Microfiber provides high surface area for rapid capillary absorption of fluid specimens. Flocking (brush-like nylon fibers) is ideal for sample collection from irregular surfaces. Leave swab in place for several seconds to absorb secretions. Thank you for your interest in supporting Kaiser Health News (KHN), the nation's leading nonprofit newsroom focused on health and health policy. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. If the applicator handle requires additional trimming, it is also important to perform the trimming with a sterile pair of scissors to prevent contamination of the sample. For additional information, see the FDA's Letter to Health Care Providers, issued October 7, 2020, on providing clear instructions to patients who, in a health care setting, self-collect an anterior nares nasal sample for SARS-CoV-2 testing. Properly remove gloves and discard in appropriate receptacles. Stop when you feel resistance at turbinates (see fig 8). When traditional swabs (such as spun fiber, foam, or flocked) are not available, 3D printed swabs may also be considered (see additional FAQ below on this page). To mitigate the supply issues, recommendations are two-fold: 1.Reduce demand for swab usage by: using a single swab for sampling throat then nose reduce level of testing for non-COVID. The test used at these community testing events is a PCR test done by an anterior nares swab to determine the presence of SARS-CoV-2, the virus that causes COVID-19. Chemtronics offers the Coventry Sterile Flocked Swab (part #66010ST, see fig 9) that has been engineered to efficiently collect biological fluids for elution and analysis. Chemtronics offers a line of Coventry Sterile Sampling Swabs [https://www.chemtronics.com/coventry-flocked-sampling-swab] that are FDA approved and manufactured and sterilized to the highest standard. Each pellet contains A549 lung epithelial cells. FDA is aware that some users have reported concerns of brittle 3D printed swabs that have broken into multiple sharp pieces, and non-traditional capture geometries that may not capture the sample sufficiently. The HSC should yield a positive result with the RP primer and probe set and negative results with all 2019-nCoV markers. Microfiber provides high surface areas for rapid capillary absorption of fluid specimens. This product is intended for use with Xpert Xpress SARS-CoV-2 assay on the GeneXpert Systems (Cepheid). All specimen collection should be conducted with a sterile swab. This is also available in its non-encapsulated form upon request. The isolate is USA-WA1/2020, chemically inactivated. Due to the increased technical skill and equipment needs, collection of specimens other than sputum from the lower respiratory tract may be limited to patients presenting with more severe disease, including people admitted to the hospital and/or fatal cases. The following are the three most common methods of swab sterilization: Coventry Sampling Swabs come in individual sterile packaging. The head material structure is linear and open, which facilitates rapid absorption and thorough release of specimens into analyzing solutions. This RNA extraction procedural control is used to demonstrate successful recovery of RNA as well as extraction reagent integrity. Additional information on packing, shipping, and transporting specimens can be found atInterim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). Healthcare providers should wear a form of source control(face mask) at all times while in the healthcare facility. NP swab is the reference sampling method for SARS CoV2 diagnosis, as recommended by the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) (Center for Diseases Control Prevention, 2020; WHO, 2020a,b).The CDC only endorses the use of synthetic fiber-tipped swabs like rayon or nylon swabs on their recent guidelines for SARS-CoV-2 diagnosis . Instructions for collecting a capillary blood specimen by fingerstick: For an additional visual guide, see the Steps for Collecting Finger Stick Capillary Blood Using a Microtainer. Coventry Sterile Sampling Swabs are sterilized using the ethylene oxide (EtO or EO) process, which ensures the swabs are free from human DNA, enzymes that degrade DNA and RNA, and polymerase chain reaction inhibitors. Allocations were predetermined to maximize state and territory testing using a data-driven algorithm based on population, high incidence areas, and COVID-19 Task Forces directives. The COVID-19 pandemic has brought constant change to our lives, including how we test for the virus. We note that the information below provided about testing supplies is not intended to alter any already issued EUA for a COVID-19 diagnostic test nor is it intended to speak to any specific FDA regulatory requirement. This product contains recombinant Alphavirus encapsulating a synthetic, full SARS-CoV-2 RNA genome, which is non-infectious and replication-deficient. The single-use combination test kit uses a self-collected nasal swab and produces results in 30 minutes with an accuracy rate over 90% for influenza A and B and Covid, according to the FDA. