POWERD BY 300.CN E-NO.00000000-1. Universal Transport Medium for Viruses, Chlamydia, Mycoplasma and Ledden, David (SHS POC ST) Our Universal transport medium is CE marked transport system suitable for collection, transport, maintenance and long-term storage of clinical specimen containing wide range of pathological beings; including but not limited to COVID-19. Johnson, F. B. endobj A Universal Transport Medium (UTM) is a storage and transportation container designed to maintain the viability of clinical specimens. UTM Universal Transport Medium for Collection, Transport, and Preservation of Clinical Specimens for Viral Molecular Diagnostic Testing. Transport Tube (Small Volume Fluid, Aspirate or Tissue) UTM -Universal Transport Media (Viral, Chlamydia, Mycoplasma, Ureaplasma Culture, Bordetella pertussis) Viral Transport Medium. The transport medium comes in a plastic, screw cap tube and maintains organism viability for 48 hours at room or refrigerated temperature. Tubes and Mattress Swab Sets. 49 0 obj USP 32-NF 27<51>. Combined Nasal & Throat Swab 2 dry sterile polyester swabs (aluminum or plastic shafts preferred) Viral transport media tube (should contain 1-3 ML of sterile viral transport medium) 1 . p#r Microsoft Word for Microsoft 365 According to the requirements of different manufacturers' products and testing environment, Desheng can provide both preservation solutions. Viral Transport Media (VTM): Preparation, Uses Microbe Online PDF options: MicroTest M6 Multi-Microbe Media EN - Thermo Fisher Scientific TEL: 0711-37026501 8971041571 Most currently approved tests for COVID-19 (SARS-CoV-2 virus) and other infectious diseases are nucleic acid based molecular assays, so removing the need for and risk of live pathogen transportation for routine testing. Copan Universal Transport Medium (UTM) system is intended for the collection, transport, and preservation of clinical specimens containing Viruses, Chlamydia, Mycoplasma, and Ureaplasma. To 1 litre of above add: benzylpenicillin (2 x 10. There are already a number of published examples of its use in the workflow for SARS-CoV-2 RNA detection where it is used for initial virus inactivation [1]. C7QX.R&OK2mb`]G/m=zytRYks~y&r3i?ho2L-I'H,lIn di.>a"r &apll,;b\bC%. PDF The impact of viral transport media on PCR assay results for the Cepheid | Xpert-Xpress-CoV-2-Flu-RSV-Plus 12 0 obj The site is secure. endstream endobj 284 0 obj <>stream In order to maximize the amount of virus in the specimen, the sample collection should be done early in the patients illness. Adenovirus, coronavirus, hantavirus, CMV, HSV, Nasopharyngeal aspirates (NPA) are specimens of choice from children, NPA or. endobj Molecular Transport Media with Virus Inactivation - ZYMO RESEARCH FAX: 0711-3704589, COMPANY PROFILE In some parts of foreign countries, both VTM and UTM refer to the virus preservation solution. UTM, VTM, and Saline are on label. Use commercially inactivated FBS if available. Parafilm or tape the connection and lid of the sterile trap before transport. application/pdf Molecular Transport Medium Sales Analysis (2012 to 2021) Vs. Market Outlook (2022 to 2032) The global market for molecular transport mediums recorded a historic CAGR of 34.9% from 2012 to 2021.. Increasing sample transport during infectious disease outbreaks and the rising adoption of molecular transport mediums to transfer swabs to testing laboratories have resulted in market growth. This notification should include the name of the manufacturer, address, a contact person and e-mail address at which the contact person can be reached, the name(s) under which the product is sold or distributed, names of authorized importers and distributors, a copy of the instructions for use, and a statement and documentation that the device is manufactured in compliance with 21 CFR Part 820 or ISO 13485:2016 Medical Devices Quality Management Systems Requirements for Regulatory Purposes. <> A: Yes, section IV.C of the COVID-19 Transport Media Policy outlines policies for commercial manufacturers of sterile saline and PBS transport media. Use sterile swab to remove mucous or exudate and discard. Collectively these data showed that the commercial viral transport media contained nucleases or similar substances and may seriously compromise diagnostic and epidemiological investigations. Keep your lab moving in the right direction with a dependable set of solutions for transport, holding, maintenance and long-term . PrimeStore MTM is seen as a real game changer for the sampling and transport of pathogenic samples from a safety, reliability and cost perspective. f BDBPE14`LI0i "cml}SKSKPa3 !