspirate (nasal aspirate).

Specimen Collection

  • For swabs in viral transport medium or ESwab™: 

  • Oropharyngeal (OP) samples: Swab included in viral transport medium or ESwab™ is acceptable for submission. 

  • Any swab of appropriate size and configuration with a synthetic tip and shaft can be used except for calcium alginate tips, swabs with preservatives, and swabs with wood or paper shafts. 

  • Viral transport medium acceptable for collection of influenza specimens in 1 mL or 3 mL volumes can be used to transport swabs for COVID-19 testing. 

  • For swabs in saline: 

  • OP or NP swabs may be placed in 1 to 3 mL of sterile saline (0.85 to 0.9%) in a sterile screw cap container. 

  • Do not use vacutainer or "pop-top" tubes. 

  • Sterile cups are acceptable for OP or NP washes/aspirates, bronchial washings, or bronchoalveolar lavage (BAL) specimens.

Reporting

  • Not Detected, Detected, Indeterminate, Invalid, Quantity not Sufficient (QNS)

PB TAT

3 days

BM TAT

3 days

Tissue TAT

FFPE TAT

Test Storage

Frozen at -20° C (preferred). Refrigerated specimens acceptable (if received for testing within 72 hours of collection). Room temperature swabs are acceptable (if received within 24 hours of collection).


Transport Conditions

  • Ship frozen (-20oC, preferred), Refrigerated (4oC) acceptable if received in 72 hours, Room Temperature if received within 24 hours


Rejection Criteria 

  • Specimens collected with: cotton-tip, Calcium Alginate or wood shaft swabs; or in Urinary or Vaginal transport media; Refrigerated samples greater than 72 hours old; Room temperature swabs greater than 24 hours old; Improperly labeled, grossly contaminated, broken or leaking transport device; Collection with substances inhibitory to PCR including heparin, hemoglobin, ethanol, EDTA concentrations >0.01M; Specimens submitted in glass tubes/containers.

Contact Us

1.8OO.96O.1O8O

1OOO Youngs Road  |  Suite 21O
Buffalo NY 14221 USA
716.431.5757 Fax
info@ksldx.com
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