Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate,
Thane(W)-400604, MH, India.
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Intended Use
HiMedia's Liquid Transport Medium is specially designed transport system to collect and transport specimen samples in suspension form. with 2.0 ml TSB Medium MS2016B and one swab recommended for collection & transport of aerobic, anaerobic and fastidious organisms from rectum.
Contents
HiMedias HiCulture™™ Transport swabs w/Cary Blair Medium (A) consists of
| Sterile Cary Blair Medium, in tube | 2.0 ml |
| Sterile Rectal swab, PW1323 | 1 No. |
Details
Medium is provided in a polypropylene screw-capped tube with inbuild swab capture mechanism. Swab is provided in Sterile peel-open pouch. It is foam tipped, with red scored Break point. This molded breakpoint allows the swab to be broken in tube and gets captured* in vial containing transport medium.
- *If required, sterile forceps should be used to remove the swab from the vial or from the cap in case the swab is attached loosely to the screw cap.
Composition**
| Ingredients | Gms/Litre |
|---|---|
| Disodium phosphate | 1.100 |
| Sodium thioglycollate | 1.500 |
| Sodium chloride | 5.000 |
| Final pH (at 25°C) | 8.4±0.2 |
**Formula adjusted, standardized to suit performance parameters.
Directions for Use
Follow directions as given overleaf for collection of faecal specimens or clinical specimen using rectal swab. Specimens should be collected and processed as per the recommendations given in published protocols. Once a specimen is collected with a swab, it should be placed into the screw capped polypropylene tube containing the transport medium immediately and processed as soon as possible to achieve optimum recovery. In cases where immediate processing (i.e., within 2 hours) is not possible, specimens can be stored at 2-25 °C and processed within 48 hours.
Principle and Interpretation
Transport Medium is a non-nutritive, chemically defined, semisolid, buffered medium. The sole purpose of this medium is to maintain the viability of organisms during the time from collection to examination of the specimen. Transport Medium should be essentially non-nutritive so that the test organisms do not increase in numbers during transport. Transport media were originally formulated by Stuart et al (1) for carrying gonococcal specimens to the laboratory. Cary and Blair devised a new medium containing fewer nutrients, low oxidation-reduction potential and a high pH (2). Cary-Blair Medium w/o Charcoal is used for collection and transport of clinical specimens. It is also recommended by APHA (3) and various authors for transport of specimens (4,5,6). Since this transport media has a high pH, viability of Vibrio cultures can be maintained for a longer duration (7). This medium also facilitates the recovery of Salmonella and Shigella species (4). Cary-Blair Medium Base is prepared with minimal nutrients to facilitate survival of organisms without multiplication. Sodium thioglycollate provides a low oxidation-reduction potential. Alkaline pH of the medium minimizes bacterial destruction due to the formation of acid. Disodium phosphate buffers the medium whereas sodium chloride maintains the osmotic equilibrium.
Quality Control
Appearance: Sterile liquid Cary-Blair medium in tubes. Sterile swab for collection of specimen.
Colour: Clear to slightly opalescent colourless liquid medium in tubes.
Quantity of Medium: 2ml of medium in tubes
Reaction: 8.20-8.60
Cultural response: Viability of following organisms was established for a period of 48 hours. Organisms grew luxuriantly when recovered on Tryptone Soya Agar (M290) and incubated at 35-37°C for 18-24 hours.
Sterility test: Passes release criteria
Cultural Response
| Organism | Recovery |
|---|---|
| Enterobacter aerogenes ATCC 13048 | Good-Luxuriant |
| Escherichia coli ATCC 25922 | Good-Luxuriant |
| Klebsiella pneumoniae ATCC 13883 | Good-Luxuriant |
| Neisseria meningitidis ATCC 13090 | Good-Luxuriant |
| S. serotype Typhimurium ATCC 14028 | Good-Luxuriant |
| Shigella flexneri ATCC 12022 | Good-Luxuriant |
| Vibrio parahaemolyticus ATCC 11344 | Good-Luxuriant |
| Vibrio cholerae ATCC 15748 | Good-Luxuriant |
Specimen cultures in the laboratory:
Vortex or mix well by shaking the Swab in tube inside to release cells and create even suspension in the liquid medium. Being in suspended form, the specimen culture can be used for either of the following:
- Bacteriological culturing method using standard laboratory techniques for isolation and identification of bacteria.
- Remove the cap with swab applicator. Using the swab applicator, streak the first quadrant of the agar plate while rolling the swab tip to create a primary inoculum. If additional plates are required replace swab back into the tube for a few seconds to recharge the swab and repeat streaking. For recommended culture media and techniques for the isolation and identification of bacteria from clinical swab specimens refer to published microbiology manuals and guidelines.