% However, modern molecular tests do not require viable virus, but just intact microbial nucleic acids. Commercially prepared viral transport media (VTM) are available in the market but VTM can also be prepared locally. Comparison of Universal Transport Media (UTM - COPAN Diagnostics Inc. These devices are generally exempt from premarket notification requirements under section 510(k) of the FD&C Act pursuant to 21 CFR 866.2300(b) (Class I Exempt). The global viral transport medium market is expected to 47 0 obj 3. Image Source: BD. Universal Viral Transport System. universal transport media vs viral transport media $ "xY1%GPl5'' ^ ~5 hqpF5aIsD KF.O- HW]w}G>sXI>`nU3`{U(?O6v{>'l$Z$_Uter]sas f3OHe?b;fBpa/-;.w=6[\L5_oisA[?7_3.ya`>I"LXd]lR< ** Generally, transport media consisting of certain types of viral transport media (VTM) would be regulated by these regulations, with the majority under 21 CFR 866.2390. 4 Begin gentle suction. Only one swab is required, however, if two swabs are used to sample the same source, the specimen is acceptable. <> The BD universal viral transport (UVT) system is designed to transport viruses, chlamydiae, mycoplasmas and ureaplasmas at room temperature. FDA does not expect laboratories to notify FDA if they plan to develop and use a transport media within the same corporate organization and common ownership by the same parent corporation. endobj Viral Transport Medium (VTM) is designed for hassle-free collection and transport of viral samples such as Covid-19, Swine flu etc. Always read the manufacturers package insert for specific instructions regarding specimen collection and transport for the type of test kit being used. While gently rotating the swab, insert Viral transport media are used for the collection and transport of specimens containing viruses. Viral Transport Media. The fact that it also enables laboratories to test for both COVID-19 and influenza from a single sample will also be greatly beneficial as the Flu season approaches. These cookies do not store any personal information. BB-2020, BB-2030, Viral Transport Medium, Catalog Number: VTM310, Viral Transport Medium, Catalog Number: V02, Transport and Preservation Medium, Model VTM-01. A: As discussed in the COVID-19 Transport Media Policy, the FDA does not intend to object to the distribution and use of viral transport media (VTM) devices or PBS/saline transport media devices where the manufacturer gives notification of validation of their transport media devices as outlined in the policy. PDF COMPARISON of UTM-RT and M4-RT TRANSPORT MEDIA for the ISOLATION of virus transport media or sample preservation solution is a liquid medium added to the sampling tube. UTM Viral Transport | COPAN Diagnostics Inc. 50. Taizhou Sun Trine Biotechnology Co., Ltd. Culture Media Concepts Sterile Normal Saline, 3 ML V468-3, Culture Media Concepts Sterile Phosphate Buffered Saline, 3 ML V591-3. Viral / Universal Transport Media and ESwabs; Sputum & Bronchoalveolar Lavage, Tracheal Aspirate; Viral / Universal Transport Media & ESwabs. Necessary cookies are absolutely essential for the website to function properly. M&1,h,LUTM~ }GI ]=O%|F? MicroTest Tubes come with 1.5mL or 3mL of liquid medium in a 15mL conical tube with 3 glass beads. OP or NP washes/aspirates in sterile cups. Designed and optimized for molecular applications, including qPCR and next generation sequencing, PrimeStore MTM uses a unique patented technology for safely collecting samples from patients with highly infectious diseases. UTM (3 mL) with mattress swab set (set contains one sterile wrapped regular size plastic shaft polyester swab and one Minitip plastic and stainless steel polyester applicator swab. Some growth of contaminants might be observed during the long period of transport. <> Features. Fluid samples such as tracheal wash specimens or peritoneal fluid should be submitted in sterile vials, preventing desiccation. The COVID-19 Transport Media Policy furtherrecommends that all transport media should be validated prior to use. In the case of COVID-19, this opens up options for more testing laboratories, making this device a key part of the testing supply chain which can underpin the safe and rapid increase of testing capacity. PDF MicroTest M4RT - Oxoid 51 0 obj R & D TEAM, Chemiluminescent reagent The composition and preparation of different viral transport differ depending on whether the sample is taken from humans or other animals. It provides a viral transport medium and a transport for the aforementioned organisms in one system. Transport medium 199 is widely used for the collection and transport of clinical specimens from all species. Please note that products in product code QBD are not within the scope of the COVID-19 Transport Media Policy. What Is a Universal Transport Medium? - IJEEM-News January 5, 2022 by Sagar Aryal Amies Transport Medium is an improved transport medium, containing charcoal to prolong the viability of pathogenic organisms. