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 site is secure. calcium alginate swabs or swabs with wooden shafts, Q: Is there an example of anterior nares swabbing instructions that I could provide to my patients? 3M LeadCheck Swabs, Instant Lead Test, 8-Pack. For patients with productive cough, a sputum sample is an acceptable lower respiratory specimen. Flocking (brush-like nylon fibers) is ideal for sample collection from irregular surfaces. standard operating procedure for the preparation of VTM, International Air Transport Association (IATA) Dangerous Goods Regulations, U.S. Department of Transportations (DOT) Transporting Infectious Substances Safely, Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19), Biological Risk Assessment: General Considerations for Laboratories, Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition, Steps for Collecting Finger Stick Capillary Blood Using a Microtainer, Biosafety in Microbiological and Biomedical Laboratories (BMBL) (6th edition), Guidance for SARS-CoV-2 Point-of-Care Testing, Guidance Proposed Use of Point-of-Care (POC) Testing Platforms for SARS-CoV-2 (COVID-19), Information for Clinicians on Influenza Virus Testing, Information on Collection of Respiratory Specimens for Influenza Virus Testing, WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy, National Center for Immunization and Respiratory Diseases (NCIRD), FAQ: Multiplex Assay for Flu and SARS-CoV-2 and Supplies, Hospitalization Surveillance Network COVID-NET, Laboratory-Confirmed Hospitalizations by Age, Demographics Characteristics & Medical Conditions, Seroprevalence Surveys in Special Populations, Large-Scale Geographic Seroprevalence Surveys, Investigating the Impact of COVID-19 During Pregnancy, Hospitalization and Death by Race/Ethnicity, U.S. Department of Health & Human Services. Chemtronics offers theCoventry Sterile Foam Swab (part #66120ST, see fig 5) that has been engineered to efficiently collect biological fluids for elution and analysis. A negative test means you probably did not have COVID-19 at the time of the test. The head material of Coventry 66010ST Sterile Flocked Swab is a nylon microfiber with a polystyrene (or ABS) handle. The most common tests for COVID-19 are PCR tests, involving a nose and throat sample taken with a cotton swab. Then rotate the swab several times against nasal wall (Fig 8). Repeat in the other nostril using the same swab. Yasharyn Mediaid Solutions Ludhiana Product # HE0060S: Helix Elite SARS-CoV-2 Synthetic RNA (N-gene targets), Product # 9006 or 9009: SARS-CoV-2 Synthetic RNA (N-gene targets), Product # 9019VP: SARS-CoV-2 Synthetic RNA (E/RdRp gene targets), Product # 9029VP: SARS-CoV-2 Synthetic RNA (S-gene targets), Product # VR-3276SD: Quantitative Synthetic SARS-CoV-2: ORF, E, N, Product # VR-3277SD: Quantitative Synthetic SARS-CoV-2 RNA: Spike 5', Product # VR-3278SD: Quantitative Synthetic SARS-CoV-2 RNA: Spike 3', Product # COV019: Exact Diagnostics SARS-CoV-2 Standard. The Pediatric Infectious Disease Journal 2020: volume, 39 . Works well, requires clipping instead of using the break point on our particular specimen containers, but that is my . Chemtronics Technical Support is available from: Monday through Friday 8 AM to 5 PM EST. Laboratories should confirm the specimen has been obtained correctly and from the individual that is being tested. Consult CDC and other similar sources for specific guidelines. 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. The nasopharyngeal swabs required for the coronavirus tests are quite different from your standard Q-tips and the exploding need for them has created a bottleneck in the soaring demand for. For patients who develop a productive cough, sputum can be collected and tested when available for SARS-CoV-2. Facilities should ensure that all personnel who transport specimens via pneumatic tubes are trained in safe handling practices, specimen management, and spill decontamination procedures. The swabs were resuspended in 1 mL 1xPBS and stored at 4 C until testing. Users of ITM should carefully read the warnings and precautions noted in the labeling and confirm that each ITM is compatible with the test kits and procedures used in the laboratory. Follow the instructions as explicitly described within the tests Emergency Use Authorization (EUA) Instructions for Use. Links provided are for information purposes only and are not a recommendation by FDA to use that product. This is also available in its non-encapsulated form upon request. Introduction. Next was the saliva collection, and some did sublingual under the tongue swabs. For healthcare providers who are handling specimens, but are not directly involved in collection (e.g. (11/15/21), General Device Labeling Requirements page, Technical Considerations for Additive Manufactured Medical Devices, 3D printed devices, accessories, components, and parts relating to the COVID-19 Public Health Emergency Response, Q: What alternative transport media can I use to transport patient specimens for COVID-19 diagnostic testing? Flocking (brush-like nylon fibers) is ideal for sample collection from irregular surfaces. This product contains targets within the E/N/S/ORF1ab/RdRp regions. Product # SC2-FLSG-1111: SARS-CoV-2 full-length genome with T7 promoter. 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. Chemtronics offers the Coventry 66010ST and 66120ST Sterile Flocked Swabs to efficiently collect biological fluids for elution and analysis. RT-PCR converts viral RNA to DNA and amplifies the genetic sequence, making. Contact the testing laboratory to confirm accepted specimen types and follow the manufacturer instructions for specimen collection. Press the fingerstick collection device or lancet firmly against side of the finger pad and activate to perform the puncture. Open mouth and create an open pathway by depressing the tongue. (11/15/21), Q: If I do not have human extraction control material, how can I obtain it? 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. 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. If you live in the Houston area, you can find local testing information by calling 832-393-4220. All specimen collection should be conducted with a sterile swab. If a deviated septum or blockage create difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril. For purposes of entry into the United States, vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. Upon request, Codex DNA can manufacture desired synthetic DNA and RNA constructs to support customers' COVID-19 related needs. The head material of Coventry 66010ST Sterile Flocked Swab is a nylon microfiber with a polystyrene (or ABS) handle. A special 6-inch cotton swab is inserted up each of your nostrils and moved around for about 15 seconds. Hold the hand of the person being tested in a downward position and massage the hand to improve blood flow into the fingers. 