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Health care workers collected a swab sample from the patients' oropharynx or nasopharynx according to testing guidelines for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 . Swab shortages have led to a bottleneck in Covid-19 testing, but the FDA announced Thursday a broader range of swabs can now be used. WARNING: Media containing guanidine thiocyanate or similar chemicals, including Longhorn PrimeStore MTM, Zymo DNA/RNA Shield, as well as that found in the Spectrum Solutions Saliva Collection Device, should not be used with in vitro diagnostic platforms that use bleach (sodium hypochlorite) in the testing platform or during laboratory processes. To make sure a test is working properly, kits also include DNA unrelated to SARS-CoV-2. A: Below is information regarding positive control material. CDC twenty four seven. A: Absorbent tipped applicators (i.e., swabs), whether produced through traditional manufacturing or other means such as additive manufacturing (i.e., 3D printing), are generally Class I medical devices regulated under 21 CFR 880.6025. When the bleach interacts with the guanidine thiocyanate in the transport media, it produces dangerous cyanide gas. Not all medical swabs are the same. A: The FDA issued the Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergencyto help address transport media availability concerns resulting from the COVID-19 public health emergency. Performing the test incorrectly may result in a false negative, which could put other people at risk. Be the first to receive email alerts on special offers, new products, and more delivered right to your in-box. Gently and slowly insert a minitip swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Microfiber provides high surface area for rapid capillary absorption of fluid specimens. Labs should be aware that inaccurate or invalid results may occur when using media containing guanidine thiocyanate or similar chemicals with tests which are not designed for use with such chemicals. Additionally, rayon swabs may not be compatible with all molecular testing platforms. The back of each package contains brief instructions (Fig 14). Insert the entire collection tip of the swab provided (usually to of an inch, or 1 to 1.5 cm) inside the nostril. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Manufacturers are responsible for ensuring their products' performance is appropriate for its intended use. Introduction. This is the golden age of swabs, meaning we will pay gilded prices for a coronavirus antigen test, the new nose candy, to jab a swab up our nostrils in the comfort of home though comfort. The head material of Coventry 66010ST Sterile Flocked Swab is a nylon microfiber with a polystyrene (or ABS) handle. However, the induction of sputum is not recommended due to the possibility of aerosol production during the procedure. Obtaining a good sample is necessary for getting accurate test results. Carefully insert the swab head into the posterior pharynx and tonsillar areas (Fig 6). Press the fingerstick collection device or lancet firmly against side of the finger pad and activate to perform the puncture. RT-PCR converts viral RNA to DNA and amplifies the genetic sequence, making. For diagnostic testing for current SARS-CoV-2 infections, CDC recommends collecting and testing an upper respiratory specimen. The nose swab PCR test for COVID-19 is an accurate and reliable test for diagnosing COVID-19. The head material of Coventry 66120ST Sterile Foam Swab is polyurethane foam with a polystyrene (or ABS) handle. If both NP and OP specimens are collected, combine them in a single tube to maximize test sensitivity and limit use of testing resources. A SARS-CoV-2 full-length, synthetic genome (Wuhan-Hu-1 strain; GenBank number MN908947.3), cloned in a bacterial artificial chromosome. Rather, as stated above, the information is being provided to help address availability concerns regarding certain critical components of COVID-19 diagnostic tests during this pandemic. Blood specimens are used for antibody (or serological) tests and, for some tests authorized by the US Food and Drug Administration that are used at the point-of-care, specimens are collected by pricking the skin with a fingerstick device. The patient can then self-swab and place the swab in transport media or sterile transport device and seal. Some diagnostic tests use other samples such as mid-turbinate, nasopharyngeal,. When swabbing the nose for rapid at-home COVID-19 tests, the sample must be collected from cells on your nasal walls. Some of the specimen types