A: As stated in the guidance, FDA believes that VTM distributed by commercial manufacturers under this policy should be designed and validated consistent with the Centers for Disease Control and Prevention's (CDC's) Standard Operating Procedure (SOP): Preparation of Viral Transport Media. The isolation count also increases when viral specimens are sent to either a local laboratory or a reference laboratory. It has a central carbon Food is a basic human need for the growth and development of our body. The policies in this guidance do not apply to transport media devices intended for viral inactivation, commonly referred to as inactivating transport media (ITM). 43 0 obj Ocular, respiratory, and tissue swabs can be submitted in this medium. endstream However, some other media can be prepared locally while maintaining suitable conditions and composition. She is particularly interested in studies regarding antibiotic resistance with a focus on drug discovery. Results showed that of the specimen transport reagents tested, PrimeStore MTM was one of just two such reagents from which no residual virus was detectable by either TCID50 or by the passaging of treated purified sample. DO NOT refrigerate. As discussed in section IV.D of the COVID-19 Transport Media Policy, 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. Tilt patient's head back 70 degrees. Ledden, David (SHS POC ST) According to the requirements of different manufacturers' products and testing environment. - Five common transport media (VTM, UTM, M4RT, Amies and saline) used to collect and transport nasopharyngeal (NP) swab specimens for laboratory detection of SARS-CoV-2 demonstrate comparable performance in two different rRT-PCR-based assays. 3 0 obj For a complete list and further options please see our Cookie Policy. This page provides answers to frequently asked questions relating to the development and use of transport media during the COVID-19 public health emergency. Transport of viral specimens. The BD universal viral transport (UVT) system is designed to transport viruses, chlamydiae, mycoplasmas and ureaplasmas at room temperature. As discussed above, to work safely with live human coronavirus SARS-CoV-2 requires the use of high-containment laboratories. CY-F005-20, CY-F005-20-NGS, CY-F005-20-NGSH, CY-F003-40, CY-F003-40-NGS, CY-F003-40-NGSH, Viral Transport Medium Tube with Swab, Item Code: 345TK2, KSL Virus Specimen Collection Kit 4 (Catalogue 52018), Guangzhou Improve Medical Instruments Co., Ltd, IMPROVIRAL Viral Preservative Medium (VPM), ViroDefender Virus Transport Medium (VDVTM), Universal COVID-19 Viral Transport Medium. no. Transport medium 199 is widely used for the collection and transport of clinical specimens from all species. Nasopharyngeal (NP) swabs also accepted in viral transport medium (discard OP swab included with viral transport medium), ESwab, or saline. After transportation, the specimen should be inoculated in the proper medium as soon as possible. While gently rotating the swab, insert Cepheid proactively developed Xpert Xpress CoV-2/Flu/RSV plus with several enhancements compared to Xpert Xpress SARS-CoV-2/Flu/RSV. Label the bottle along with the date of production, additives, and expiration date. There are even other names. Universal transport media may be used to transfer samples to laboratories for use in viral antigen detection test, PCR and rapid tests. PrimeStore MTM is also being used during the coronavirus pandemic by a number of businesses to provide COVID-19 testing services for their staff. BD Universal Viral Transport Vials For the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory Supplier: BD 220220 View more versions of this product Catalog No. UTM Universal Transport Medium 's unique media formulation includes antibiotics to inhibit bacterial and fungal growth, without affecting viruses. For optimum results, the time-lapse between sample collection and inoculum onto the culture medium should be reduced to the minimum. 1 0 obj 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. endobj BD Universal Viral Transport System is for single use only; reuse may cause a risk of infection and/or inaccurate results. HW]w}G>sXI>`nU3`{U(?O6v{>'l$Z$_Uter]sas f3OHe?b;fBpa/-;.w=6[\L5_oisA[?7_3.ya`>I"LXd]lR< MicroTest M4RT contains gelatin, gentamicin, and amphotericin B for the transport of viruses and Chlamydiae Patented formulations with stabilizing proteins, buffers, and specific antibiotics Provides compatible transport for cell culture, enzyme immunoassays, and molecular diagnostic tests Keep lids tightly closed after the medium is dispensed. This is enabling them to bring back those who may be self-isolating due to concerns over infection, or that of a family member. endobj Enzyme Furthermore, as samples are live, cold chain storage and transportation is required. 44 0 obj Commercial manufacturers of VTM should also include a statement that the device has been designed and validated consistent with CDC's SOP: Preparation of Viral Transport Media. The Impact of Universal Transport Media and Viral Transport Media Liquid Samples on a SARS-CoV-2 Rapid Antigen Test A viral transport media (VTM) is a nutrient substance used to carry and maintain the viability of specimens (viruses) to a laboratory for the identification and further processing of the sample. viral transport medium) 1 Attach catheter to suction apparatus. 