8125 Cobb Center Drive Kennesaw, GA 30152, Copyright 2023 Chemtronics. There are three main kinds of Covid nasal swab tests: nasopharyngeal (the deepest), mid-turbinate (the middle) and anterior nares (the shallow part of your nose). To avoid contamination, follow these handling guidelines: Insert the swab into the transport medium and break the handle at the breakpoint after sampling. Individually wrapped (preferred when possible). Saline is also an acceptable transport medium for some COVID-19 viral assays, including the Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay. Aerosol-generating procedures potentially put healthcare providers and others at an increased risk for pathogen exposure and infection. 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. When patients are self-collecting swabs under clinical supervision: Hand a swab to the patient only while wearing a clean set of protective gloves. The Agency is aware that devices produced at different 3D printing facilities can have different characteristics that may affect safety and effectiveness even when using the same printers, resin, and design. Microfiber provides high surface area for rapid capillary absorption of fluid specimens. Product # 52030: Armored RNA Quant SARS-CoV-2. Properly remove gloves and discard in appropriate receptacles. All authorized tests can be found on the EUA page and authorizations for self-collection at home are noted in the test's Letter of Authorization. The COVID-19 pandemic of 2020, which is caused by the SARS-CoV-2 (commonly known as the novel coronavirus), has caused a huge spike in demand for sampling swabs. Jan. 11, 2022 -- Many Americans are familiar with the rapid antigen tests for COVID-19 that involve swabbing the nose. 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. Publication types Comparative Study Evaluation Study Research Support, Non-U.S. Gov't MeSH terms Adolescent Antigens, Viral / analysis* Bodily Secretions / virology* They help us to know which pages are the most and least popular and see how visitors move around the site. Never reuse lancets. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Wipe away the first drop of blood and follow manufacturer instructions to fill the capillary collection tube or apply the second drop of blood to the test device. 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 patients who develop a productive cough, sputum can be collected and tested for SARS-CoV-2 when available. 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. Change gloves that have touched potentially blood-contaminated objects or fingerstick wounds before touching clean surfaces. For examples of anterior nares swabbing instructions, refer to the CDC instructions or the lower nasal swab collection instructions developed by Audere, a Washington State nonprofit corporation. Use only synthetic fiber swabs with thin plastic or wire shafts that have been designed for sampling the nasopharyngeal mucosa. The head material of the Coventry 66010ST Sterile Flocked Swab is a nylon microfiber with a polystyrene (or ABS) handle. Handles are scored for easy breaking for insertion into the transport vial (Fig 13). Product # 10006625: 2019-nCoV_N_Positive Control. A: All transport media should be sterile to avoid contamination of the specimen. (see fig 3). Extracted viral genomic RNA: Viral genomic RNA may be acquired through extraction of SARS-CoV-2 positive patient samples or acquired through commercial sources. Check out other sources to put the claim into context While doing research for. Microfiber provides high surface area for rapid capillary absorption of fluid specimens. This guidance is intended for healthcare providers or health department staff who are collecting specimens from others in a healthcare setting or at the. Many molecular influenza (flu) virus and respiratory syncytial virus (RSV) tests require the same components as many SARS-CoV-2 molecular assays. 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. 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. Acceptable Swab Types for COVID Testing MI6695 Rev 4.00 Page 1 of 2 Nasopharyngeal and throat swabs are the preferred specimens for COVID-19 testing and have equivalent sensitivity. This product contains approximately 1,000,000 copies/mL. Lab personnel should also exercise caution if you cannot identify the type of transport media in the specimen collection tubes or if you do not know whether the transport media contains guanidine thiocyanate or similar chemicals as an ingredient, since warnings apply and special precautions should be taken for such ingredients (see the answer to the question regarding alternative types of transport media below). It contains segments from the RdRp, E, and N (including both N1/N2 targets) genes. Genome modifications and editing are available. While rotating the swab by rolling the handle in the fingertips, gently insert the swab less than one inch (about 2 cm) into the nostril. Testing for otherpathogens by the provider should be done as part of the initial evaluation, as indicated, but should not delay testing for SARS-CoV-2, the virus that causes COVID-19. Anterior nares sampling collects a nasal secretion sample from just inside the nose. Increased cell count Decrease rejected samples Home FLOQSwabs Features & Benefits Ordering Information Product Documentation However, the induction of sputum is not recommended due to the possibility of aerosol production during the procedure. DNA plasmid: Please note that if a DNA plasmid control is used, a method to evaluate performance of the reverse transcription step should be included. The information about swabs provided above is based on limited available evidence, and further research is needed in this area. Thank you for taking the time to confirm your preferences. 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. 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. 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: Follow manufacturers instructions when using another collection device. The head material of Coventry 66120ST Sterile Foam Swab is polyurethane foam with a polystyrene (or ABS) handle. But recent data and FDA approvals have shown that saliva can do an equally good job in an appropriate clinical setting. 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. Contact Supplier. Adding saliva to the mix could contaminate your . handling self-collected specimens) and not working within 6 feet of the patient, follow Standard Precautions.