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. Viral Transport Media. UNSPSC Code. . Please check availability. FAX: 0711-3704589, COMPANY PROFILE 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. application/pdf Safe molecular transport media (MTM) ready for monkeypox and COVID-19 samples. The results were equivalent or superior to the media in the comparison. 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. 46 0 obj Add 2mL of the Gentamicin/Amphotericin B mixture to the previously formed HBSS with FBS. Size: Tube dimension: 16 X 100mm Media: 3 ml Swabs 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. Single Use Samplers manufactured after 15 October, 2020, Universal Transport Medium (UTM), Cat. COVID-19 has led to a significant increase in global demand for PrimeStore MTM, which is the only FDA Class II cleared device for microbial nucleic acid storage and stabilization (RNA and DNA) available for the safe transportation of samples which may contain viruses. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. <> Some growth of contaminants might be observed during the long period of transport. Orthopoxvirus (includes monkeypox virus) by PCR is a real-time polymerase chain reaction (PCR) test to detect the DNA of orthopoxviruses, including monkeypox. Dispense 1.02.0 ml of transport medium into sterile plastic screw-cap vials. As multiple infectious disease tests can be processed from one sample swab, this makes PrimeStore MTM ideal for the approaching flu season. In fact, the inactivated or activated virus preservation solution does not say which is better. PrimeStore MTM (molecular transport media) is specifically designed to safely inactivate pathogenic samples whilst preserving and stabilizing the released DNA and RNA. This medium can serve as a cryoprotectant for clinical viruses, including Cytomegalovirus and Varicella-zoster virus. Nasopharyngeal and Oropharyngeal swabs (e.g. 50. Glass Sterile Saline Tube Inside U50. A single company produces most of the world's supply of viral transport media and is located in Europe, where some of the earliest and worst COVID-19 outbreaks occurred, affecting . MicroTest Tubes come with 1.5mL or 3mL of liquid medium in a 15mL conical tube with 3 glass beads. Viral Transport Medium (VTM) is ideal for transporting sample for the diagnosis of viral infections. 4. Parafilm or tape the connection and lid of the sterile trap before transport. A: As described in section IV.B of the FDA's COVID-19 Transport Media Policy, the FDA does not intend to object to the distribution and use of viral transport media (VTM) by commercial manufacturers, without a 510(k) or 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. Intended Use: The collection and transport of clinical specimens containing viruses, Chlamydiae, mycoplasma or ureaplasma from the . This is enabling them to bring back those who may be self-isolating due to concerns over infection, or that of a family member. 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. 330CHL. Microsoft Word for Microsoft 365 The COVID-19 Transport Media Policy explains that following completion of validation, notification that the commercial manufacturer intends to distribute the transport media should be. 2 0 obj 49 0 obj These optimizations will allow for . Liquid transport media are used primarily for transporting swabs or materials released into the medium from a collection swab. Offers flexibility in transport temperature rangesroom temperature or refrigerated. COPYRIGHT: HUBEI NEW DE SHENG MATERIAL SCIENCE AND TECHNOLOGY CO., LTD.. This page includes questions and answers regarding the policies outlined in the Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. 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. Take a tissue culture medium 199, containing 0.5% bovine serum albumin (BSA). Blood collection tube additive 48 0 obj 3 0 obj TCID50 and blind passage techniques were used to test for any infectious virus still recoverable from all samples treated with the inactivation reagents. 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. 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. ** 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. [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] 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. Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. 43 0 obj 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. A total of 23 commercial reagents designed for virus inactivation, clinical sample transportation and nucleic acid extraction were assessed for their ability to inactivate SARS-CoV-2. 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. Viral transport media are available from several commercial vendors who may use the terminology VTM (Viral Transport Medium) or UTM (Universal Transport Medium). 282 0 obj <>stream However, after inactivation SARS-CoV-2 material can be handled at a lower containment level, thereby opening up testing capacity in more laboratories. 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. MN Editors July 27, 2022 Culture Media Advertisements For information regarding the development and performance of tests for SARS-CoV-2, please see the FAQs on Testing for SARS-CoV-2 webpage. In the absence of a . The full name of UTM is universal transport media, which is literally translated as universal transport media. An ideal viral transport medium would possess many of the following characteristics; The following is the method of preparation for locally made VTMs for the nasal and throat swabs from humans: The following is a more elaborate procedure for the preparation of a larger volume of VTMs for humans: Video: Viral Transport Media by Sarah Bush Lincoln. Mix by inverting the bottle. 