The Biocomma® Transport and Preservation Medium is intended for the collection,storage, and transport of viruses, mycoplasma, chlamydiae or
ureaplasma specimens from the collection site to the testing laboratory.
Index of Symbols
Manufacture address: B1605-B1606, Life Science Park, Shenchengtou Creative Factory, Julongshan Rd, Xiuxin Community, Kengzi St, Pingshan Dist, ShenZhen, 518118, P.R.China
Customer service address: Ground FL, Bdg 12, Zhonghaixin Innovative Industrial Park, Ganli Six Rd, Buji St, Longgang Dist, Shenzhen, 518114, P.R.China
Manufacture record-filing number: 20200010
Medical device record-filing number/Product technical requirement number: 20200077
Specification approval date and revision date
Approval date: March 31, 2020
Revision date: May 7, 2020
Specification & Configuration
Required Materials But Not Provided
Materials required for isolation, extraction and culture of viruses, mycoplasma, chlamydiae and ureaplasma.
biocomma® Inactivated Transport and Preservation Medium is based on Hank's balanced salt solution enriched with inactivator and nucleic acid protective agents. It is used for nucleic acid extraction of samples such as viruses, mycoplasma, chlamydia and ureaplasma.
biocomma® Classic Transport and Preservation Medium is an upgrade from the Hank's solution. Additional various components, such as BSA, HEPES, amino acids, cryoprotectant, etc., are added to enhance the virus integrity. It can be used for nucleic acid extraction of virus,mycoplasma, chlamydia and ureaplasma samples and later virus isolation.
The pH of the preservation solution is 7.4 ± 0.5. The medium contains antibiotics and antimycotics for the purpose of inhabitation of bacteria and yeasts overgrowth. It helps to maintain the cellular integrity and preserve the viruses, mycoplasma, chlamydiae and ureaplasma.
biocomma® Transport and Preservation Medium is intended to be used with the medium tubes and swabs provided in the kit. The use of tubes of medium or swabs from any other source could affect the performance of the product.
Warnings & Precautions
1. Please read this instruction carefully before use.
2. biocomma® Transport and Preservation Medium should be used by trained and qualified personnel.
3. Do not use beyond expiration date. Do not use if the original seal of the medium and swab is damaged. Check the outer packaging of the product before use to make sure it is complete with no content overflow. The labeling is unbroken with clear content and no shedding. The preservation solution should be pre-loaded in the sampling tube. It is normal phenomenon to have precipitate at low temperature. biocomma® Inactivated Transport and Preservation Medium is a clear solution, do not use if the color of the medium turned turbid, or cloudy; biocomma® classic Transport and Preservation Medium is an orange-red color solution, do not use if the color of the medium has changed from light orange-red.
4. Avoid the medium in contact with eyes and skins.
5. Do not contaminate the tip of the swab before taking samples.
6. Be careful when the swab is inserted into the mouth for oral sampling. Avoid the risk of choking.
7. For single use only. Different patients are prohibited from using the same swab or tube.
8. Specimens for the search of viruses, mycoplasma, chlamydiae and ureaplasmas involves risk of infection, and must be collected and handed using proper PPE against biological risk according to published guidelines and local regulations.
9. Sample sites, condition, volume and timing of specimen collected are significant variables in obtaining reliable culture results. Follow recommended guidelines for specimen collection.
10. The use of this product in combination with diagnostic kits or instruments must be validated by the user prior to use.
Instructions for Use
Principles of the Procedure after Specimen Collection
When collect specimens with biocomma® Inactivated Transport and Preservation Medium, tube can
be transported to the laboratory at room temperature (5-25°C) within 7 days. It's better with ice bag.
Avoid repeated freeze-thaw cycles. For best performance, complete testing within 24 hours in
controlled temperature environment.
When collect specimens with biocomma® Classic Transport and Preservation Medium, tube can be transported to the laboratory at 2-8°C within 2 days. If it cannot be delivered to the laboratory within 48 hours, it should be stored at -70°C or below, and ensure that the collected specimens are delivered to the laboratory within 1 week. Avoid repeated freeze-thaw cycles. For best performance, complete testing within 24 hours.
Production Date / Expiration Date
The manufacture production date can be found on the package. Product validity period: 12 months.
For optimal performance, the product must be stored in its original package at 5-25°C until the time of use. Do not expose to excessive heat or direct sunlight prior to use.
Waste must be disposed of in compliance with local legislation. If necessary, take appropriate precautions for infected material.