PrimeStore® MTM
Self-contained, ready-to-use system that allows for the stabilization and safe transport of clinical samples at ambient temperature from the collection site to the laboratory.
Intended use
PrimeStore® Molecular Transport Medium (PS-MTM) is intended for stabilisation, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal swabs, and oral/throat swabs suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.
Specimen collection procedure
Non invasive collection of suitable clinical/biological samples including nasal washes and sputum samples. Collect clinical/biological specimens using standard clinical procedures.
1. Unscrew cap
Unscrew cap of the PS-MTM tube.
2. Collect sample
- For MTB sputum collection, swirl a submerged flocked swab five times in clinical sputum sample. The volume of sputum sample absorbed onto a flocked swab is typically 0.1 to 0.2 mL.
- Influenza specimens should be collected using a throat swab, NP swab, or nasal washing. Up to 0.5 mL of nasal wash can be added to each PS-MTM tube. A second sample should be collected if there is a requirement directed by protocol, state or federal law to submit samples to the United States Center for Disease Control (CDC).
3. Insert sample
If collection is by NP or oral swab, insert flocked swab containing collected sample directly into PS-MTM collection tube and break off excess swab handle at the indicated break point.
4. Close tightly
Place cap on PS-MTM tube and close tightly.
Store sample
Store at room temperature until ready to ship to a diagnostic laboratory. MTB DNA from samples collected and stored in PS-MTM is stable for up to 30 days at ambient temperature (10-26oC). Influenza A RNA from samples collected and stored in PS-MTM is stable for up to 7 days at ambient temperature (26oC) or can be refrigerated for up to 28 days.
Proceed with RNA/DNA extraction after letting the specimen sit in PS-MTM for a minimum of 60 minutes. Vortex sample before use. Extract the RNA/DNA using an extraction kit or an automated platform validated for use with PS-MTM.
Precautions
- To be used by trained and qualified professionals.
- Read the information in this package insert and follow directions carefully.
- Refer to the product Safety Data Sheet (SDS) for safe handling procedures.
- For specimen in PS-MTM follow state, local and institution guidelines for the handling and disposition of biohazard waste.
- Shelf life: 24 months from manufacture.
Do NOT:
- Do NOT mix with strong acids, alkalis, or oxidizing agents. Contact with acids liberates toxic gas.
- Do NOT insert swab into solution before collecting patient specimen.
- Do NOT drink, touch or remove PS-MTM from collection tube.
- Do NOT transfer PS-MTM into other tubes.
- Do NOT pool PS-MTM into larger volumes, or leave tubes uncapped for more than 10 minutes.
Limitations
- Performance characteristics of PS-MTM have been demonstrated for Influenza RNA and MTB DNA. The user is responsible for validating PS-MTM with all diagnostic assays to include those used in this submission.
- Performance characteristics of PS-MTM have been demonstrated for Influenza RNA from nasal washes and MTB DNA from sputum.
- The user is responsible for establishing appropriate system performance characteristics for other specimen types and tissues.
- The PS-MTM system is a collection, preservation, transport, and storage system for Influenza RNA and MTB DNA Extraction and purification of nucleic acids have been validated on several manual spin column kits (PrimeXtract™ RNAqueous Micro Kit, Viral RNA Mini Kit, QiaAMP DNA Mini Kit) and automated magnetic bead extraction kits (NucliSENSE EasyMAG and MagNA Pure 96 System using the DNA Bacterial/Viral small volume kit). The user is responsible for validating additional extraction and purification kits and platforms.
Reagents
Guanidine thiocyanate, TCEP, Sodium citrate, N-Lauroylsarcosine (NLS) sodium, Antifoam A, TRIS, EDTA, Ethanol (molecular grade), HCl, Nuclease-free water.
Test Accuracy
Accuracy of molecular testing depends on proper specimen collection, integrity of nucleic acid, extraction and PCR amplification.
To get a quote for the products or to place an order, please email Sales@2BScientific.com.