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. 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. 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. Fungal blood cultures. Viral Transport Medium. 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. A: This table shows product codes for different types of transport medium products. After transportation, the specimen should be inoculated in the proper medium as soon as possible. Product name Disposable Collection & Transport Kits (Inactivated) Product description 1.Specifications 10ml/tube and one collection Swab; Pkg of 1,Pkg of 10,Pkg of 20, Pkg of 50, Pkg of 100, Pkg of 200, Pkg of 300, Pkg of 500. POWERD BY 300.CN E-NO.00000000-1. 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. 3. 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. Suppresses bacterial and fungal contamination by incorporating antibiotics in the medium. 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. /PRNewswire/ -- Universal Transport Medium (UTM) is an FDA-cleared collection and transport system suitable for collection, . In addition to removing the need for expensive cold chain transport and storage of samples, RNA and DNA are perfectly preserved by PrimeStore MTM for up to four weeks. These cookies will be stored in your browser only with your consent. This category only includes cookies that ensures basic functionalities and security features of the website. The policies in this guidance do not apply to transport media devices intended for viral inactivation, commonly referred to as inactivating transport media (ITM). Tubes and Mattress Swab Sets. 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. 4.3mL of Roche Cobas PCR Media i-Clean narrow-tipped flocked swab (80mm breakpoint) Media Type: Guanidine/ Guanidinium-based**. The Viral transport medium contains Hank's Balanced Salt Solution with phenol red indicator to ensure media integrity at the time of specimen collection. Remove catheter while rotating it gently. No. Label the containers with the necessary information. Q(wz3[09JW0:O1Ahf6M@mj6Mw&/+U]!m.q^3!#dCk+}#;xXj?090'G9F7FZ}^8vRau[Z`i}$mc&bpvYF 5j`JnmghTz^90. Keep lids tightly closed after the medium is dispensed. 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. 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. The transport medium comes in a plastic, screw cap tube and maintains organism viability for 48 hours at room or refrigerated temperature. 2023-03-04T05:18:35-08:00 Preserve your cell samples in Puritan universal transport medium vials from Harmony Lab & Safety Supplies. 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. The probability of successful isolation increases when the time interval between collection and inoculation of the culture is less and when the specimen contains as many virus particles as possible. 52 0 obj Provides protective protein and antibiotics to inhibit microbial contamination and buffers to control the pH balanced environment. These cookies do not store any personal information. Viral Culture and for Molecular-Based Assays. 2 Tilt patient's head back 70 degrees. In addition, on-label transport media options now . This designed for the transport of viruses for research and testing purposes. Enzyme 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. 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. while maintaining their viability and stability. Mix by inverting the bottle. Product Name: Swab, UTM (Universal Transport Medium), and VCM (Viruses-Chlamydiae-Mycoplasmas Medium) Sets Catalog #: Refer to Section 16 for a list of applicable catalog numbers for items covered by this SDS. Huachenyang (Shenzhen) Technology Co., Ltd. iClean Viral Transport System (VTM-RT), Catalog No. 50 0 obj 55 0 obj 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. 48 0 obj If nasopharyngeal (NP) swabs are needed, they must be ordered separately. endobj Enabling Analytical Cookies provides information that helps us to improve the website, Tracking Cookies allow us to understand your flow and interaction through the website so we can make improve navigation, Enabling Social Cookies turns on Social Sharing buttons throughout the site. Some manufacturers, VTM is more targeted than UTM, specifically for the preservation and transportation of virus samples. endobj The infectivity of viruses decreases over time, and generally, the decay rate is a function of temperature, so that stability is enhanced by cooling. UTM Universal Transport Medium is an FDA-cleared collection and transport system suitable for the collection, transport, preservation, and long-term freeze storage of clinical specimens containing viruses for viral molecular diagnostic testing, including COVID-19, chlamydia, mycoplasma or ureaplasma organisms. As an asst. 