(mb Hain LPA) DNA MANUAL EXTRACTION GENOLYSE KIT, 51610

STD ELAEMBIC511

Valid Article

Former Code(s): ELAEMBIT508
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.
18
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) DNA MANUAL EXTRACTION KIT (GenoLyse®)

Reserved for TB culture programmes.

Definition

Kit for the manual extraction of bacterial DNA for further use with GenoType MTBDRplus, GenoType MTBDRsl and GenoType Mycobacterium CM.

Specifications

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Components

Material provided

Kit contains sufficient reagents for extraction of 96 samples.

Quality control

It is advisable to include one negative control in each extraction procedure for detection of possible contamination. Negative control can be prepared pipetting 100 microliter of Lysis Buffer (A-LYS) into a 1.5 ml screw cap tube and proceed as a the other samples.

Technical specifications

  • Lysis Buffer (A-LYS) contains 1% nonionic tenside, <0.2% NaOH, dye, 12ml
  • Neutralization Buffer (A-NB) contains buffer, 12ml
  • Instructions for use

Packaging & Labelling

1 kit = 96 extractions

To be Ordered Separately

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

Instructions for use

The procedure is divided into three steps:

  • Pelleting of cells for removal of sample liquids
  • Lysis unders alkaline conditions at elevated temperature
  • Neutralitzation. The extracted genomic DNA may directly by used or can be stored at -20ºC.
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Precautions for Use

The kit constituents are not classified as hazardous substances. However, suitable protective clothing and gloves should always be worn.

Storage

  • Store all kit components at 2-8ºC.
  • Do not use the reagents beyond their expiry date.
  • Shelf life: 18 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(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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