MMQCI INTROL^® TB Panel M114

Part Number: M114-5

Kit Contains:    15 bottles x 1.0mL

5 each TBWT-04, TBMDR1-04 & TBNEG

INTROL® TB Panel M114-5 DataSheet

INTROL® TB Panel M114-10 DataSheet

INTENDED USE:

INTROL^® TB Panel M114 is intended for use as a quality control to monitor analytical performance of M. tuberculosis (MTB) on the GeneXpert^® System. INTROL^™ TB Panel M114 is formulated to monitor the detection of MTB and multi-drug resistant MTB (MDR-TB) mutations.

The World Health Organization (WHO) reports that about 1.7 billion people, 23% of the world’s population, are estimated to have a latent TB infection, and are thus at risk of developing active TB disease during their lifetime.¹ There has been major progress in subsequent years – more than 60 million people have been documented as treated and cured since 2000, and case and death rates have fallen steadily. Nevertheless, worldwide, around 10 million people still fall ill with the disease each year (more adults than children, and more men than women), and TB is one of the top 10 causes of death. It is also the leading cause of death from a single infectious agent, ranking above HIV/AIDS. ²

INTROL^® TB Panel M114 is provided for Research Use Only (RUO). It cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

PRODUCT SUMMARY and PRINCIPLE:

INTROL^® TBWT-04 and TBMDR1-04 of INTROL^® TB Panel M114 consist of non-infectious, synthetic MTB DNA encapsulated in chemically fixed and killed bacterial cells. The MTB DNA does not include the entire MTB genome but is comprised of the following MTB gene segments: IS6110, hsp65, 16S rRNA, 23S rRNA, inhA, katG, and rpoB. Drug resistance mutations are incorporated in segments inhA, katG, and rpoB, as indicated in Table 1.

Best practice is to establish a quality control program for every assay performed by the laboratory.^{3, 4} Routine use of quality controls that are consistent lot to lot and monitor the entire assay assists the laboratory in identifying shifts, trends, and increased frequency of random errors caused by variations in the test system, such as failing reagents and pipetting errors. Early investigation can prevent failed assay runs.

COMPOSITION:

INTROL^® TB Panel M114 (P/N: M114-5) is comprised of 5 kits & INTROL^® TB Panel M114 (P/N: M114-10) is comprised of 10 kits; each kit is comprised of three bottles, 1 mL each. Two bottles contain encapsulated MTB DNA, gene segments IS6110, hsp65, 16S rRNA, 23S rRNA, inhA, katG, and rpoB. The third bottle contains buffer and preservative only. The cells encapsulating the MTB DNA are suspended in buffer with preservative. The presence or absence of drug resistance mutations is specified for each bottle in Table 1.

Table 1. Drug Resistance Mutations* found in INTROL^® TB Panel M114

*References citing the mutations can be found at www.tbdreamdb.com.

PRECAUTIONS AND WARNINGS:

INTROL^® TB Panel M114 is for use on the GeneXpert^® System only. It cannot be cloned, sold, or transferred without the explicit written consent of MMQCI. This product does not contain any biological material of human origin or infectious microorganisms. Do not freeze.

STORAGE and STABILITY:

Upon receipt and after opening, the material should be stored at 2° – 8°C. Do not freeze.

Unopened controls are stable through the expiration date printed on each bottle when stored at 2° – 8°C. Opened material tightly capped and returned to the refrigerator (2° – 8°C) shortly after use is stable for thirty (30) days from the date of opening.

INSTRUCTIONS FOR USE:

1. Each bottle contains 0mL of control material.
2. Allow controls to come to room
3. Thoroughly mix controls by vigorously inverting several times immediately before
4. Before opening bottle, shake down or tap bottle on hard surface to be sure all liquid is out of
5. Add 2 mL Sample Reagent to each control
6. Mix by inverting the vial 10
7. Let the vial sit at room temperature for 15 minutes. Invert several times half way through incubation period as you would for a sputum sample.
8. Open the Xpert^® MTB/RIF cartridge lid and transfer 0 mL of respective Sample Reagent treated control, using a sterile transfer pipette. Close lid.
9. Transfer cartridge to the GeneXpert
10. Scan cartridge, enter sample ID and start the

LIMITATIONS:

INTROL^® TB Panel M114 is designed for use with MTB amplification assays that target one or more of the following MTB gene segments: hsp65, rpoB, 16S rRNA, 23S rRNA, inhA, katG, and IS6110. Only those segments are present in INTROL^® TB Panel M114.

EXPECTED VALUES:

 REFERENCES:

1. WHO report 2018: https://who.int/tb/publications/global_report/en/
2. “Ten Facts About Tuberculosis,” WHO, September 2018: http://www.who.int/features/factfiles/tuberculosis/en/index.html
3. ISO 15189: Medical laboratories – Particular requirements for quality and
4. CAP Molecular Pathology Checklist; Commission on Laboratory Accreditation, Laboratory Accreditation Program, Mol.20000