COVID-19 Testing Supplies: FAQs on Testing for SARS-CoV-2
This page provides answers to frequently asked questions related to COVID-19 testing supplies.
This section includes questions and answers regarding the policies outlined in the Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised). In this section, this guidance is referred to as the Policy for Coronavirus Disease-2019 Tests.
For a directory of FAQs related to SARS-CoV-2 testing, see FAQs on Testing for SARS-CoV-2.
A: On July 20, 2020, FDA issued the Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, to help address transport media availability concerns resulting from the COVID-19 public health emergency. Additional information about the policies in this guidance can be found on FDA's FAQs on Viral Transport Media During COVID-19 webpage.
On October 13, 2020, FDA issued the Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Many molecular influenza (flu) virus and respiratory syncytial virus (RSV) tests require the same components as many SARS-CoV-2 molecular assays. The policy outlined in this guidance aims to help expand access to certain FDA-cleared molecular tests intended for detection and identification of flu viruses, including molecular influenza tests that also detect and identify RSV, when manufacturers of previously cleared tests make certain modifications without FDA premarket review where the modification does not create an undue risk in light of the public health emergency. 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.
The FAQs in this section explain FDA's guidance policy on viral transport media (VTM) and, along with the Testing Supply Substitution Strategies slides, provide additional information about validated supply alternatives for labs to perform testing when there is a supply issue with some components of a molecular test. Download the slide show file (PPT - 1.5MB) and click Slide Show > From Beginning. (Release date: July 23, 2020)
The factual information in these slides and FAQs is being provided in the context of limited quantities of testing supplies during this public health crisis, based on the best available evidence at this time and in consultation with outside experts.
We note that the information below provided about testing supplies 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. 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.
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:
- Nasopharyngeal (NP) specimen collected by a healthcare professional (HCP) using a specialized mini-tip swab;
- Oropharyngeal (OP) specimen collected by an HCP using a swab with a full-sized tip;
- Mid-turbinate specimen collected by an HCP or by onsite self-collection using a specialized, flocked tapered swab; or
- Anterior nares specimen collected by an HCP or by onsite self-collection using a flocked swab, round foam swab, or spun fiber swab. For anterior nares specimen collection, a swab with a full-sized tip (OP-type swab) is generally preferred over a swab with a mini-tip (NP-type swab). See additional notes on the performance of anterior nares swabbing, below.
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. Nasopharyngeal and oropharyngeal specimens are not appropriate for self-collection. For patients with productive cough, a sputum sample is an acceptable lower respiratory specimen.
Other specimen types (for example, specimens collected using buccal and tongue swabs) may decrease the sensitivity of a test, so caution should be exercised when interpreting negative results. More data are necessary to better understand the performance when using specific saliva collection devices or other specimen types for COVID-19 testing.
It is important that the person performing the specimen collection, whether an HCP or self-swabbing individual in a health care 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. 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.
For anterior nares specimen collection, the entire tip of the swab (usually ½ to ¾ of an inch) 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 circle path inside the nose. At least four of these sweeping circular motions should be performed in each nostril. 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. For additional information, see the FDA's Letter to Health Care Providers, issued October 7, 2020, on providing clear instructions to patients who self-collect an anterior nares nasal sample in a health care setting for SARS-CoV-2 testing.
Multiple specimens from the same patient may be taken with a single swab. If a separate swab is used for collecting specimens from two different locations in the same patient, both swabs may be placed in the same vial in order to conserve collection and assay supplies.
The FDA believes that sample collection with a flocked swab, when available, is preferred. When traditional swabs (such as spun fiber, foam, or flocked) are not available, 3D printed swabs may also be considered (see additional FAQ). The FDA is aware that some users have reported concerns of brittle 3D printed swabs that have broken into multiple sharp pieces as well as non-traditional capture geometries that may not sufficiently capture the sample. These concerns should be considered in the evaluation of 3D printed swabs for use in COVID-19 testing.
All specimen collection should be conducted with a sterile swab. 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.
Please be aware that the CDC does not recommend use of calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit PCR testing. Additionally, rayon swabs may not be compatible with all molecular testing platforms. As noted above, analytical testing can be performed to confirm compatibility with individual platforms.
Due to concerns with specimen stability, transport, and appropriate collection materials, self-collection at home or at sites other than designated collection sites staffed by HCPs is currently only permitted with tests authorized explicitly for use in these settings in the EUA. Home specimen collection methods may also be used as part of an IRB approved study. 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 information about swabs provided above is based on limited available evidence, and further research is needed in this area.
To avoid specimens being wasted, if a lab is presented with a specimen that was collected or identified in a sub-optimal manner (for example, with a swab type for which there is less evidence of its effectiveness than the swab types listed in this FAQ), it may be appropriate for the lab to accept the specimen for analysis and note the circumstances on the report. These specimens may have decreased sensitivity, so caution should be exercised when interpreting negative results. 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).
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 circle path inside the nose. At least four of these sweeping circular motions should be performed in each nostril. 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.
