Mycobacterium tuberculosis Detection, NAA Without CAP-mandated Culture

CPT: 87556
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Test Details

Use

Detect and identify Mycobacterium tuberculosis complex in respiratory and other defined specimen types. Per the College of American Pathologists (CAP) guidelines, a culture must be performed on all samples regardless of the molecular test result (MIC.64820). By ordering this test, the client has assumed responsibility for performance of the culture.

Limitations

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA).

Methodology

Nucleic acid amplification (NAA)

Specimen Requirements

Specimen

Sputum, respiratory aspirate, lavage fluid, pleural fluid, cerebrospinal fluid (CSF), or respiratory tissue

Volume

5 mL, 1 mL CSF, or a small piece of respiratory tissue (2 mm from needle biopsy)

Container

Sterile screw-cap container; seal cap tightly.

Patient Preparation

When collecting sputum, have the patient brush teeth or remove dentures and rinse mouth with water. Instruct the patient not to collect saliva. When collecting aspirates, use standard aseptic preparation. Respiratory tissue specimens may be fresh or frozen.

Collection

If the specimen is to be split for additional testing, it should be divided so that each portion is transported at the appropriate temperature.

Storage Instructions

Refrigerate.

Causes for Rejection

Quantity not sufficient; specimen received after leaking out of transport container into specimen bag; syringe with attached needle; inappropriate or expired specimen transport device; unlabeled specimen container or container with a single patient identifier; name discrepancy between specimen container label and the computer or the requisition; specimen received after prolonged delay (usually more than 72 hours unless frozen); blood and bone marrow are not suitable for amplification test and will not be tested. Tissue not of respiratory origin will not be tested.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
183059 MTB NAA Without AFB Culture 13956-8 183073 M tuberculosis, NAA 13956-8
183059 MTB NAA Without AFB Culture 13956-8 183646 AFB Specimen Processing 8100-0

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