51 0 obj The full name of UTM is universal transport media, which is literally translated as universal transport media. A selection of these references are available. Immediately destroy all Viral Transport Media Containers. The results were equivalent or superior to the media in the comparison. This table shows product codes for the different types of transport medium products that are referenced in the policies in the COVID-19 Transport Media Policy. 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. Collect and preserve virus, chlamydia, mycoplasma and other specimens. This medium can serve as a cryoprotectant for clinical viruses, including Cytomegalovirus and Varicella-zoster virus. No. Item Description: Copan Universal Transport Media (UTM-RT) Contains one transport container and two (2) standard sized swabs. The .gov means its official.Federal government websites often end in .gov or .mil. This means that it is ready for safe testing immediately on arrival at a laboratory and without need for containment. Commercially prepared viral transport media (VTM) are available in the market but VTM can also be prepared locally. This website uses cookies to improve your experience while you navigate through the website. 2023-03-04T05:18:35-08:00 The COVID-19 Transport Media Policy furtherrecommends that all transport media should be validated prior to use. 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. Submit the swab in Viral Transport Medium or Universal Transport Medium. 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. Provides protective protein and antibiotics to inhibit microbial contamination and buffers to control the pH balanced environment. Processing: BAL or BW Specimen MUST be received in Microbiology laboratory within 2 hours of receipt in the RRL. 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. Multiple peer-reviewed scientific papers have been published from 2011 onwards, validating the use of PrimeStore MTM for reliable pathogen deactivation (Table 2) and detection from a wide variety of clinical matrices and biofluid types, and with a range of analytical platforms. The key differences between MTM and generic UTM/VTM media are summarized in Table 1. For the collection and transport of specimens in animals, two types of VTMs can be utilized. 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. They also observed that, Moving to virus-inactivating VTM at collection allows risk mitigation from transportation and handling of bio-specimens for diagnosis and can potentially reduce the need for special packaging and transportation measures for SARS-CoV-2/COVID-19 test samples. [2]. Evaluate previous test results where this product was used and determine if patients should be re-tested. ** 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. %PDF-1.6 % Key enhancements include the addition of a third gene target for SARS-CoV-2 (RdRP now included in addition to E and N2), to be more robust against mutations. They noted that PrimeStore MTM has been extensively analysed to effectively inactivate/kill viral, bacterial and fungal pathogens while preserving stability of the released DNA and RNA for diagnosis, and is FDA cleared. Place swabs in viral transport medium (33595, 33625). The guidance further explains that manufacturers should have documentation demonstrating their compliance with ISO 13485 which should be sent to FDA as part of the manufacturer's notification. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Viral / Universal Transport Media and ESwabs; Sputum & Bronchoalveolar Lavage, Tracheal Aspirate; Viral / Universal Transport Media & ESwabs. Remove catheter while rotating it gently. Its clear that a strong testing programme is needed ready for flu season and a potential second wave of COVID-19 as thousands of people are going to start presenting with symptoms that could be flu or coronavirus. Convenient System with a Variety of Configurations, Sample Collection, Transport & Processing, Full Lab Automation & Artificial Intelligence, Available in individual transport tubes in bulk or as patient collection kits paired with a swab. The novel, patented sample collection device, PrimeStore MTM allows COVID-19 samples to be rapidly inactivated in the collection tube. 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. No. VTM-M4. The FDA will acknowledge receipt of this email via auto-reply. endobj Puritan's vials contain a universal transport liquid that suspends the cells until they are processed at the lab. Microsoft Word for Microsoft 365 Add 10g veal infusion broth and 2g bovine albumin fraction V to sterile distilled water (to 400 mL), Add 0.8mL gentamicin sulfate solution (50mg/mL) and 3.2 mL amphotericin B (250g/mL), Collecting, preserving and shipping specimens for the diagnosis of avian influenza A (H5N1) virus infection, Guide for field operations; World Health Organization (WHO). HOME PRODUCTS CASES COMPANY NEWS CONTACT, ADDRESS: C8-2-2, GUANGGU UNITED SCIENCE AND <>stream Once a swab or biofluid is added to PrimeStore MTM the user has a snapshot in time for that inactivated microbial sample. 