listed below will not be appropriate for all tests. All rights reserved. Product # NATSARS(COV2)-ST: NATtrol SARS-Related Coronavirus 2 (SARS-CoV-2) Stock (1mL). Medical Grade Plastic ABS handle; Total Length: 150 mm, Flocked Tip: 20 mm, Break point: 80 mm; . The COVID-19 test in schools uses a shallow nasal swab. Catheter should reach depth equal to distance from nostrils to outer opening of ear. If you cannot identify the type of transport media in the specimen collection tubes or if you do not know if the transport media contains guanidine thiocyanate or similar chemicals as an ingredient, handle tubes as if they contain guanidine thiocyanate or similar chemicals. Over the past weekend, Washington State's Department of Health received a shipment of thousands of coronavirus test nasal swabs that were incorrectly labeled as cotton Q-tips. SCITUS know, understand Lead Test Kit with 30 Testing Swabs Rapid Test Results in 30 Seconds Just Dip in White Vinegar to Use Lead Testing Kits for Home Use, Suitable for All Painted Surfaces. Sterile swabs for upper respiratory specimen collection may be packaged in one of two ways: When individually wrapped swabs are not available, bulk-packaged swabs may be used for specimen collection; however, care must be exercised to avoid SARS-CoV-2 contamination of any of the swabs in the bulk-packaged container. To avoid contamination, follow these handling guidelines: Insert the swab into the transport medium and break the handle at the breakpoint after sampling. A flocked nylon swab stick is used to take the samples and it is rotated at the site for proper . A: Based on the available evidence at this time, the FDA believes that the following specimen types are appropriate for swab-based SARS-CoV-2 testing: Although all of the above options are appropriate for clinical testing, nasopharyngeal specimens are generally considered to yield the most sensitive test results and are therefore the preferred choice as a reference (comparator) for clinical investigations and validating new methodology. Audere has granted a general Right of Reference to any organization who wishes to access and use Audere's "Lower nasal swab collection" instructions for lower nasal swabs administered at a testing site. This is important both to ensure patient safety and preserve specimen integrity. Bronchoalveolar lavage, tracheal aspirate, pleural fluid, lung biopsy (generally performed by a physician in the hospital setting), Sputum (collected under the guidance of a trained healthcare professional). Follow the instructions as explicitly described within the tests Emergency Use Authorization (EUA) Instructions for Use. Place swab, tip first, into the transport tube provided. 40 / Piece. Under certain clinical circumstances (e.g., for those receiving invasive mechanical ventilation), a lower respiratory tract aspirate or bronchoalveolar lavage specimen can be collected and tested as a lower respiratory tract specimen. Inactivating transport media (ITM), which are not included in the scope of the guidance, are intended to inactivate virus and stabilize nucleic acids in the sample. Anterior nares sampling collects a nasal secretion sample from just inside the nose. Be sure to ask if there is a cost for testing and how long it will take to receive the test results. Many molecular influenza (flu) virus and respiratory syncytial virus (RSV) tests require the same components as many SARS-CoV-2 molecular assays. Flocked nylon fibers provide greater surface area to collect and absorb secretions, and it is also more comfortable than many alternatives. FDA has published a guidance on technical considerations for additive manufactured medical devices, Technical Considerations for Additive Manufactured Medical Devices, and has a webpage on 3D printed devices, accessories, components, and parts relating to the COVID-19 Public Health Emergency Response. For more information, go to CDC guidelines at https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html. Per CDC recommendations, the swab head should be made of a flocked material with a flexible wire or plastic shaft. Simply twirling the swab or leaving it in the nares region may not produce an adequate sample for testing, and therefore may decrease the sensitivity of the test. This page is part of the FAQs on Testing for SARS-CoV-2 and provides answers to frequently asked questions related to COVID-19 testing supplies. The .gov means its official.Federal government websites often end in .gov or .mil. It may be possible to leverage some data provided by the swab designer or other facilities; however, appropriate controls must be in place, and data validation should demonstrate applicability of such data. Home specimen collection methods may also be used as part of an IRB approved study. Sterile swabs should be used for the collection of upper respiratory specimens. Anyone performing fingerstick procedures should review the following recommendations to ensure that they are not placing persons in their care at risk for infection. The following specimen collection guidelines follow standard recommended procedures. . The Chinese coastal city of Xiamen is testing freshly caught fish, crabs and even shrimp for Covid-19 as it goes all out to contain a spiraling outbreak -- a policy drawing ridicule online and . Product # 10006626: Hs_RPP30 Positive Control. 