(API System) NH STRIP Neisseria & Haemophilus [BMX-10400]

STD SBIDAPISNH-

Valid Article

Former Code(s): SLASZBD0085
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.
11
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0104080209 - Manual identification kits - anaerobes, pathogens - other
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
The order of this product needs to be justified and is only acceptable under certain conditions.
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
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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API NH STRIP, Neisseria & Haemophilus

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 10.

Definition

API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catarrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. The API NH strips enables the biotyping of Haemophilus influenzae and Haemophilus parainfluenzae, as well as the detection of a penicillinase.

Inoculation and reading are done manually, and identification is done with the software.

Specifications

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Components

R1 ZYM B: contains methanol

Kit containing:

  • 10 API NH strips
  • 10 ampules of API NaCl 0.85 % Medium (2 ml)
  • 1 ampule of JAMES reagent (R1 - 5 ml) solvent + 1 bottle of JAMES (R2 - 0.033 g) reagent
  • 1 ampule of ZYM B (R1 - 5 ml) solvent + 1 bottle of ZYM B (R2 - 0.007 g) reagent
  • 10 incubation boxes
  • 10 result sheets
  • 1 package insert provided in the kit.

Technical specifications

Strips consisting of 10 microtubes containing dehydrated substrates which enable the performance of 12 identification tests (enzymatic reactions or sugar fermentations), as well as the detection of a penicillinase.

The colours changes occur during incubation, due to metabolism, spontaneously or by addition of reagents.

  • R1 James: clear colorless or nearly colorless liquid
  • R2 James: solid off-white powder
  • R1 ZYM B: clear colorless or nearly colorless liquid
  • R2 ZYM B: solid off-white powder
  • ZYM B after reconstitution is yellow to amber

Packaging & Labelling

Kit of 10 strips and associated reagents

Transport Dangerous Goods

Zym B - R1 :

  • UN1992
  • Class: 3 (6.1)
  • Packing group: III
  • Proper shipping name: Flammable liquid, toxic, n.o.s (Methanol Solution)

James - R1:

  • UN1789
  • Class: 8
  • Packing group: III
  • Proper shipping name: Hydrochloric acid.

Chemical kit:

  • UN3316
  • Class: 9
  • Packing group: III
  • Proper shipping name: Chemical kit

To be Ordered Separately

  • Mineral oil
  • McFarland Standard, No. 4 on the scale
  • Swabs
  • Pipettes or PSIpettes
  • Ampule rack
  • Ampule protector
  • General microbiology laboratory equipment.
  • ATB™ NEW and APIWEB™ software for identification

Instructions for use

Follow the instructions of the package insert

Please consult the “Bacteriology laboratory procedures and resources” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Bacteriology-Laboratory-Resources.aspx

For offline access, contact your laboratory advisor

Precautions for Use

All biological samples must be considered as potentially infectious and handled with the usual precautions (compulsory wearing of gloves, hand washing, etc.).

Storage

  • Shelf life: 11 months.
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life.

Strips:

  • Store between 2°C and 8°C.
  • Do not use after expiry date.

Media:

  • Store between 2°C and 30°C.
  • Do not use after expiry date.

Reagents:

  • Store between 2°C and 8°C.
  • Store in the dark. Wrap the bottles of JAMES reagents in aluminium foil.
  • The JAMES reagent may be kept up to 1 month after the ampules have been opened and the reagents reconstituted.
  • The ZYM B reagent may be kept up to 2 weeks after the ampules have been opened and the reagents reconstituted.
  • Make sure that the reagents are put back in the fridge immediately after use.

(Cf Introduction: Thermosensitive products)

Waste management

After use, sterilize the cultures and all contaminated material.

Contains substances with‌ hazardous and carcinogenic characteristics. Please contact your watsan referent for advice on proper disposal.

Detailed hazard and precautionary information can be found in the safety data sheet (SDS).

Classification EC Regulation N° 1272/2008

JAMES - R1:

  • Skin corrosion/irritation, category 1, H314
  • Serious eye damage/eye irritation, category 1, H318

​ZYM B - R1:

  • Flammable liquids, Category 3, H226
  • Acute toxicity, oral, Category 4, H302
  • Acute toxicity, dermal, Category 3, H311
  • Acute toxicity, inhalation, Category 3, H331
  • Specific target organ toxicity - single exposure, Category 1, H370
Image Image

Signal Word

(James R1 and James R2)

Danger - R1

Warning - R2

H314Causes severe skin burns and eye damage.
H315Causes skin irritation
H318Causes serious eye damage.
H319Causes serious eye irritation
H335May cause respiratory irritation
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P264Wash … thoroughly after handling
P280Wear protective gloves/protective clothing/eye protection/face protection
P310Immediately call a POISON CENTER or doctor/physician.
P363Wash contaminated clothing before reuse.
P301 + P330 + P331IF SWALLOWED: rinse mouth. Do NOT induce vomiting
P302 + P352IF ON SKIN: wash with plenty of soap and water
P303 + P361 + P353IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing.
P304 + P340IF INHALED: Remove to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations

Signal Word

Danger

Image Image Image
H226Flammable liquid and vapour.
H302Harmful if swallowed
H311Toxic in contact with skin.
H331Toxic if inhaled.
H370Causes damage to organs (or state all organs affected, if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard).
P210Keep away from heat/sparks/open flames/hot surfaces. – No smoking.
P280Wear protective gloves/protective clothing/eye protection/face protection
P301 + P312IF SWALLOWED: call a POISON CENTER or doctor/physician if you feel
P302 + P352IF ON SKIN: wash with plenty of soap and water
P304 + P340IF INHALED: Remove to fresh air and keep at rest in a position comfortable for breathing.

Signal Word

Warning

Image Image
H302Harmful if swallowed
H351Suspected of causing cancer (state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard).
P280Wear protective gloves/protective clothing/eye protection/face protection
P301 + P312IF SWALLOWED: call a POISON CENTER or doctor/physician if you feel
P308 + P313IF exposed or concerned: Get medical advice/attention.

MSF requirements

Reserved to bacteriology programmes.

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