Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Directions
Follow good laboratory procedures when working with Mycobacteria cultures and specimens. Perform all work in Biological safety cabinet. For inoculations use calibrated loop or micropipette. Ensure that all the specimen and used slants are immersed in suitable disinfectant or preferably 2% gluteraldehyde for minimum two hours before disposal. The Drug Susceptibility Test is carried out for 1) Either sputum sample previously subjected to decontamination and concentration process. Inoculate 10µl of the processed specimen on slants. OR 2)Pure culture of Mycobacteria isolated from a clinical sample.
Preparation of inoculum:
Take a loopful aseptically from the M. tuberculosis growth, primarily isolated on L. J. medium slant. Suspend the sample in 1.0ml of sterile distilled water in a screw capped bottle. (Recommended to use glass beads of 3.0mm diameter for better homogenization and declumping of cells). Further homogenize the mixture on a vortex mixture up to 10 minutes. Keep standing for 10 minutes before opening the bottle. adjust opacity of suspension to match McFarland 0.5 standard with saline giving approximately 1.5x 108 cfu/ml. Dilute this suspension to 1:10000.
Principle And Interpretation
Based on invitro correlation between the clinical response to antimicrobial agent and the result of invitro susceptibility testing kit (SL023) helps in diagnosing the sensitivity pattern of M. tuberculosis affected patient and accordingly provide treatment, drug therapy for the patients. Primary drug resistance for M. tuberculosis is defined as resistance to an antimicrobial drug in an organism isolated from a patient who has not previously received antituberculosis therapy. Therefore drug resistance applies to previously untreated patients who are found to have drug resistant organisms presumably because they have been infects from an outside source of resistant M. tuberculosis. Acquired (or secondary) drug resistance is due to importantly because of non-adherence in drug taking.
Type of specimen
Clinical samples: Sputum
Specimen Collection and Handling
Mycobacteria susceptibility test can be inoculated either directly from digested and concentrated smear positive sputum (direct test) or from a pure culture of Mycobacteria isolated from a clinical specimen (indirect test). The direct test is usually done only on specimens showing Mycobacteria on smear and give the best results when large no. of Mycobacteria are present. The advantage of the direct test is that a much earlier report of susceptibility studies (3 to 4 weeks) can be made than with indirect test which may take up to 5 to 7 weeks, but can be frequently be complicated by over growth with other bacteria that have survived the decontamination procedure. 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
- Certain gram-positive contaminants (e.g. Streptococci) and gram-negative bacilli may grow on the medium.
- Certain Saprophytes may also grow on the medium.
- Proteolytic contaminants cause localized or complete digestion of medium.
- Further biochemical and serological identification is necessary for confirmation.
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: Pale bluish green coloured, smooth slants containing five antitubercular drugs (Isoniazide, Streptomycin, Ethambutol, Rifampicin, Pyrazinamide of pH 5.5)plus two controls in long tubes.
Cultural response: Cultural response observed after an incubation at 35-37°C under 5-10% CO2 for 2-4 weeks(further growth may be observed for 6-8 weeks)
Sterility check: Passes release criteria
| Organism | Inoculum | Growth on control slant pH 6.8 | Growth on control slant pH 5.5 | Colony characteristics on control slants | Growth on slant w/ Isoniazide | Growth on slant w/ Streptomycin | Growth on slant w/ Ethambutol | Growth on slant w/ Rifampicin |
|---|---|---|---|---|---|---|---|---|
| M. tuberculosis H37Rv ATCC 25618 | Standardized inoculum giving approximately 1000000 cfu/ml | Luxuriant | Luxuriant | Granular, rough, warty,dry, friable colonies | Inhibited | Inhibited | Inhibited | Inhibited |
Storage and Shelf Life
On receipt store between 2-8°C.Use before expiry date on thelabel. 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 (1,2).
| Product Name | Tuberculosis First Line Kit (Total 7 slants) |
|---|---|
| SKU | SL023L |
| Customized Product Available | No |
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