1 offer from $17.29. People waited in long lines for drive-through COVID-19 tests administered by OHSU at the Oregon Convention Center on Thurs., Nov. 12, 2020. Rub the swab head over tonsillar pillars and posterior oropharynx, while avoiding contact with the tongue, gums, and teeth. Media containing guanidine thiocyanate or similar chemicals produce a potentially hazardous chemical reaction that releases cyanide gas when exposed to bleach. This test looks for SARS-CoV-2 genetic material. For each test, you'll have a sterile swab, test cassette, prefilled extraction tube, and dropper tip. This control plasmid contains in vitro transcribed RNA containing the N, S, E and Orf1ab regions. A: For anterior nares specimen collection, the entire tip of the swab should be placed inside the nose, and the side of the swab tip should be rubbed with moderate pressure against as much of the wall of nares region as possible, moving the tip through a large circular path inside the nose. The COVID-19 self-swab kit used by Stanford Medicine researchers in the Community Alliance to Test Coronavirus at Home (CATCH) Study was granted emergency-use authorization by the Food and Drug Administration on Nov. 24. This study suggests that polyurethane foam swabs perform better than nylon flocked swabs for the collection of secretions from anterior nares in the Quidel QuickVue Influenza A+B test. For an additional visual guide, see the Nasopharyngeal/Nasal Aspirate or Nasopharyngeal/Nasal Wash sections in the Influenza Specimen Collection infographic. Elena began the proceedings by unwrapping the sterile swab from a BinaxNOW rapid test for SARS-CoV-2, part of the family's dwindling supply. Insert the swab through the nostril, and keep it parallel to the palate, not upwards (Fig 2). Yasharyn Mediaid Solutions Ludhiana This guidance was issued to help address transport media availability concerns resulting from the COVID-19 public health emergency. For the various testing methods detailed above, the CDC guidelines recommend the head material be made of synthetic material, and specifies flocked surfaces for all but oropharyngeal sampling. Note: This is an aerosol-generating procedure and likely to generate higher concentrations of infectious respiratory aerosols. (4/22/20), Product # NR-52286: SARS-Related Coronavirus 2, Isolate USA-WA1/2020, Heat inactivated, Product # NR-52287: SARS-Related Coronavirus 2, Isolate USA-WA1/2020, Gamma-Irradiated, Product # VR-1986HK: Heat-inactivated SARS-CoV-2 (strain 2019-nCoV/USA-WA1/2020), Product # NATSARS(COV2)-ERC: NATtrol SARS-Related Coronavirus 2 (SARS-CoV-2) External Run Control (6 X 0.5mL). Upon request, Twist Bioscience can manufacture synthetic SARS-CoV-2 RNA controls for any new strains as they evolve. Follow the manufacturers instructions if using their collection device. #1. Titan Biotech VTM Covid-19 Sample Collection Kit 1 Tube Of Viral Transport Media With 1 Swab. The head material structure is linear and open, which facilitates rapid absorption and thorough release of specimen into analyzing solution (Fig 12). The Pediatric Infectious Disease Journal 2020: volume, 39 . (11/15/21), Q: If I do not have human extraction control material, how can I obtain it? The process for sterilizing COVID-19 swabs is highly regulated and completely safe. (11/15/21). ET Place specimen in a sterile viral transport media tube. Close the bulk swab container after each swab removal and leave it closed when not in use to avoid accidental contamination. A nasal swab for a COVID-19 test can be difficult for anyone, especially kids. Peel apart the handle-side of the package. At least four of these sweeping circular motions should be performed in each nostril. These products contain recombinant Alphavirus encapsulating synthetic SARS-CoV-2 RNA targets (#0505-0126 contains ORF1a/RdRp/E/N; #0505-0159 is full genome that is non-infectious and replication-deficient). The demand for testing has increased as the rate of . The Clinitest Rapid Covid-19 comes with five tests per pack. Spot Cleaning Flux Residues Using BrushClean System. Rub swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue, teeth, and gums. In FDA-approved at-home nose swab COVID-19 tests, the pH of the buffer is designed specifically for nasal swab specimens, according to Dr. Rock. There are two main types of viral tests: nucleic acid