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. C_Restricted It is a semisolid media recommended for use in qualitative procedures for the transport of clinical swab specimens to the laboratory. PDF Specimen Lysis Tubes - Hologic VTM Kit - Polymed Medical Devices BD Universal Viral Transport Vials - Fisher Sci 5 Place specimen in sterile viral transport media tube. 17. Prepare the phosphate-buffer saline by adding 8 g of NaCl, 0.2 g of KCl, 1.44 g of Na2HPO4, and 0.24 g of KH2PO4. This medium can serve as a cryoprotectant for clinical viruses, including Cytomegalovirus and Varicella-zoster virus. Conclusion: Overall, Copan Universal Transport Media-UTM demonstrated comparable recovery to that of the Remel Micro Test-M4 media in the panel of infectious microorganisms tested. TheCOVID-19 Transport Media Policy explains that following completion of validation, notification that the commercial manufacturer intends to distribute the transport media should be provided to FDA by e-mail toCDRH-EUA-Templates@fda.hhs.gov that the transport medium has been validated. 1 0 obj endobj The .gov means its official.Federal government websites often end in .gov or .mil. Add 0.8 ml gentamicin sulfate solution (50 mg/ml) and 3.2 ml amphotericin B (250 g/ml) . Autoclave the prepared mixture and mix 1:1 with sterile glycerol to make 1 liter. MedSchenker Smart Transport Medium (STM) System is intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory. If nasopharyngeal (NP) swabs are needed, they must be ordered separately. <>stream The Viral transport medium contains Hank's Balanced Salt Solution with phenol red indicator to ensure media integrity at the time of specimen collection. Here VTM and UTM usually refer to non-inactivated preservation solutions. Universal Transport Medium UTM is an FDA cleared collection and transport system suitable for for collection, transport, and preservation of clinical specimens for viral molecular diagnostic testing, including COVID-19, chlamydia, mycoplasma or ureaplasma organisms. Liquid transport media are used primarily for transporting swabs or materials released into the medium from a collection swab. endobj Nasopharyngeal (NP) swabs also accepted in viral transport medium (discard OP swab included with viral transport medium), ESwab, or saline. Keep lids tightly closed after the medium is dispensed. Universal Viral Transport - BD 26055 Jefferson Avenue Murrieta, CA 92562, 2023 COPAN Diagnostics Inc. All Rights Reserved. The results were equivalent or superior to the media in the comparison. Provides protective protein and antibiotics to inhibit microbial contamination and buffers to control the pH balanced environment. TECHNOLOGY CITY, EZHOU CITY, HUBEI PROVINCE in Microbiology from St. Xavier's College, Kathmandu, Nepal. Orthopoxvirus/Monkeypox Infection Testing | ARUP Laboratories This information will help the Agency and Department monitor the landscape as we work to help ensure adequate testing supplies are available across the country during the COVID-19 public health emergency. These standard transport media may also contain enzymes and nucleases damaging to RNA and DNA, therefore inhibiting optimal molecular testing, such as PCR. Contact Information. endstream endobj 285 0 obj <>stream Remove catheter while rotating it gently. Part of the reason why the three names appear is due to different usage habits in different regions and translation problems. Hello, thank you for visiting my blog. viral transport media tube and cut off the applicator stick. What is the difference between UTM, MTM and VTM virus transport media Dispense 1.02.0 ml of transport medium into sterile plastic screw-cap vials. Q: I am having trouble obtaining viral transport media/universal transport media (VTM/UTM) and a flocked nasopharyngeal swab to collect and transport patient samples.Are there alternatives that I can use? Label the containers with the necessary