22-031-14 $306.00 / Pack of 50 Qty Check Availability Add to cart Includes: Only one swab is required, however, if two swabs are used to sample the same source, the specimen is acceptable. Specimen Lysis Tubes and Specimen Transport Medium (STM) are intended to be used for processing specimens for use with Hologic assays. Aliquot 3mL of the medium into individual sterile conical screw-capped tubes (such as 16x100mm tubes). However, modern molecular tests do not require viable virus, but just intact microbial nucleic acids. Add 10g veal infusion broth and 2g bovine albumin fraction V to sterile distilled water (to 400 ml). Liquid specimens such as CSF, bronchoalveolar lavage fluid, or urine should not be diluted in viral transport media. 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. Commercial manufacturers that wish to discuss an alternative formulation or validation approach should email CDRH-EUA-Templates@fda.hhs.gov. 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. It is mandatory to procure user consent prior to running these cookies on your website. Anterior nasal swab in saline. Cotton swabs/toothpicks/dry swabs will not work for reasons described above in the section on anaerobic cultures. No. Transport of viral specimens. In 2021, viral transport media accounted for a revenue share of 46% in the global viral transport medium market and dominated other segments. no. * Generally, transport media consisting of PBS/saline would be regulated by this regulation. The composition and preparation of different viral transport differ depending on whether the sample is taken from humans or other animals. Image Source: BD. endobj But opting out of some of these cookies may have an effect on your browsing experience. Viral agents vary widely in composition, stability, structure, morphology, and size. The difference between UTM, MTM and VTM virus transportmedia. Fluid samples such as tracheal wash specimens or peritoneal fluid should be submitted in sterile vials, preventing desiccation. To - 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. 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. The objective of this study was to determine the stability of severe acute respiratory syndrome CoV 2 (SARS-CoV-2) RNA in specimen transport media under various storage . IMM'VYeRpo6uA- For a complete list and further options please see our Cookie Policy. Hello, thank you for visiting my blog. 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. 303CHL. BD also offers a comprehensive range of transport media, including COVID-19 and SARS-CoV-2. Do I need to notify FDA that I am developing and distributing transport media under the policies outlined in the, Do I need to register my establishment with the FDA and list my device if I am developing and distributing transport media under the policies outlined in the, What commercial manufacturers are developing and distributing viral transport media (VTM) under the policy outlined in Section IV.B of the, What commercial manufacturers are developing and distributing PBS/saline transport media devices under the policy outlined in Section IV.C of the, CDC's SOP for the Preparation of Viral Transport Media, Centers for Disease Control and Prevention's (CDC's) Standard Operating Procedure (SOP): Preparation of Viral Transport Media, CDC's SOP: Preparation of Viral Transport Media, SOP: Preparation of Viral Transport Media, Culture Media, Non-Selective and Non-Differential, Microbial Nucleic Acid Storage and Stabilization Device, MedSchenker Smart Collection System (SCS), Disposable sampler Viral Transport Media manufactured after July 7, 2020, BioTeke Corporation Sterile Disposable Virus Sampling Swab Kits, GB Viral Transport Medium (VTM) Kit, Cat. 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. 53 0 obj 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. [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] Before sharing sensitive information, make sure you're on a federal government site. 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. The BD universal viral transport (UVT) system is designed to transport viruses, chlamydiae, mycoplasmas and ureaplasmas at room temperature. Universal transport media (UTM) or viral transport media (M4) Specimens should be transported on ice. Part of the reason why the three names appear is due to different usage habits in different regions and translation problems. Viral Transport Medium. <> Adenovirus, enterovirus, coxsackievirus A, cytomegalovirus (CMV), herpes simplex virus (HSV). %PDF-1.7 % She is particularly interested in studies regarding antibiotic resistance with a focus on drug discovery. Collect and preserve virus, chlamydia, mycoplasma and other specimens. While gently rotating the swab, insert Sonic VTM. 247d(a)(2)). The universal transport media segment accounted for 34 . 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 C_Restricted The lysis salt (guanidine hydrochloride, guanidine thiocyanate or others) in MTM can destroy the protective protein shell (capsid) of the virus, making the virus unable to infect again, but at the same time it retains the viral nucleic acid, which can be used for molecular diagnosis, sequencing and Nucleic acid amplification testing. Anupama Sapkota has a bachelors degree (B.Sc.) *Initial 4-log dilutions of PrimeStore MTM + viruses were required due to PrimeStore lysis of tissue culture. Directly process samples using extraction kits and workflows. 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. 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 <> R & D TEAM, Chemiluminescent reagent Both are pre-scored for easy breakage. The .gov means its official.Federal government websites often end in .gov or .mil. h0W7qmBX]q3$Ft-|O%rO^\&rI\`LMSm8yG\*T6Vph These cookies can be disabled in the browser settings. 