amplification tests (NAATs) and antigen tests. Collect 1-5 mL of saliva in a sterile, leak-proof screw cap container. A SARS-CoV-2 full-length, synthetic genome (Wuhan-Hu-1 strain; GenBank number MN908947.3) cloned in a bacterial artificial chromosome and that includes a T7 promoter with a poly(A) tail to simplify reverse genetics workflows for viral genome activation. Chemtronics Technical Support is available from: Monday through Friday 8 AM to 5 PM EST. Most COVID-19 testing swabs used in the U.S. are made mainly by two companies: Puritan Medical Products in Maine and a company in Italy, a coronavirus outbreak epicenter. CDC guidelines recommend that sterile swabs be used for the collection of upper respiratory samples. Once the sample has been taken, the swab is either placed: in a preserving liquid and sent to a laboratory for testing or Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and may inhibit molecular tests. The supply of testing equipment is vital in controlling the spread of SARS-CoV-2. A health care professional collects a fluid sample by inserting a long nasal swab (nasopharyngeal swab) into your nostril and taking fluid from the back of your nose. The system is available in 3 flocked swab formats: regular (white), minitip . Please note that this policy does not apply to multi-analyte diagnostic tests that have been issued an EUA and are intended to diagnose and differentiate SARS-CoV-2 infection from other viruses, including influenza viruses and RSV. This is a non-encapsulated product consisting of 6 non-overlapping 5 kb synthetic RNA fragments spanning near the entire viral genome (>99.9%, reference NC_045512). Vircell (Vircell US distributor is BioDominium Diagnostics): Order by emailing, Product # MBTC030-R: Amplirun TOTAL SARS-CoV-2 CONTROL (SWAB). While there have been swab shortages to fill the urgent need of COVID-19 testing, care still needs to be taken to qualify and source the best swab for the type of sampling that is required. In certain circumstances, one test type may be recommended over the other. Additional information about the policies in this guidance can be found on FDA's FAQs on Viral Transport Media During COVID-19 webpage. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Make sure you stop when you feel resistance or the distance from the ear to the nostril is the same, which indicates the swab head is in contact with the nasopharynx. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. The most common tests for COVID-19 are PCR tests, involving a nose and throat sample taken with a cotton swab. . The FDA believes that sample collection with a flocked swab, when available, is preferred. It is important that the person performing the specimen collection, whether an HCP or self-swabbing individual in a health care or home setting, have a clear and appropriate set of written or electronic instructions to help them perform the task correctly, for example, from the CDC or the lower nasal swab collection instructions developed by Audere, a Washington State nonprofit corporation. Insert swab into the posterior pharynx and tonsillar areas. These cookies may also be used for advertising purposes by these third parties. | Privacy Statement | Accessibility. Proper specimen collection is the most important step in the laboratory diagnosis of infectious diseases. The procedure is often unpleasant, and the tests results require laboratory analysis. (11/15/21), Q: What are the regulatory requirements for 3D printed swabs, whether fabricated by a commercial manufacturer or at a hospital, laboratory, or other facility? The second polyester swab was then inserted in a dry tube (10 mL BD Vacutainer), stored at 4C, and sent to a reference laboratory for immediate testing. Healthcare providers should maintain proper infection control, including standard precautions,and wear an N95 or equivalent or higher-level respirator, eye protection, gloves, and a gown, when collecting specimens. Maine Molecular Quality Controls: Order by emailing, Product # M441: BioFire RP2.1/RP2.1plus Control Panel M441. Insert the swab head into a sterile transport media tube, snap off the swab handle at the break-point, seal the cap, and label the sample (Fig 4). Flock (Nylon) Mini-tip swab: 81.5mm: 152mm: 3mm: . Use Flocked Swabs to recover up to twice as many infected cells as with mattress swabs. Product # HE0058N: Helix Elite Inactivated Standard (Negative Cellularity Control). To receive email updates about COVID-19, enter your email address: We take your privacy seriously. Manufacturers may also wish to consider resources available through the NIH's 3D Print Exchange. From the product sheet: "Note that the positive reference material may contain traces of RNase P and therefore generate a positive RNase P result; it is not designed or intended to be used as an RNase P reference material. Human