237

Test CPT Codes

86769, U0004

Test Type

Molecular, Diagnostic Immunology

Test Disease

COVID-19 Infection

Test Technology

Chemiluminescence, RT-PCR, Elisa

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

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 (-20°C, preferred), Refrigerated (4°C) 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.

Turnaround Time (TAT)

≤ 2 days