It is important to have a clear and appropriate set of written or electronic instructions as a reference during sample collection to ensure an optimal sample is obtained.
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. 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.
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.
Please be aware that some transport media and SARS-CoV-2 testing platforms are not compatible. There is a risk of exposure to harmful cyanide gas, a by-product of a reaction between guanidine thiocyanate and similar chemicals used in certain transport media and bleach (sodium hypochlorite) used in certain SARS-CoV2 testing platforms or laboratory processes.
In general, Viral Transport Media (VTM) and Inactivating Transport Media (ITM) are the preferred transport media. Universal Transport Media (UTM) is a type of VTM. Additionally, all transport media should be sterile to avoid contamination of the specimen.
Please refer to FDA's guidance, Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency ("COVID-19 Viral Transport Media Policy") for FDA's policy regarding VTM during the COVID-19 public health emergency. As explained in this guidance, FDA does not intend to object to the distribution and use of commercial VTM under certain circumstances. This guidance was issued on July 20, 2020, to help address transport media availability concerns resulting from the COVID-19 public health emergency. Additional information about the policies in this guidance can be found on FDA's FAQs on Viral Transport Media During COVID-19 webpage.
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. There is not a single formulation that these types of media use, and they can consist of proprietary formulations intended to enhance inactivation and stabilization performance. 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. Many ITM contain guanidine thiocyanate or similar chemicals making them incompatible with certain in vitro diagnostic platforms, including those that use bleach (sodium hypochlorite), and with laboratory processes that use bleach. See warning below.
Please refer to the COVID-19 Viral Transport Media Policy for FDA's policies concerning alternative types of sterile transport media intended for use with molecular RT-PCR SARS-CoV-2 assays. These policies apply to swab-based specimen collection by healthcare providers (HCP), and to anterior nares (nasal) and mid-turbinate specimen collection onsite by self-collection. The best available evidence at this time indicates that the following transport scenarios will stabilize the SARS-CoV-2 RNA without meaningful degradation:
- Liquid Amies - Specimens can be stored in liquid Amies media for up to 72 hours at 4°C.
- Phosphate buffered saline and normal saline solution - Phosphate buffered saline (PBS), including molecular grade PBS when available, and other similar formulations including Dulbecco's PBS, can be used to collect and transport samples for molecular RT-PCR SARS-CoV-2 assays. If PBS is not available, normal saline may be used. FDA believes that a sterile glass or plastic vial containing between 1mL and 3mL of PBS or normal saline is appropriate. Specimens can be stored up to 72 hours at 4°C.
- "Dry swab transport" - swab specimens can be transported in a sterile tube without media for up to 72 hours at 4°C. Labs should use a validated rehydration procedure. Quantigen has provided a right of reference for any test developer to leverage their data demonstrating validity of their rehydration process, or developers may validate their own procedure.
There is limited data available on test performance with specimens which have been frozen in any transport media; therefore, specimen stability should be investigated if freezing is necessary.
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. Media containing guanidine thiocyanate or similar chemicals produce a potentially hazardous chemical reaction that releases cyanide gas when exposed to bleach. Many laboratories may use bleach in their cleaning or decontamination processes in response to laboratory spills. 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.
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. If you have questions about compatibility with guanidine thiocyanate media and your EUA test or test platform, please contact the manufacturer for further recommendations.
WARNING: Do not use Longhorn PrimeStore MTM, Zymo DNA/RNA Shield, or Spectrum Solutions Saliva Collection Device or other media containing guanidine thiocyanate or similar chemicals with the Hologic Panther or Panther Fusion Systems due to a disinfecting step involving bleach that is specific to the platform. When the bleach interacts with the guanidine thiocyanate in the transport media, it produces dangerous cyanide gas.
A: Following initial authorization of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC), several EUA amendments have been granted that include additional extraction options. All authorizations, including updates, are listed on FDA's EUA page.
Below is information regarding extraction platforms that the FDA understands have been validated for use with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. As noted in the footnotes below, some uses of certain extraction platforms are authorized under the CDC's EUA and others are not.
- Roche MagNA Pure LC*
Kit: Roche MagNA Pure Total Nucleic Acid Kit
Protocol: Total NA External_lysis- Add 100 μL of sample to 300 μL of pre-aliquoted TNA isolation kit lysis buffer (total input sample volume is 400 μL). Elution volume is 100 μL.
- Roche MagNA Pure Compact*
Kit: Roche MagNA Pure Nucleic Acid Isolation Kit I
Protocol: Total_NA_Plasma100_400- Add 100 μL of sample to 300 μL of pre-aliquoted TNA isolation kit lysis buffer (total input sample volume is 400 μL). Elution volume is 100 μL.