information. It is a source of nutritional components, antioxidants, and essential oils, which benefit our health and promote the function of Microbeonline.com is an online guidebook on Microbiology, precisely speaking, Medical Microbiology. Coronavirus (COVID-19) and Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Coronavirus (COVID-19) and Medical Devices, Counterfeit At-Home OTC COVID-19 Diagnostic Tests, At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions, Blood Specimen Collection Tube Shortage: Frequently Asked Questions, Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers, Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDAs Response, Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19, Medical Device Supply Chain Notifications During the COVID-19 Pandemic, Medical Device Shortages During the COVID-19 Public Health Emergency, Supplies of Medical Devices for COVID-19: Frequently Asked Questions, Medical Device Types to Help Determine Section 506J Notification Obligations, Non-contact Temperature Assessment Devices During the COVID-19 Pandemic, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents, Contacts for Medical Devices During the COVID-19 Pandemic, FAQs on Viral Transport Media During COVID-19. Place swabs in viral transport medium (33595, 33625). PrimeStore MTM is a FDA cleared and CE IVD marked infectious disease sample collection, storage and transport system which was . These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify any existing policies. [107 0 R 108 0 R 109 0 R 110 0 R 111 0 R 112 0 R 113 0 R] Viral Transport Media Kits | Cardinal Health Cold chain storage and transportation required? The novel, patented sample collection device, PrimeStore MTM allows COVID-19 samples to be rapidly inactivated in the collection tube. Specimen Collection Practices for Microbiologic Culture - lab-best-practice To M4RT is intended for use as a collection and transport medium for viral and chlamydial agents only. However, after inactivation SARS-CoV-2 material can be handled at a lower containment level, thereby opening up testing capacity in more laboratories. Intended Use: The collection and transport of clinical specimens containing viruses, Chlamydiae, mycoplasma or ureaplasma from the . Disposable Sample Universal Transport Medium, Teknova Active Viral Transport Medium (ATM), HiViral Transport Medium, Product Code: AL167, HiViral Transport Kit, Product Code: MS2760, COVICHEK Clinical Viral Transport Medium (VTM), Model name: VTM-2M-OSA-T1-NSA-T1, Viral Transport Media (VTM) Kit, Cat. With millions of tubes already sold globally during and prior to the COVID-19 pandemic to hospitals and laboratories, it is evident that they trust that it provides safer and more reliable testing than generic VTM or universal transport media, saline, or RUO devices. Viral Transport Medium. So, samples in MTM do not have to be pre-processed in BLS-III or even BLS-II safety levels, just safe normal laboratory practices for testing are required. Anupama Sapkota has a bachelors degree (B.Sc.) Add 50mL of amphotericin B, add 50mL of gentamicin to the inactivate FBS and then filter sterilize the solution through a 0.20 to 0.45 m filter unit (150mL filter unit). DO NOT refrigerate. Viral transport media are prepared with the idea of sustaining the viability of the viral culture or specimens for tests like the nucleic acid amplification test (NAAT) while preventing the drying of the sample. MTM is specifically designed to safely inactivate pathogenic samples while preserving and stably releasing DNA and RNA. Recently, a consortium of researchers put forward the case for biosafety in pathogen transportation and testing through the adoption of virus-inactivating VTM which kill biological pathogens whilst ensuring DNA and RNA stabilisation and preservation for molecular applications. For the detection of new coronavirus samples, the molecule here refers to nucleic acid RNA. Blood collection tube additive After transportation, the specimen should be inoculated in the proper medium as soon as possible. The FDA will acknowledge receipt of this email via auto-reply. Orthopoxvirus (includes monkeypox virus) by PCR is a real-time polymerase chain reaction (PCR) test to detect the DNA of orthopoxviruses, including monkeypox. Viral transport media that is suitable for influenza specimens: M4, M4-RT, M5, M5-RT, M6, UTM, BD Universal Transport Media (UVT), Puritan UniTranz media, Quest VCM (green lid), Starplex Multitrans System, Hardy Diagnostics