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Mycobacterium tuberculosis Complex, PCR, Non-Respiratory

Test Summary

Used to aid the physician in the rapid diagnosis and treatment of a possible tuberculosis infection.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

1 mL CSF, gastric lavage, pericardial fluid, peritoneal fluid, pleural fluid, synovial fluid, abscess fluid or urine collected in a sterile, plastic leak-proof container or whole blood collected in an EDTA lavender top tube. Also acceptable 2 grams fresh (unfixed) tissue collected in a sterile, plastic leak-proof container or with a small amount of saline with no fixatives or preservatives or 0.5 mL vitreous (eye) fluid.

Minimum Volume

0.5 mL, 2 g tissue, 0.2 mL vitreous fluid

Instructions

Gastric lavage: Sterile leak-proof container. Must be neutralized with sodium bicarbonate within 4 hours of collection and store refrigerated.

Tissue: Fresh (unfixed) tissue submitted in a sterile, plastic, leak-proof container or Fresh (unfixed) tissue in a sterile plastic leak-proof container with a small amount of saline with no fixatives or preservatives and store refrigerated or frozen.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Vitreous (eye) fluid: Frozen
All other samples: Refrigerated (cold packs)

Specimen Stability

  • Room temperature: 48 hours
  • Refrigerated: 14 days
  • Frozen: 30 days
  • Vitreous (eye) fluid must be frozen

Limitations

N/A

Other Acceptable Specimens

0.5 mL vitreous (eye) fluid in a sterile leak-proof container

Unacceptable Specimens

Sputum, specimen received in formalin and/or alcohol,  processed/concentrated specimen from client; swabs, formalin-fixed paraffin-embedded tissue, culture isolates, non-neutralized gastric lavage

Order Code

MTBNON

EPIC (Premier) Code

LAB3424

Includes

N/A

CPT Code

  • 87556

Billing Code

  • 670906

CPT Statement

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)

FDA Status

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. This test should not be used for diagnosis without confirmation by other medically established means.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

Not detected

Setup Schedule / Expected Turnaround Time

Daily; Report available: 1 - 3 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

1 mL CSF, gastric lavage, pericardial fluid, peritoneal fluid, pleural fluid, synovial fluid, abscess fluid or urine collected in a sterile, plastic leak-proof container or whole blood collected in an EDTA lavender top tube. Also acceptable 2 grams fresh (unfixed) tissue collected in a sterile, plastic leak-proof container or with a small amount of saline with no fixatives or preservatives or 0.5 mL vitreous (eye) fluid.

Minimum Volume

0.5 mL, 2 g tissue, 0.2 mL vitreous fluid

Instructions

Gastric lavage: Sterile leak-proof container. Must be neutralized with sodium bicarbonate within 4 hours of collection and store refrigerated.

Tissue: Fresh (unfixed) tissue submitted in a sterile, plastic, leak-proof container or Fresh (unfixed) tissue in a sterile plastic leak-proof container with a small amount of saline with no fixatives or preservatives and store refrigerated or frozen.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Vitreous (eye) fluid: Frozen
All other samples: Refrigerated (cold packs)

Specimen Stability

  • Room temperature: 48 hours
  • Refrigerated: 14 days
  • Frozen: 30 days
  • Vitreous (eye) fluid must be frozen

Limitations

N/A

Other Acceptable Specimens

0.5 mL vitreous (eye) fluid in a sterile leak-proof container

Unacceptable Specimens

Sputum, specimen received in formalin and/or alcohol,  processed/concentrated specimen from client; swabs, formalin-fixed paraffin-embedded tissue, culture isolates, non-neutralized gastric lavage

Billing

CPT Code

  • 87556

Billing Code

  • 670906

CPT Statement

Result Information

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)

Testing Laboratory

N/A

Reference Range

Not detected

Setup Schedule / Expected Turnaround Time

Daily; Report available: 1 - 3 days