(mb HAIN LPA) TEST, GENOTYPE MTBDRplus v2.0, 1 test, 30496A

KIT composed of 2 separate elements with different storage conditions:

• component 1/2 (cardboard box) to be stored between 2° and 8°C
• component 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 (MTBDRplus VER 2.0 STRIPS), 2x48 strips
• Denaturation Solution (DEN) contains <2% NaOH, dye, 2x1.2 ml
• Hybridization Buffer (HYB) contains 8-10% 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% anionic 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 dimethyl sulfoxide, substrate solution, 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 MTBDRplus VER 2.0) contains buffer, nucleotides, Taq polymerase, 4x 0.3 ml
• Amplification Mix B (AM-B GT MTBDRplus VER 2.0) contains salts, specific primers, dye, 4x 1.05 ml

Quality control

In order to control the correct performance of the test and the proper functioning of kit constituents, each strip includes 5 control zones:

• a Conjugate Control zone (CC) to check the binding of the conjugate on the strip and a correct chromogenic reaction
• an Amplification Control zone (AC) to check for a successful amplification reaction
• three Locus Control zones (rpoB, katG, and inhA) checking the optimal sensitivity of the reaction for each of the tested gene loci

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 AC 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 to 15 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.