- Direct microscopic examination of patient clinical samples.
- Processing specimens for molecular screening.
- Automated processing techniques
Storage and Shelf Life
Store between 5- 25°C with caps firmly screwed. DO NOT FREEZE. Avoid exposure to excessive heat. Use before expiry date on label
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 (7,8).
Type of Specimen
Feaces specimen, Rectal swabs for enteric organisms
Guideline For Specimen Collection
- Open the pouch from the side marked with the arrow Cut to open.
- Remove self-standing polypropylene screw capped tube from the pouch and the sterile swab.
- Observe aseptic techniques wherever applicable.
- Collect the specimen from the patient using sterile swab or insert swab into the faecal specimen sample already collected.
- Remove the cap and insert the swab into the in to the tube.
- Carefully break the swab by bending at the printed breakpoint line. Discard the broken handle part of the swab into biohazard labelled bag or follow appropriate precautions.
- Tighten the screw cap so as to secure the swab into the cap. Ensure to secure tightly.
- Record patient information in the space provided on the tube label. Transport the specimen to the laboratory for testing.
Figure 1: Illustration for use of MS2016B
- Open the peel pouch and remove the tube
- Place the swab with specimen in liquid transport medium
- Pouch has Tube & Swab for Specimen Collection
- Breaking the swab at breakpoint within the tube
- Swab has break point
- Swab Dipped in Transport Medium
- Rectum
- Specimen Collection using swab
- Capping the tube with swab
- Specimen ready for transport
Specimen Collection Instructions for Use
Clinical specimens are considered as biohazard. Wear appropriate protective clothing while collecting and handling potential infectious specimens. Care should be taken to avoid splashes and aerosols when breaking the swab handle into the tube containing medium. When collecting specimen with swab applicator, the area below the red colored printed breakpoint must not be touched.
Warning
- In Vitro diagnostic use only.
- Read the instructions before opening the container.
- Product should be handled by trained personnel and qualified person only or who has knowledge of microbiological lab practices.
- Safety guidelines may be referred to individual safety data sheets.
- Please read and follow the instructions in this package insert carefully and use appropriate aseptic techniques.
Precautions
- All clinical specimens should be considered biohazards and handled with care.
- Wear appropriate personal protective equipment.
- Follow good microbiological lab practices while handling specimens and culture.
- Standard precautions as per established guidelines should be followed while handling clinical specimens (7,8).
- It is suggested to also refer to the recommendations of the Centers for Disease Control and Prevention's Biosafety in Microbiological and Biomedical Laboratories for in vitro diagnostic use.
- Do not use the transport system beyond the expiration date printed on the label.
- Do not use if the sterile pouch seal is damaged.
- The foam tipped rectal swab provided in the pouch is scored at a specific point to allow for easy breakage after transferring the swab tip to the vial containing the transport medium. If by chance these are not held within grip feature of cap, sterile forceps may be necessary.
- Use caution when removing swab from tube.
- Sterilize the unit after use, and dispose of it according to biohazard waste disposal regulations.
- Do not ingest Liquid Cary Blair Medium.
Limitations
- HiMedias Liquid Cary Blair Medium Collection & Transport System is recommended for enteric organisms from faecal specimens.
- Extreme temperatures should be avoided during transportation of the collection system.
- The performance of the MS202A for storage time over 48 h has not been evaluated.
- Use of HiMedias Liquid Collection & Transport System in conjunction with other commercial rapid diagnostic kits and instruments must be validated prior to use by the user.
Performance and evaluation
The performance characteristics of HiMedia Liquid Collection & Transport System swabs are determined using the procedures outlined in the Clinical Laboratory Standards Institute (CLSI) M40-A2 document(9). A variety of aerobic, anaerobic, and fastidious organisms are tested in this study. Roll Plate methods and swab elution methods are conducted to perform bacterial viability studies. Acceptance criteria for recovery of bacteria as recommended in the CLSI document M40-A2 are followed. For Roll-Plate Method, the viability to be considered acceptable, there shall be > 5 CFU following the specified holding time from the specific dilution that yields zero-time plate counts closest to 300 CFU. For viability in the Swab Elution Method to be considered acceptable there shall be no more than a 3 log10 (1 x 10³ +/- 10%) decline in CFU between the zero-time CFU count and the CFU of the swabs that were stored. Performance of the product is expected when used as per the directions and organisms grown under recommended incubation conditions.
| Product Name | HiCulture™ Transport Swab w/Soyabean Casein Digest Medium w/6.5% NaCl |
|---|---|
| SKU | MS2016B |
| Customized Product Available | No |
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