Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Intended Use
Recommended for selective isolation of Helicobacter pylori from clinical samples.
Composition
| Ingredients | g/L |
|---|---|
| Peptone, special | 23.000 |
| Corn starch | 1.000 |
| Sodium chloride | 5.000 |
| Agar | 15.000 |
| Sterile Defibrinated Sheep Blood | 70 ml |
| Vancomycin | 0.010 |
| Trimethoprim | 0.005 |
| Cefsulodin | 0.005 |
| Amphotericin B | 0.005 |
| Final pH (at 25°C) | 7.3±0.2 |
**Formula adjusted, standardized to suit performance parameters
Directions
Either streak, inoculate or surface spread the test inoculum (50-100 CFU) aseptically on the plate. The plate should be directly inoculated with the clinical specimen or the transport medium or broth that has been inoculated with the clinical specimen. It should be incubated immediately under CO2 to minimize the recovery loss.
Principle And Interpretation
Helicobacter organisms is known cause of peptic ulcers in humans. It is a common type of bacteria that grows in the digestive tract and has a tendency to attack the stomach lining. They attack stomach and small intestine. They cause sores, called ulcers, in the lining of stomach or the upper part of your small intestine. At times this infection often lead to stomach cancer (1,2) Helicobacter pylori, previously known as Campylobacter pylori, is a Gram-negative, microaerophilic bacterium usually found in the stomach (3).
Helicobacter pylori Selective Agar Base which is with different combinations of antimicrobial agents are used for isolation and cultivation of Helicobacter pylori (4). Corn starch serves as an energy source and also neutralizes toxic metabolites. Peptone special provides nitrogenous sources. Sodium chloride maintains osmotic equilibrium of the medium. Vancomycin inhibits gram positive Staphylococcus, Streptococcus and Bacillus species. Amphotericin inhibits contaminating fungi while other enteric bacteria can be inhibited by Trimethoprim. Cefsulodin inhibits Pseudomonas aeruginosa. Sheep blood permits the detection of hemolysis and also provides heme (X factor) which is required for the growth of Helicobacter species. In general Campylobacter species are best grown at 42°C in a micro aerophillic atmosphere. Plates may be incubated in an atmosphere containing approximately 3-10% CO2 for recovery of Helicobacter species. Confirm the identity of the isolates as Gram negative, curved or spiral bacillus, Catalase positive, Oxidase positive, Urease positive and Hippurate negative.
Type of specimen
Clinical samples: Fresh Gastric biopsy specimen
Specimen Collection and Handling
For clinical samples follow appropriate techniques for handling specimens as per established guidelines (3,4).
After use, contaminated materials must be sterilized by autoclaving before discarding.
Warning and Precautions
In Vitro diagnostic use only. For professional use only. Read the label before opening the container. Wear protective gloves/ protective clothing/eye protection/face protection. Follow good microbiological lab practices while handling specimens and culture. Standard precautions as per established guidelines should be followed while handling clinical specimens. Safety guidelines may be referred in individual safety data sheets.
Limitations
- Helicobacter species are very sensitive to aerobic atmosphere therefore inoculate the specimen on suitable medium as soon as possible to avoid viability loss.
- Other Helicobacter species may also grow on this media. Therefore carry our biochemcial and confirmatory tests of the suspected Helicobacter colonies.
- Faeces specimens are not recommended as Helicobacteria are present in a non- culturable (coccoid) form.
- Individual organisms differ in their growth requirement and may show variable growth patterns on the medium
- Each lot of the medium has been tested for the organisms specified on the COA. It is recommended to users to validate the medium for any specific microorganism other than mentioned in the COA based on the user's unique requirement.
Performance and Evaluation
Performance of the medium is expected when used as per the direction on the label within the expiry period when stored at recommended temperature.
Quality Control
Appearance
Sterile Helicobacter pylori Selective Agar Plate in 90 mm disposable plate with smooth surface and absence of black particles/cracks/bubbles
Colour of medium
Red coloured medium
Quantity of medium
25 ml of medium in 90 mm Petri plate
pH
7.10 - 7.50
Sterility check
Passes release criteria
Cultural Response
Cultural characteristics observed after an incubation at 35-37°C for 18-48 hours under microaerophilic conditions (5-10% CO2).
| Organism | Inoculum (CFU) | Growth | Recovery | Haemolysis |
|---|---|---|---|---|
| Helicobacter pylori ATCC 43526 | 50-100 | luxuriant | >=50% | none |
| Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) | >=103 | inhibited | 0% | - |
| Candida albicans ATCC 10231 (00054*) | >=103 | inhibited | 0% | - |
Key: (*) Corresponding WDCM numbers.
Storage and Shelf Life
On receipt store between 2-8°C. Use before expiry date on the label. Product performance is best if used within stated expiry period.
Disposal
User must ensure safe disposal by autoclaving and/or incineration of used or unusable preparations of this product. Follow established laboratory procedures in disposing of infectious materials and material that comes into contact with clinical sample must be decontaminated and disposed of in accordance with current laboratory techniques (5,6).
| Product Name | Helicobacter pylori Selective Agar Plate |
|---|---|
| SKU | MP5390 |
| Customized Product Available | No |
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