Test #
237
Test CPT Codes
86769, U0004
COVID-19 Comprehensive Evaluation (Includes Tests 230, 231)
Test Type
Molecular, Diagnostic Immunology
Test Technology
RT-PCR, Chemiluminescence
Test Disease
SARS-CoV-2 Infection
Clinical Utility
Diagnostic & Follow-up
Test Specimen
230: 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).
231: Serum/Plasma
Specimen Requirements
3 mL; Minimum : 1 mL
Specimen Collection
230: Nasal and Throat Swab: 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.
231: Serum separator tube (preferred), plasma tube acceptable
Reporting
230: RNA Not Detected, Detected, Indeterminate, Invalid, Quantity not Sufficient (QNS)
231: IgG Antibody-Unit/Index & Reported Values <0.8 Cut-off Index (COI)- Negative; 0.8 to <1.0 COI - Indeterminate; ≥1.0 COI – Positive,: Invalid; QNS
PB TAT
3-5 days
BM TAT
3-5 days
Tissue TAT
FFPE TAT
Test Storage
230: Swab: 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).
231: Sera/plasma: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles).
Transport Conditions
230: Ship frozen (-20oC, preferred), Refrigerated (4oC) acceptable if received in 72 hours, Room Temperature if received within 24 hours
231: Transport collection Ambient: 48 hours; Refrigerated acceptable; frozen serum or plasma if separated for blood cells
Rejection Criteria
230: 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.
231: Serologic specimens: Contaminated, heat-inactivated, hemolyzed, or severely lipemic specimens frozen whole blood in sample.