VTM, transport media manufactured or aliquoted in the ARUP Reagent Laboratory. Necessary Cookies are required for the normal function of this website. The full name of UTM is universal transport media, which is literally translated as universal transport media. Transport Media Market Expected to Grow USD 4,014.88 Million by 2028 As discussed above, to work safely with live human coronavirus SARS-CoV-2 requires the use of high-containment laboratories. UTM is an FDA cleared collection and transport system suitable for for collection, transport, and preservation of clinical specimens for viral molecular diagnostic testing, including COVID-19, chlamydia, mycoplasma or ureaplasma organisms. 50 0 obj In the virus sampling tube, it refers to the virus transportmedia. endobj Antibiotics are usually incorporated in viral transport media to suppress the growth of contaminating bacteria and fungi, so separate specimens from the same site must be collected if bacterial or fungal cultures are also requested. * Generally, transport media consisting of PBS/saline would be regulated by this regulation. This website uses cookies to improve your experience while you navigate through the website. <> Materials Provided Available Products Materials Required but not Provided 2023-03-04T05:18:35-08:00 By clicking Accept, you consent to the use of ALL the cookies. It is mandatory to procure user consent prior to running these cookies on your website. 22-031-14 $306.00 / Pack of 50 Qty Check Availability Add to cart Includes: Do I need to manufacture my transport media under a quality system in accordance with 21 CFR Part 820? A second medium, PBS-Glycerol transport medium, which is the glycerol-based medium, provides longer-term stability of specimens where cooling is not immediately possible. For the collection and transport of specimens in animals, two types of VTMs can be utilized. *** Generally, transport media consisting of certain types of inactivating transport media (ITM) would be regulated by this regulation. Molecular Transport Medium Market endstream endobj 286 0 obj <>stream These do not inactivate microbes and can also inhibit molecular testing. Is there any difference between these types of preservation solutions? Although VTM or UTM cannot inactivate the virus, it can be used for virus surface antigen or antibody detection in addition to nucleic acid detection because it preserves the integrity of the virus. These cookies will be stored in your browser only with your consent. No. Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. Evaluation of transport media for laboratory detection of SARSCoV2 in This is because samples collected and stored in MTM can be tested for both COVID-19 and influenza from a single swab sample that has been inactivated and stabilised. Learn how your comment data is processed. Viral transport media is fluid used in a specimen collection tube to keep any viral organisms viable during the tube's transport to a laboratory for testing. It would be nontoxic to cell cultures and not obscure the appearance of viral cytopathic effects. As an asst. Privacy Policy. professor, I am teaching microbiology and immunology to medical and nursing students at PAHS, Nepal. Kit Size / Case Size. Although VTM or UTM cannot inactivate the virus, it can be used for virus surface antigen or antibody detection in addition to nucleic acid detection because it preserves the integrity of the virus. MicroTest M4RT contains gelatin, gentamicin, and amphotericin B for the transport of viruses and Chlamydiae. Of course, there are some differences in the composition of their preservation solutions. 41116157. endstream endobj 283 0 obj <>stream ENZ-GEN244, Disposable Virus Specimen Collection Tube, Normal Saline, 0.9% normal saline in self standing tube, Product code TL1158, Normal Saline, 0.85% normal saline in self standing tube, Product code TL1159, Phosphate Buffered Saline, pH 7.2, 1x, Product code TL1031, Saline 0.85% 3ml, Part Number: T-0627, T-0627Ga. The main difference between MTM and VTM is that molecular transport media, such as PrimeStore MTM, will fully deactivate viruses, bacteria, fungi and mycobacterium tuberculosis, allowing safe sample handling and transport to greatly reduce infection risk. Copan has their international headquarters in Brescia, Italy, but also has a branch in Murrieta, Ca and a manufacturing plant in Carlsbad, Ca, where they produce FDA-Approved Transport Media. The loosely packaged enveloped viruses obtained from