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. Mix by inverting the bottle. A Universal Transport Medium (UTM) is a storage and transportation container designed to maintain the viability of clinical specimens. In 2021, viral transport media accounted for a revenue share of 46% in the global viral transport medium market and dominated other segments. eNAT is on label for use with Nasopharyngeal and anterior nasal swab samples. These tubes may contain antimicrobial agents to minimize bacterial and fungal contamination, as well as glass beads that assist in releasing and dispersing the sample into the medium during laboratory vortexing. UTM Universal Transport Medium for Collection, Transport, and Preservation of Clinical Specimens for Viral Molecular Diagnostic Testing. 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. throat swabs), sputum, saliva, and more can be stored in the reagent. /PRNewswire/ -- Universal Transport Medium (UTM) is an FDA-cleared collection and transport system suitable for collection, . More information on PrimeStore MTM novel virus transport media. Adenovirus, enterovirus, coxsackievirus A, cytomegalovirus (CMV), herpes simplex virus (HSV). Viral Transport Media (VTM) is used to transport the following specimens.Body SitesPotential VirusesSpecimen CollectionEyeAdenovirus, enterovirus, coxsackievirus A, cytomegalovirus (CMV), herpes simplex virus (HSV), varicella-zoster virus(VZV)Collect conjunctival swab on Dacron or rayon swab moistened with saline and place in VTM; aqueous and vitreous fluid placed in a sterile container without VTM.FecesAdenovirus, astrovirus, CMV, norovirus, rotavirusFecal specimens (preferred) in a leak-proof container; fecal swabs in VTMGenitalAdenovirus, CMV, HSV, papillomavirus, varicella-zoster virus(VZV)Collect on swabs and transport in VTMRespiratoryAdenovirus, coronavirus, hantavirus, CMV, HSV, influenza virus, parainfluenza virus, metapneumovirus, measles virus, rhinovirus, RSV, VZVNasopharyngeal aspirates (NPA) are specimens of choice from children, NPA or nasopharyngeal swabs collected from adults; bronchoalveolar lavage for the diagnosis of lower respiratory tract infections. A: Yes, section IV.D of the COVID-19 Transport Media Policy outlines policies applicable to laboratories certified under CLIA that meet the requirements to perform high-complexity testing. A: This table shows product codes for different types of transport medium products. uuid:90ed6ba5-1dd2-11b2-0a00-6a0000000000 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. Safe molecular transport media (MTM) ready for monkeypox and COVID-19 samples. MicroTest Tubes come with 1.5mL or 3mL of liquid medium in a 15mL conical tube with 3 glass beads. Viral culture. virus transport media or sample preservation solution is a liquid medium added to the sampling tube. Single Use Samplers manufactured after 15 October, 2020, Universal Transport Medium (UTM), Cat. MicroTest M4RT contains gelatin, gentamicin, and amphotericin B for the transport of viruses and Chlamydiae. In order to maximize the amount of virus in the specimen, the sample collection should be done early in the patients illness. Features. The guanidine thiocyanate contained in Primestore MTM destroys a viruss protective viral coat (the capsid) rendering it incapable of reinfection, whilst maintaining the viral nucleic acids for molecular diagnostics, sequencing and biobanking. 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 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. Successful and reliable isolations of viruses can be accomplished when a suitable transport medium is used. Add 0.8 ml gentamicin sulfate solution (50 mg/ml) and 3.2 ml amphotericin B (250 g/ml) . The transport medium comes in a plastic, screw cap tube and maintains organism viability for 48 hours at room or refrigerated temperature. Privacy | Terms & Conditions | Terms of Sale |UK Modern Slavery Act. Maximum ten (10) per order. Unlike most standard sample collection systems MTM removes cold chain requirements for sample collection and transportation, ensuring RNA stability at ambient temperatures. C7QX.R&OK2mb`]G/m=zytRYks~y&r3i?ho2L-I'H,lIn di.>a"r &apll,;b\bC%. In a dilution trial of a pure culture of spirochetes, transport media Al and A2 maintained the viability of 108 S. hyodysenteriae for 7 days; however, medium Al was 10-100-fold more effective than medium A2 when lower initial concentrations of spirochetes were sampled. Preserves viruses and chlamydiae for long-term frozen storage. This tube comes in a plastic screw cap and is suitable for the transport and preservation of a variety of medical specimens. PrimeStore MTM is seen as a real game changer for the sampling and transport of pathogenic samples from a safety, reliability and cost perspective. Some manufacturers, VTM is more targeted than UTM, specifically for the preservation and transportation of virus samples. A transport media is of three major types, viral transport media, universal transport media, and molecular transport media, with VTM being the most prominently used media at. It would be nontoxic to cell cultures and not obscure the appearance of viral cytopathic effects. This includes sterile VTM that have been designed and validated consistent with the current version of the CDC's SOP for the Preparation of Viral Transport Media as well as sterile phosphate buffered saline (PBS)/saline transport media. As discussed in the guidance, FDA does not intend to object to the distribution and use of PBS/saline transport media by commercial manufacturers, without compliance with the Unique Device Identification (UDI) requirements, when the manufacturer gives notification of validation to FDA. It is mandatory to procure user consent prior to running these cookies on your website. 