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. A: As explained in the COVID-19 Transport Media Policy, only VTM devices labeled as sterile should be used in the transport of clinical specimens to avoid introducing microbial contamination in to the specimen. 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. [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] Materials Provided Available Products Materials Required but not Provided 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. Use Dacron/polyester swabs, fully immersed in medium. Alternative fluids that are readily available in hospital settings can function as alternatives to Viral Transport Media. Collectively these data showed that the commercial viral transport media contained nucleases or similar substances and may seriously compromise diagnostic and epidemiological investigations. Type. Swabs are transported in VTM.SkinAdenovirus, enterovirus, HHV6, HHV8, HSV, measles virus, parvovirus B19, poxvirus, rubella virus, VZVSwab or aspirate fluid in vesicle and scrape cells at the base of the lesion; place fluid in VTMTissueAdenovirus, CMV, HSV, other virusesPlace in VTM. Place swabs in viral transport medium (33595, 33625). Commercial manufacturers that wish to discuss an alternative formulation or validation approach should email CDRH-EUA-Templates@fda.hhs.gov. 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). [94 0 R 681 0 R 682 0 R 683 0 R 684 0 R 685 0 R 686 0 R 687 0 R 688 0 R 689 0 R 690 0 R 96 0 R 97 0 R 98 0 R 691 0 R 692 0 R 693 0 R 694 0 R 695 0 R 696 0 R 697 0 R 698 0 R 699 0 R 700 0 R 701 0 R 702 0 R 703 0 R 704 0 R 705 0 R 706 0 R 707 0 R 708 0 R 100 0 R 101 0 R 102 0 R 709 0 R 710 0 R 711 0 R 712 0 R 713 0 R 714 0 R 715 0 R 716 0 R 717 0 R 718 0 R 719 0 R 720 0 R 721 0 R 722 0 R 723 0 R 724 0 R 725 0 R 726 0 R 727 0 R 728 0 R 729 0 R 730 0 R 731 0 R 732 0 R 733 0 R 734 0 R 735 0 R 736 0 R 737 0 R 104 0 R 105 0 R 106 0 R] Adenovirus, coronavirus, hantavirus, CMV, HSV, Nasopharyngeal aspirates (NPA) are specimens of choice from children, NPA or. Liquid transport media are used primarily for transporting swabs or materials released into the medium from a collection swab. This medium can serve as a cryoprotectant for clinical viruses, including Cytomegalovirus and Varicella-zoster virus. As discussed in the guidance, FDA does not intend to object to the distribution and use of VTM by commercial manufacturers, without a 510(k) and without compliance with the Unique Device Identification (UDI) requirements, where the VTM device is validated, notification of validation is provided to FDA, and certain labeling information is included with the VTM device. MTM refers to the inactivated virus preservation solution, which is suitable for the collection, storage and transportation of infectious disease samples. This website uses cookies to improve your experience while you navigate through the website. Adenovirus was stable in all media and at both temperatures tested. 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. USP 32-NF 27<51>. UTM-RT (Universal Transport Media - Room Temperature) (Copan Diagnostics Inc.) Collection and Transport system for viruses, chlamydiae, mycoplasma and ureaplasma at RT Provided as stand alone medium tubes and Nylon ocked plastic shaft pernasal swabs in peel pouches or as collection kits with medium tube combined with Nylon Viral culture. Microbial Culture Media- Definition, Types, Examples, Uses, Types of Centrifuge and Centrifugation (definition, principle, uses), Amazing 27 Things Under The Microscope With Diagrams, 22 Types of Spectroscopy with Definition, Principle, Steps, Uses, Bacteria- Definition, Structure, Shapes, Sizes, Classification, Composition of Viral Transport Media (VTM), Preparation of Viral Transport Media (VTM), Preparation of PBS-Glycerol transport medium, Limitations of Viral Transport Media (VTM), https://www.who.int/ihr/publications/Annex8.pdf?ua=1, https://www.cdc.gov/coronavirus/2019-ncov/downloads/Viral-Transport-Medium.pdf, OF Test- Oxidation/Oxidative-Fermentation/Fermentative Test, Novobiocin Susceptibility Test- Principle, Procedure, Results, Nitrate Reduction Test- Principle, Procedure, Types, Results, Uses, Nosocomial Infections (hospital-acquired infections), Hot Air Oven- Principle, Parts, Types, Uses, Examples. There is also a kind called MTM, the full name is molecular transport media, which is literally translated as molecular transport media. 