The following section will outline the 5 important steps involved in submitting a quality sample for mycoplasma testing:
- Completion of the sample submission form
- Labeling of the sample
- Proper sample preparation
- Storage/transportation of sample
- Notification of Technical Service
Sample Submission Form
Enclose with sample(s) a completed copy of our Sample Submission Form
Proper identification of samples is extremely important. Clearly label each sample vessel. The identification number on the sample submission form must correspond exactly with the identification number on the sample submitted. This is required for compliance with Current Good Manufacturing Practices (cGMP) for Test/Catalog #: M-250, M-300, M-350, M-700, M-800, M-1400 and M-1450.
Note: Bionique® Testing Laboratories is a Biosafety Level 2 (BSL 2) facility and does not accept test materials that exceed BSL 2 handling and requirements. We do not accept test materials containing replication competent retroviruses including Human and Simian Immunodeficiency viruses (HIV and SIV), herpesviruses, in addition to BSL 3 or BSL 4 agents, and reserve the right to determine the acceptance of certain test materials. Please contact Technical Services to verify acceptance of your sample prior to shipping any sample containing human or animal viruses, potential pathogens or other biohazardous materials.
For more information on recommended biosafety levels for infectious agents, please refer to the CDC website: http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf.
Note: We offer a testing alternative for agents assigned to Biosafety 3 and 4 categories: our M-100 CELLshipper® Mycoplasma Detection Kit.
Bionique® Testing Laboratories recommends freezing samples without cryopreservatives and storing samples at ≤ - 60°C. In addition, cell culture samples should be cultured in antibiotic-free media for at least three passages prior to submission. Samples should be shipped overnight with sufficient dry ice to maintain sample integrity for optimal detection of mycoplasma. Cell culture samples may be submitted under ambient conditions for the M-150, M-175, M-250, M-300 and M-350 assays. However, shipping under ambient conditions may lead to sample compromise due to leakage, cell overgrowth, cell death and exposure to cyclic extremes in temperature.
Note: Not applicable to M-100 and M-175 CELLshipper® tests.
Refer to procedural summaries of each mycoplasma testing service (by catalog number) for complete instructions on sample preparation, minimum test volumes and shipping instructions related to the individual assays.
- Prepare your samples per specific test instructions found in the procedural summary. Remember the analytical accuracy of the test depends on the quality of your sample.
- Send sufficient volume of sample in an appropriately sized container for the test requested. Remember that the volume of aqueous solutions (e.g. media, cell cultures, sera, etc.) changes in relation to temperature and air pressure.
- Package your sample to maintain stable conditions and prevent breakage.
- Ambient shipments should be packaged to protect samples from leakage, freezing and/or overheating, crushing and/or impact. Samples must be received intact without evidence of leakage or other sample compromise in order to be accepted for testing.
- Frozen shipments should be packaged with sufficient dry ice to keep the enclosed samples frozen for a minimum period of two days. Samples shipped frozen must be received with sufficient amount of dry ice remaining to be accepted for testing.
Ship sample(s) next day courier service for receipt at Bionique® Testing laboratories, Monday - Friday, 8:00 am - 4:00 pm Standard Eastern Time. Holiday closings are listed on our Shipping Calendar.
Note: Refer to specific courier service guides to determine which guaranteed delivery services are provided to this location.
ATTN: Technical Services
Bionique® Testing Laboratories, Inc.
156 Fay Brook Drive
Saranac Lake, NY 12983
If you have any questions about sample preparation and/or shipping, please contact Technical Services at (518) 891-2356.
Notification of Sample Submission
We request that you contact us 2 business days in advance of shipping samples. Information can be forwarded either by faxing your sample submission form to (518) 891-5753 or e-mailing to firstname.lastname@example.org.
Bionique® Testing Laboratories offers mycoplasma testing services for quality control and research purposes only. These services are not to be used for clinical diagnosis.