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

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)

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.

1 kit = 96 tests

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

• See: MSF diagnostic packages, MSF, 2023

• 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).

• 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)

• 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.