RNA can be extracted from human specimens or cultured human cells and used directly as the RP positive control. Flocked nylon has fibers which provide greater surface area to collect and absorb secretion, and it is also more comfortable than many alternatives. The information about swabs provided above is based on limited available evidence, and further research is needed in this area. Product SKU 102024: Twist Synthetic SARS-CoV-2 RNA Control 2 (MN908947.3), Codex DNA: Order by emailing covid19@codexdna.com OR following the instructions on their, Product # SC2-RNAC-0100: Synthetic SARS-CoV-2 RNA Controls, non-overlapping. Change gloves that have touched potentially blood-contaminated objects or fingerstick wounds before touching clean surfaces. At this time, there are no dedicated neonatal nasopharyngeal (NP) swabs available in Ontario. Specimen Collection for . Note: Follow manufacturers instructions when using another collection device. Nasopharyngeal and oropharyngeal specimens are not appropriate for self-collection. This video demonstrates the collection of specimens from the surface of the respiratory mucosa with nasopharyngeal swabs for the diagnosis of Covid-19 in adults and in children. . Other information that must be provided to the laboratory when requesting a test includes the sex and age or date of birth of the patient; the test(s) to be performed; the specimen source; the date and, if appropriate, the time of specimen collection. Current advice is to collect an NP swab when testing neonates for COVID-19. Once the bagged samples are ready to be processed, laboratory staff removes them from the biohazard containers and commences the intake processa visual inspection to ensure every sample includes a nasal swab and is properly identified and sealed. Cookies used to make website functionality more relevant to you. This product is a DNA plasmid containing a portion of the RPP30 gene. Product # M430: Xpert SARS-CoV-2 Control Panel M430. Adding saliva to the mix could contaminate your . Healthcare providers can minimize PPE use if patients collect their own specimens while maintaining at least 6 feet of separation. Personnel must be trained to pack and ship according to the regulations and in a manner that corresponds to their function-specific responsibilities. Apply firm pressure to the puncture site with clean gauze for five to ten seconds after collecting the specimen to ensure bleeding has stopped. This is important to preserve both patient safety and specimen integrity. ", Products # 0505-0126 OR # 0505-0159: AccuPlex SARS-CoV-2 Reference Material Kits. Calcium alginate swabs are unacceptable and swabs with cotton tips and wooden shafts are not recommended. Chemtronics offers a line of Coventry Sterile Sampling Swabs [https://www.chemtronics.com/coventry-flocked-sampling-swab] that are FDA approved, manufactured and sterilized to the highest standard that can be used for COVID-19, flu and other testing. Simply twirling the swab against one part of the inside of the nose or leaving it in the nares region may not produce an adequate sample for testing, and therefore may decrease the sensitivity of the test. Thank you for taking the time to confirm your preferences. To find out more or withdraw your consent to all or some of the cookies, please refer to the, Coventry 12820 Precision Cleaning Solvent, Static Free Mat and Benchtop Reconditioner, CircuitWorks Conformal Coating Remover Pen, CircuitWorks Epoxy Overcoat (Adhesive Syringe), Chemask HV - High Viscosity Peelable Solder Mask, Chemask WF Water Filterable Solder Mask, FOCCUS Transportable I & M Fiber Optic Cleaning Kit, https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html. This is a non-encapsulated product consisting of 6 overlapping 5 kb synthetic RNA fragments spanning all of the entire viral genome (reference NC_045512). The US Department of Health and Human Services (HHS) is directly distributing nasopharyngeal (NP) swabs, based on state and territory testing plans that were submitted in response to the Coronavirus Aid, Relief, and Economic Security (CARES) Act requirements. Breath (performed by a qualified, trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests). For swab requests, delivery site changes, or other related requests contact COVID19.TestSupplies@hhs.gov. For more information on Registration and Listing, please contact the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov or see the How to Register and List page. Many laboratories may use bleach in their cleaning or decontamination processes in response to laboratory spills. This product is intended for use with BioFire RP2.1 and BioFire RP2.1plus assays. Facilities should ensure that all personnel who transport specimens via pneumatic tubes are trained in safe handling practices, specimen management, and spill decontamination procedures.