16.Do not use for more than one patient. 2 mL Fill in 15 mL. <> The loosely packaged enveloped viruses obtained from human samples are generally more labile than the non-enveloped dense viruses. The transport medium comes in a plastic, screw cap tube and maintains organism viability for 48 hours at room or refrigerated temperature. A number of viral transport media are commercially available, which can directly be bought and used under the conditions mentioned. conventional transport media than in anaerobic and selective transport media. <>stream Do I need to manufacture my transport media under a quality system in accordance with 21 CFR Part 820? 50. 4. endobj Contact Information. We often see three types in the sampling tube label: UTM, MTM, and VTM. 3 Insert catheter into nostril. Sterilize by filtration and distribute in 1.02.0 ml volumes in screw-capped tubes. Note: Tube appearance may differ based on available supplies, but all will be labelled as Universal or Viral Transport Media, with an expiration date. The difference between UTM, MTM and VTM virus transportmedia. FlexTrans may also be used in rapid detection systems such as enzyme-linked immunosorbent assay (ELISA) and direct fluorescent testing. But opting out of some of these cookies may have an effect on your browsing experience. The global coronavirus (CoV) disease 2019 (COVID-19) pandemic has resulted in a worldwide shortage of viral transport media and raised questions about specimen stability. Orthopoxvirus (includes monkeypox virus) by PCR is a real-time polymerase chain reaction (PCR) test to detect the DNA of orthopoxviruses, including monkeypox. Of course, there are some differences in the composition of their preservation solutions. 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). This, in addition to the fact that refrigerated transport and storage is not required, can assist with disease differentiation at reduced costs when compared to standard collection kits. VTM and UTMs are designed for transporting samples intact for lab culture and contain components that inhibit optimal molecular testing, in comparison PrimeStore MTM was invented and optimised for molecular testing. 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. 2 . Additionally, FDA notes in the COVID-19 Transport Media Policy that it would be helpful to theFDA if manufacturers additionally provide information on their expected manufacturing capacity of their transport medium in their notification discussed above. [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] Viral Transport Media (VTM) Definition, Principle, Preparation, Application A viral transport medium (VTM) is an essential nutrient that is used to transport and sustain the viability of samples (viruses) to an laboratory for analysis and identification of the specimen. 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. 15.Do not use the Universal Viral Transport medium for premoistening or prewetting the applicator swab prior to collecting the sample or for rinsing or irrigating the sampling sites. Antibody antigen, COPYRIGHT: HUBEI NEW DE SHENG MATERIAL SCIENCE AND TECHNOLOGY CO., LTD., 4OO004, 4OO009, BioSci Disposable Virus Sampling Tube, SNT Biotech Disposable Virus Sampling Tube, Zhejiang Sorfa Life Sciences Research Co Ltd, Citoswab Collection and Transport Kit, P/N 2118-0419, Sample Preservation Solutions (LS-C-P-018). 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. This policy does not apply to compliance with other requirements and manufacturers are responsible for ensuring compliance with those requirements, including Registration and Listing requirements in 21 CFR Part 807, reports of corrections and removals in 21 CFR Part 806, medical device reporting under 21 CFR Part 803, and in vitro diagnostics (IVD) labeling requirements under 21 CFR Parts 801 and 809. 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. 3710-000, VACUETTE Virus Stabilization Tube, Item Number 456164, 456163, AMPICOLLECT Saline, NP Swab Kit, Catalog no. Tubes and Mattress Swab Sets. 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. VCM or equivalent = Viral-Chlamydial-Mycoplasma transport medium (green-cap) available from client supplies Chlamydia culture Swab (cervix, urethral, rectal, conjunctiva, vaginal): Do NOT use wooden or cotton swabs. 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. Blood collection tube additive The constituents of an appropriate viral transport media are selected to create an isotonic solution containing proteins to protect the viral structure, antibiotics to control microbial contamination, and one or more buffers to control the pH. Disperse the solutions to bottles and ca the bottles. Huachenyang (Shenzhen) Technology Co., Ltd. iClean Viral Transport System (VTM-RT), Catalog No. Adenovirus, enterovirus, HHV6, HHV8, HSV, Swab or aspirate fluid in vesicle and scrape cells at the base of the lesion; place fluid in VTM, Sustains viability for culture and nucleic acid amplification test (NAAT) of viruses, chlamydiae, mycoplasmas and ureaplasmas in a single formulation by preserving and stabilizing them.