human samples are generally more labile than the non-enveloped dense viruses. Laboratories seeking to distribute transport media to entities that are not within the same corporate organization and that share common ownership by the same parent corporation should refer to section IV.B or section IV.C of the COVID-19 Transport Media Policy. Collect bronchoalveolar lavage and specimens from normally sterile sites in a sterile, leak-proof container (37777). The policies in this guidance do not apply to transport media devices intended for viral inactivation, commonly referred to as inactivating transport media (ITM). h241U0P041S0R It is suitable for egg inoculation but not suited for tissue culture inoculation. Another key benefit of MTM is that a sample can be safely stored at ambient temperature for up to seven days(Figure 1) or 28 days at 2 to 8C and re-used several times. [86 0 R 87 0 R 351 0 R 352 0 R 353 0 R 354 0 R 355 0 R 356 0 R 357 0 R 358 0 R 359 0 R 360 0 R 361 0 R 362 0 R 363 0 R 364 0 R 365 0 R 366 0 R 367 0 R 368 0 R 369 0 R 370 0 R 371 0 R 372 0 R 373 0 R 374 0 R 375 0 R 376 0 R 377 0 R 378 0 R 379 0 R 380 0 R 381 0 R 382 0 R 383 0 R 384 0 R 385 0 R 386 0 R 387 0 R 388 0 R 389 0 R 390 0 R 391 0 R 392 0 R 393 0 R 394 0 R 395 0 R 396 0 R 397 0 R 398 0 R 399 0 R 400 0 R 401 0 R 402 0 R 403 0 R 404 0 R 405 0 R 406 0 R 407 0 R 408 0 R 409 0 R 410 0 R 411 0 R 412 0 R 413 0 R 414 0 R 415 0 R 416 0 R 417 0 R 418 0 R 419 0 R 420 0 R 421 0 R 422 0 R 423 0 R 424 0 R 89 0 R 90 0 R 425 0 R 426 0 R 427 0 R 428 0 R 429 0 R 430 0 R 431 0 R 432 0 R 433 0 R 434 0 R 435 0 R 436 0 R 437 0 R 438 0 R 439 0 R 440 0 R 441 0 R 442 0 R 443 0 R 444 0 R 445 0 R 446 0 R 447 0 R 448 0 R 449 0 R 450 0 R 451 0 R 452 0 R 453 0 R 454 0 R 455 0 R 456 0 R 457 0 R 458 0 R 459 0 R 460 0 R 461 0 R 462 0 R 463 0 R 464 0 R 465 0 R 466 0 R 467 0 R 468 0 R 469 0 R 470 0 R 471 0 R 472 0 R 473 0 R 474 0 R 475 0 R 476 0 R 477 0 R 478 0 R 479 0 R 480 0 R 481 0 R 482 0 R 483 0 R 484 0 R 485 0 R 486 0 R 487 0 R 488 0 R 489 0 R 490 0 R 491 0 R 492 0 R 493 0 R 494 0 R 495 0 R 496 0 R 497 0 R 498 0 R 92 0 R 93 0 R] 5 0 obj The transport medium comes in a plastic, screw cap tube and maintains organism viability for 48 hours at room or refrigerated temperature. M6 transport medium was compared to commercial and standard transport media routinely used for the transport and maintenance of viral, Chlamydia, Ureaplasma, and Mycoplasma agents. Refer to the applicable assay package insert for appropriate Specimen Lysis Tubes and specimen types available for use with each assay. Made with by Sagar Aryal. Processing: BAL or BW Specimen MUST be received in Microbiology laboratory within 2 hours of receipt in the RRL. 2 mL Fill in 15 mL. Skirted, flat-bottom tubes with distinctive internal conical shape enable easy centrifugation of samples and allows the tubes to stand upright on the laboratory bench. We often see three types in the sampling tube label: UTM, MTM, and VTM. It is one of the only systems that may be stored and transported at 2C to 25Call in one formulation. Type. VTM-M4RT. COVID-19 Specimen Transport Media and Swabs for Test Code 7305. . Universal transport media may be used to transfer samples to laboratories for use in viral antigen detection test, PCR and rapid tests. Generally, transport media may contain different components to serve the function of stabilizing viruses, and FDA understands that some commercial manufacturers may wish to design and validate VTM formulations that may differ from the CDC's SOP for the Preparation of Viral Transport Media. We are trying our best to make this site user-friendly and resourceful with timely/updated information about each pathogen, disease caused by them, pathogenesis, and laboratory diagnosis. The difference between molecular and viral transport media - SelectScience As multiple infectious disease tests can be processed from one sample swab, this makes PrimeStore MTM ideal for the approaching flu season. A: Yes, transport media are required to comply with all requirements, including 21 CFR Part 820; however, as discussed in the COVID-19 Transport Media Policy, in order to help increase availability of commercially manufactured transport media, FDA does not intend to enforce the Quality System Requirements under 21 CFR Part 820 when commercial manufacturers of VTM or sterile PBS/saline transport media within the scope of the guidance conform to ISO 13485:2016 Medical Devices Quality Management Systems Requirements for Regulatory Purposes.