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.

  • 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.

Contact Us

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