(mb Hain LPA) TEST, MYCOBACTERIUM CM, VER 2.0, 1 test 29996A

STD ELAEMBIT504

Valid Article

Former Code(s): SLASZFR0422 DDGTZNL0187 SSDTTUBG96T2 ELAEPCRT003 ELAELPAT103 ELAEPCRT504
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
The order of this product needs to be justified and is only acceptable under certain conditions.
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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(mb HAIN LPA) TEST, GENOTYPE MYCOBACTERIUM CM

Reserved for TB culture programmes

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 96.

Definition

The GenoType Mycobacterium CM VER 2.0 is a qualitative in vitro test for the identification of the Mycobacterium tuberculosis complex as well as the differentiation of following 27 NonTuberculous Mycobacteria (NTM) from cultured material: M. avium, M. chelonae, M. abscessus complex, M. fortuitum group, M. gordonae, M. intracellulare, M. scrofulaceum, M. szulgai, M. interjectum, M. kansasii, M. malmoense, M. marinum/M. ulcerans, and M. xenopi.

Specifications

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Components

KIT composed of 2 separate elements with different storage conditions:

  • component 1/2 (cardboard box) to be stored between 2° and 8°C
  • componenet 2/2 (small bag) to be stored at -20°C (deep freeze)

Technical specifications

Kit contains sufficient reagents for analysis of 96 samples.

Kit Component 1 of 2 (store at 2-8°C)

  • Membrane strips coated with specific probes Mycobacterium CM VER 2.0 STRIPS) 2x48
  • Denaturation Solution (DEN) contains <2% NaOH, dye 2x1.2 ml
  • Hybridization Buffer (HYB) contains <10% anionic tenside, dye 120 ml
  • Stringent Wash Solution (STR) contains >25% of a quaternary ammonium compound, <1% anionic tenside, dye 120 ml
  • Rinse Solution (RIN) contains buffer, <1% NaCl, <1% nonionic tenside 3x120 ml
  • Conjugate Concentrate (CON-C) contains streptavidin-conjugated alkaline phosphatase, dye 1.2 ml
  • Conjugate Buffer (CON-D) contains buffer, 1% blocking reagent, <1% NaCl 120 ml
  • Substrate Concentrate (SUB-C) contains <70% dimethyl sulfoxide, <10% 4-nitro blue tetrazolium chloride, <10% 5-bromo-4-chloro-3-indolyl phosphate 1.2 ml
  • Substrate Buffer (SUB-D) contains buffer, <1% MgCl2, <1% NaCl 120 ml
  • Tray, evaluation sheet 4 of each
  • Instructions for use, template 1 of each

Kit Component 2 of 2 (store at –20°C)

  • Amplification Mix A (AM-A GT Mycobacterium CM VER 2.0) contains buffer, nucleotides, Taq polymerase 4x0.3 ml
  • Amplification Mix B (AM-B GT Mycobacterium CM VER 2.0) contains salts, specific primers, dye 4x1.05 ml
  • Internal Control DNA (IC GT Mycobacterium CM VER 2.0) contains bacterial DNA 0.25 ml
  • Control DNA (C+ GT Mycobacterium CM VER 2.0) contains bacterial control DNA 0.1 ml

Quality control

In order to control the correct performance of the test and the proper functioning of kit constituents, each strip includes 3control zones:

  • Conjugate Control zone (CC) to check the efficiency of conjugate binding and substrate reaction.
  • Internal Control zone (IC) to check the procedure performance by a control amplicon.
  • Genus Control (GC), documents the presence of a member of the genus Mycobacterium.

A negative control sample for detection of possible contamination events containing water (molecular biology grade) instead of DNA should be part of each test run; the respective test strip should show the bands CC and IC only.

Packaging & Labelling

1 kit = 96 tests

To be Ordered Separately

Material Required but not Included in the Kit: see checklist molecular biology Hain.

Instructions for use

The GenoType Mycobacterium CM test is based on the DNA strip technology. The whole procedure is divided into three steps:

  • DNA extraction from cultured material (solid/liquid medium; the necessary reagents are not included in the kit)
  • a multiplex amplification with biotinylated primers
  • a reverse hybridization.

Visual interpretation of the results.

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Precautions for Use

  • It is essential that all materials (such as pipette tips) coming in contact with the reagents are free from DNases.
  • Do not interchange or pool Amplification Mixes or membrane strips from different kits unless the lots are identical.
  • When handling kit reagents, the following special safety measures must be applied:
    • The denaturation Solution (DEN) contains <2% NaOH and is irritating to eyes and skin (R36/38 and S26-37/39-45).
    • The Substrate Concentrate (SUB-C) contains dimethyl sulfoxide and is irritating (R36/37/38, S23-26-36).

Storage

  • Store all constituents from Kit Component 1 between 2° and 8°C.
  • Store all constituents from Kit Component 2 at –20°C and keep strictly separated from contaminating DNA.
  • Avoid repeated freezing and thawing of AM-A and AM-B; when processing only small sample numbers per run, aliquot AM-A and AM-B.
  • Shelf life: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
  • Do not use the reagents beyond their expiry date.

(Cf Introduction: Thermosensitive products)

Waste management

  • Dispose of unused reagents and waste in accordance with federal, state, and local regulations.
  • Discard used pipette tips immediately after use in a container for biohazardous waste.
  • Discard all used disposables in a container
  • for biohazardous waste to be incinerated.

MSF requirements

Molecular testing requires specific laboratory set up, equipment and trained personnel. Refer to your lab advisor.

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