5 Place specimen in sterile viral transport media tube. BD UVT. <> PrimeStore MTM is seen as a real game changer for the sampling and transport of pathogenic samples from a safety, reliability and cost perspective. endobj %PDF-1.7 % 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. These do not inactivate microbes and can also inhibit molecular testing. VTM-M4. A suitable VTM for use in collecting throat and nasal swabs from human patients is prepared as follows: After sample collection, VTM can be stored at 2-25 C and processed within 48 hours. UNSPSC Code. The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute VTM as set forth in Section IV.B of the FDA's COVID-19 Transport Media Policy. The BD universal viral transport system is designed to transmit viruses and chlamydiae at room temperature. The policies outlined in the COVID-19 Transport Media Policy only apply to transport media that are intended to sustain the viability of viruses/other organisms and therefore, do not contain substances such as guanidinium/guanidine or similar chemicals intended to inactivate viruses. endobj This tube comes in a plastic screw cap and is suitable for the transport and preservation of a variety of medical specimens. f BDBPE14`LI0i "cml}SKSKPa3 !% 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. A: Yes, section IV.B of the COVID-19 Transport Media Policy discusses policies specific to commercial manufacturers of certain types of viral transport media that are class I (reserved) and subject to premarket notification requirements under section 510(k) of the FD&C Act. endobj Collect and preserve virus, chlamydia, mycoplasma and other specimens. endstream endobj 283 0 obj <>stream Successful and reliable isolations of viruses can be accomplished when a suitable transport medium is used. There are even other names. This page provides answers to frequently asked questions relating to the development and use of transport media during the COVID-19 public health emergency. 2023-03-04T05:18:35-08:00 Add 10g veal infusion broth and 2g bovine albumin fraction V to sterile distilled water (to 400 ml). Adenovirus, enterovirus, coxsackievirus A, cytomegalovirus (CMV), herpes simplex virus (HSV). 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 Please check availability. Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. No. Please note that products in product code QBD are not within the scope of the COVID-19 Transport Media Policy. 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]. January 5, 2022 by Sagar Aryal Amies Transport Medium is an improved transport medium, containing charcoal to prolong the viability of pathogenic organisms. Single Use Samplers manufactured after 15 October, 2020, Universal Transport Medium (UTM), Cat. Because they are labile to the environmental conditions, the viability of these viruses must be protected by using different solutions. +Qfd,?=-&)Fz^ E5#D Testing can take place outside of containment, No. [114 0 R 115 0 R 116 0 R 820 0 R 821 0 R 822 0 R 118 0 R 119 0 R 120 0 R 121 0 R 823 0 R 824 0 R 825 0 R 123 0 R 826 0 R 827 0 R 828 0 R 125 0 R 126 0 R 126 0 R 127 0 R 127 0 R 128 0 R 129 0 R 130 0 R] Thus, viral transport media are prepared with the idea of providing appropriate conditions of temperature, pH, and nutrients. 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. UTM, Universal Transport Medium, is a room temperature stable viral transport medium for collection, transport, maintenance and long term freezer storage of Viruses, such as Influenza H1N1, Chlamydia, Mycoplasma and Ureaplasma specimens. Shenzhen Dakewe Bioengineering Co., Ltd. BioSci Sterile Normal Saline, 0.85%, SNT Biotech Sterile Normal Saline, 0.85%, BioSci Sterile Phosphate Buffered Saline, Phosphate Buffered Saline (PBS) (600-108), PBS Response Sample Kit, Cat. [77 0 R 131 0 R 132 0 R 133 0 R 134 0 R 135 0 R 136 0 R 137 0 R 138 0 R 139 0 R 140 0 R 141 0 R 142 0 R 143 0 R 144 0 R 145 0 R 146 0 R 147 0 R 148 0 R 149 0 R 150 0 R 151 0 R 152 0 R 153 0 R 154 0 R 155 0 R 156 0 R 157 0 R 158 0 R 159 0 R 160 0 R 161 0 R 162 0 R 163 0 R 164 0 R 165 0 R 166 0 R 167 0 R 168 0 R 169 0 R 170 0 R 171 0 R 172 0 R 173 0 R 174 0 R 175 0 R 176 0 R 177 0 R 178 0 R 179 0 R 180 0 R 181 0 R 182 0 R 79 0 R 80 0 R 81 0 R 82 0 R 183 0 R 184 0 R 185 0 R 186 0 R 187 0 R 188 0 R 189 0 R 190 0 R 191 0 R 192 0 R 193 0 R 194 0 R 195 0 R 196 0 R 197 0 R 198 0 R 199 0 R 200 0 R 201 0 R 202 0 R 203 0 R 204 0 R 205 0 R 206 0 R 207 0 R 208 0 R 209 0 R 210 0 R 211 0 R 212 0 R 213 0 R 214 0 R 215 0 R 216 0 R 217 0 R 218 0 R 219 0 R 220 0 R 221 0 R 222 0 R 223 0 R 224 0 R 225 0 R 226 0 R 227 0 R 84 0 R 85 0 R] These cookies can be disabled in the browser settings. Kit Size / Case Size. endobj 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. 