Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Infectious Diseases

Synonym/Aliases

Genexpert, Tb/rif Pcr; Genexpert Tb/rif Ultra Pcr

Abbreviations

TB PCR; TB/RIF PCR

Type

Profile/ Panel (Bundled Tests)

Results

RESULTS READY WITHIN 24-48 HOURS.

Method

AUTOMATED REAL TIME PCR

Temp

ROOM TEMPERATURE (3 DAYS), 2-8ºC (7 DAYS).

Setup

BATCHED

Components Parameters

M. Tuberculosis Complex, Rifampicin Resistance As Applicable.

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. SPECIFY EXACT SAMPLE TYPE.

Patient preparation

PATIENT INSTRUCTIONS SHOULD BE PROVIDED FOR SPUTUM COLLECTION (SALIVA SHOULD NOT BE SUBMITTED)

Sample type

VARIABLE DEPENDING ON SUSPECTED SITE OF INFECTION E.G. PULMONARY (SPUTUM, BRONCHOALVEOLAR LAVAGE. STOOL OR GASTRIC ASPIRATE FOR <5 YEAR OLDS UNABLE TO EXPECTORATE SPUTUM); PLEURAL (PLEURAL BIOPSY, PLEURAL FLUID); GASTROINTESTINAL (ASCITIC/ PERITONEAL FLUID, TISSUE BIOPSY), LYMPH NODES (BIOPSY OR ASPIRATE), CENTRAL NERVOUS SYSTEM (CSF), MUSCULOSKELETAL (SYNOVIAL FLUID, PUS, TISSUE) ETC.

Container/ preservative

STERILE, LEAK PROOF, PLASTIC CONTAINER

Sample volume

3 ML/ 1x1CM TISSUE

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE; INSUFFICIENT SAMPLE; BLOOD STAINED SAMPLE.

Other Instructions

- N/A

Reference intervals

NOT DETECTED/ NEGATIVE FOR MYCOBACTERIUM TUBERCULOSIS.

Clinical Utility

DETECTION OF MYCOBACTERIUM TUBERCULOSIS & RIFAMPICIN RESISTANCE. THE LATTER IS USED AS AN INDICATOR OF POSSIBLE MULTI DRUG RESISTANT TUBERCULOSIS.

Test Limitations/ Confounders

- N/A