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. Viral Transport Medium (VTM) is designed for hassle-free collection and transport of viral samples such as Covid-19, Swine flu etc. It is available in 1 mL or 3 mL vials in a flat-bottomed conical tube, regular polyester-tipped swabs, and a flexible minitip flocked swab (plastic or wire). 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. We often see three types in the sampling tube label: UTM, MTM, and VTM. In addition, on-label transport media options now . Because calcium alginate swabs are toxic for many enveloped viruses and may interfere with fluorescent antibody tests, they Clinical studies show that UTM paired with COPAN FLOQSwabs is equivalent to collections using aspirates and nasal washes for the diagnosis of respiratory virus infection. Recommendations to include foetal bovine serum as a source of protein to enhance the stabilising properties of viral transport media are contraindicated. 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. Note: Tube appearance may differ based on available supplies, but all will be labelled as Universal or Viral Transport Media, with an expiration date. These cookies will be stored in your browser only with your consent. Ledden, David (SHS POC ST) 5 Place specimen in sterile viral transport media tube. Use sterile swab to remove mucous or exudate and discard. *** Generally, transport media consisting of certain types of inactivating transport media (ITM) would be regulated by this regulation. endobj The transport medium comes in a plastic, screw cap tube and maintains organism viability for 48 hours at room or refrigerated temperature. 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). UTM, VTM, and Saline are on label. <> Biological buffer The full name of UTM is universal transport media, which is literally translated as universal transport media. 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. Adenovirus, astrovirus, CMV, norovirus, rotavirus, Fecal specimens (preferred) in a leak-proof container; fecal swabs in VTM, Adenovirus, CMV, HSV, papillomavirus, varicella-zoster virus(VZV). endobj 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. 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. Additionally, the BD CultureSwab MaxV (+) system is available in Amies gel medium without charcoal, in single- and double-swab formats, for the transport of aerobic and facultative anaerobic organisms5 Revision 7/07/20 TM 6 PrimeStore - MTM Beaver Inveox transport . uuid:90ed6ba5-1dd2-11b2-0a00-6a0000000000 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. h241U0P041S0R FlexTrans is noninhibitory to cell culture, making it usable not only for transport but for cell culture inoculation. Because they are labile to the environmental conditions, the viability of these viruses must be protected by using different solutions. Nasopharyngeal (NP) swabs also accepted in viral transport medium (discard OP swab included with viral transport medium), ESwab, or saline. Transport the specimen to the Microbiology . C7QX.R&OK2mb`]G/m=zytRYks~y&r3i?ho2L-I'H,lIn di.>a"r &apll,;b\bC%. Cepheid proactively developed Xpert Xpress CoV-2/Flu/RSV plus with several enhancements compared to Xpert Xpress SARS-CoV-2/Flu/RSV. MTM refers to the inactivated virus preservation solution, which is suitable for the collection, storage and transportation of infectious disease samples. The above post is embeded directly from the user's social media account and LatestLY Staff may not have modified or edited the content body. 2 . 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. A: No, the policies outlined in the COVID-19 Transport Media Policy only apply to certain transport media devices that can be used to transport certain clinical specimens that are tested by molecular or antigen diagnostic assays for use during availability concerns resulting from the COVID-19 public health emergency. ** 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. 838 0 obj Collect bronchoalveolar lavage and specimens from normally sterile sites in a sterile, leak-proof container (37777). Some manufacturers, VTM is more targeted than UTM, specifically for the preservation and transportation of virus samples. Testing can take place outside of containment, No. 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. VTM-M4RT. 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. Of the seven media, Richards viral transport, SPG, Virocult, and HH medium, followed closely by tryptose phosphate broth, best preserved HSV infectivity at both 4 degrees C and 22 degrees C. Analysis of decay rates of RSV revealed comparatively rapid decay in SPG and Virocult. We also use third-party cookies that help us analyze and understand how you use this website. This means that it is ready for safe testing immediately on arrival at a laboratory and without need for containment. Amies media, in single- or double-swab formats, for the transport of aerobes. According to the requirements of different manufacturers' products and testing environment. 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. Yes*. The remainder of the product codes listed above are within the policy's scope. Adenovirus was stable in all media and at both temperatures tested. Thus, viral transport media are prepared with the idea of providing appropriate conditions of temperature, pH, and nutrients. DO NOT refrigerate. Once a swab or biofluid is added to PrimeStore MTM the user has a snapshot in time for that inactivated microbial sample. 1 0 obj 54 0 obj PrimeStore MTM is also being used during the coronavirus pandemic by a number of businesses to provide COVID-19 testing services for their staff. Viral / Universal Transport Media and ESwabs; Sputum & Bronchoalveolar Lavage, Tracheal Aspirate; Viral / Universal Transport Media & ESwabs.
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