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. <> Note: Tube appearance may differ based on available supplies, but all will be labelled as Universal or Viral Transport Media, with an expiration date. By clicking Accept, you consent to the use of ALL the cookies. It provides a viral transport medium and a transport for the aforementioned organisms in one system. HW]w}G>sXI>`nU3`{U(?O6v{>'l$Z$_Uter]sas f3OHe?b;fBpa/-;.w=6[\L5_oisA[?7_3.ya`>I"LXd]lR< This immediately eliminates infection risk and also preserves nucleic acids for downstream molecular processing without need for refrigeration. )786h+AY8a+EwlI$vqgDgZ(fHKcY-' Af8"J@G&"%0wHssa~#osx yAHRD[ky byClt@b!C41F;HEW3=/lZ_~wu]L^NjH?WZ_Ue=^,'(E5g%F>oyI}>N+DrAC} 7F&$ fuzX!Zok>o/bY[A In vitro diagnostic reagent 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. no. It is a semisolid media recommended for use in qualitative procedures for the transport of clinical swab specimens to the laboratory. Commercially prepared VTM is available in a plastic screw cap tube that contains buffered protein (serum, albumins, or gelatin) and antibiotics. professor, I am teaching microbiology and immunology to medical and nursing students at PAHS, Nepal. A: As described in section IV.C of the FDA's COVID-19 Transport Media Policy, the FDA does not intend to object to the distribution and use of sterile PBS/saline transport media by commercial manufacturers, without compliance with the Unique Device Identification (UDI) requirements, where the manufacturer gives notification of validation to FDA. The universal transport media segment accounted for 34 . This medium does not need to be refrigerated or transported on ice and is suitable for storing and analyzing samples of various sizes. Collection Kit (Catalogue #) Roche media paired with i-Clean swab (06466281190 + CY-96000) Description. Sonic VTM. FAX: 0711-3704589, COMPANY PROFILE Use commercially inactivated FBS if available. TECHNOLOGY CITY, EZHOU CITY, HUBEI PROVINCE hTA0tf!B8Cl/1M6# QxIQB]6wJD[Q.+V' |H(gCzg'o5b%a}qv:@2~zN#5[ 0 17. A recent study by Public Health England [3]investigated a wide array of apparent inactivation reagents in current use in UK laboratories during the COVID-19 pandemic for sample transportation and subsequent molecular processing. endobj Sterilize by filtration and distribute in 1.02.0 ml volumes in screw-capped tubes. *** Generally, transport media consisting of certain types of inactivating transport media (ITM) would be regulated by this regulation. Biological buffer Nasopharyngeal (NP) swabs also accepted in viral transport medium (discard OP swab included with viral transport medium), ESwab, or saline. No. VTMs also help to maximize the number of viral particles in a sample. The percentage of recovery for each agent when stored at 2-8C was as follows: Use sterile swab to remove mucous or exudate and discard. R & D TEAM, Chemiluminescent reagent Viral Transport Media (VTM) are suitable for collection, transport, maintenance, and long-term freeze storage of clinical specimens containing viruses, chlamydia, mycoplasma, or ureaplasma organisms. 2 0 obj 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. Viral Transport Media. endobj COVID-19 and/or other respiratory viruses. For the detection of new coronavirus samples, the molecule here refers to nucleic acid RNA. Do I need to manufacture my transport media under a quality system in accordance with 21 CFR Part 820? 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. FDA recommends that laboratories seeking to develop and use their own VTM refer to CDC's SOP: Preparation of Viral Transport Media. The full name of UTM is universal transport media, which is literally translated as universal transport media. 4. Directly process samples using extraction kits and workflows. 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. 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. It would have a long shelf life (either in a frozen or non-frozen state). M&1,h,LUTM~ }GI ]=O%|F? 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. [56 0 R 57 0 R 58 0 R 59 0 R 60 0 R 61 0 R 62 0 R 63 0 R 64 0 R 65 0 R 66 0 R 67 0 R] ARUP's test is based on the CDC assay but has been optimized for state-of-the-art instrumentation and an automated specimen extraction process.
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