- Roche MagNA Pure 96*
Kit: Roche MagNA Pure 96 DNA and Viral NA Small Volume Kit
Protocol: Viral NA Plasma Ext LysExt Lys SV 4.0 Protocol or Viral NA Plasma Ext Lys SV Protocol- Add 100 μL of sample to 350 μL of pre-aliquoted External Lysis Buffer (supplied separately) (total input sample volume is 450 μL). Proceed with the extraction on the MagNA Pure 96. (Note: Internal Control = None). Elution volume is 100 μL.
- Roche MagNA Pure 24*
Kit: Roche MagNA Pure 24 Total NA Isolation Kit
Protocol: Pathogen 1000 2.0 Protocol- Add 100 µL of sample to 400 µL of pre-aliquoted External Lysis Buffer (supplied separately) (total input sample volume is 500 µL). Proceed with the extraction on the MagNA Pure 24. (Internal Control = None). Elution volume is 100 µL.
- QIAGEN QIAcube*
Kit: QIAGEN QIAamp® DSP Viral RNA Mini Kit or QIAamp® Viral RNA Mini Kit- Utilize 140 μL of sample and elute with 100 μL of buffer.
- QIAGEN*
Kit: QIAGEN QIAamp® DSP Viral RNA Mini Kit or QIAamp® Viral RNA Mini Kit- Utilize 100 μL of sample and elute with 100 μL of buffer or utilize 140 μL of sample and elute with 140 μL of buffer.
- QIAGEN EZ1 Advanced XL*
Kit: QIAGEN EZ1 DSP Virus Kit and Buffer AVL (supplied separately) for offboard lysis
Card: EZ1 Advanced XL DSP Virus Card- Add 120 μL of sample to 280 μL of pre-aliquoted Buffer AVL (total input sample volume is 400 μL). Proceed with the extraction on the EZ1 Advanced XL. Elution volume is 120 μL.
- QIAGEN EZ1 Advanced XL*
Kit: QIAGEN EZ1 Virus Mini Kit v2.0 and Buffer AVL (supplied separately) for offboard lysis
Card: EZ1 Advanced XL Virus Card v2.0- Add 120 μL of sample to 280 μL of pre-aliquoted Buffer AVL (total input sample volume is 400 μL). Proceed with the extraction on the EZ1 Advanced XL. Elution volume is 120 μL.
- bioMérieux NucliSENS easyMAG Instrument*
Protocol: General protocol (not for blood) using "Off-board Lysis" reagent settings.- Add 100 μL of sample to 1000 μL of pre-aliquoted easyMAG lysis buffer (total input sample volume is 1100 μL). Incubate for 10 minutes at room temperature. Elution volume is 100 μL.
- bioMérieux EMAG Instrument*
Protocol: Custom protocol: CDC Flu V1 using "Off-board Lysis" reagent settings.- Add 100 μL of samples to 2000 μL of pre-aliquoted easyMAG lysis buffer (total input sample volume is 2100 μL). Incubate for 10 minutes at room temperature. Elution volume is 100 μL. The custom protocol, CDC Flu V1, is programmed on the bioMérieux EMAG instrument with the assistance of a bioMérieux service representative. Installation verification is documented at the time of installation. Laboratories are recommended to retain a record of the step-by-step verification of the bioMérieux custom protocol installation procedure.
- KingFisher Flex Nucleic Acid Extraction System˜
Kit: Omega Bio-Tek Mag-Bind Viral DNA/RNA 96 Kit
Protocol: Please contact product_support@omegabiotek.com for instructions to upload the script and protocols for viral RNA extraction.- Add 200 μL of patient sample and elute with 60 μL. Use 5 μL of eluant in a 20 μL final amplification reaction volume.
- Applied Biosystems MagMAX™ Express-96 Magnetic Particle Processor˜
Kit: Applied Biosystems MagMAX™ Viral/Pathogen Ultra Nucleic Acid Isolation Kit
Protocol: MVP_Ultra_MMe96- Add 400 μL of sample and 50 μL of enzyme in a 96-well plate. Proceed with the extraction on the MagMAX Express-96 instrument. Elute with 100 μL TE buffer.
- Promega Maxwell RSC 48 Instrument^
Kit: Maxwell RSC Viral Total Nucleic Acid Purification Kit
Protocol: AS1330- Add 200 μL of sample and 30 μL of enzyme in a 96-well plate. Proceed with the extraction on the Maxwell RSC 48 instrument. Elute with 50 μL TE buffer.
- Promega Maxwell RSC 48 Instrument*
Kit: Promega Maxwell Viral Total Nucleic Acid Purification Kit
Protocol: Total Nucleic Acid- Add 120 μL of sample to 330 µL of pre-aliquoted External Lysis Buffer (300 µL Lysis Buffer plus 30 µL Proteinase K; supplied within the kit) (total input volume is 450 µL). Proceed with the extraction on the Maxwell® RSC 48. Elution volume is 75 µL.
- Beckman RNAdvance Viral XP˜
Kit: RNAdvance Viral XP extraction kit- Add 200 μL of sample and 150 μL of lysis buffer (LBF). After mixing, add 350 μL of binding buffer (VBE) (total input sample volume is 700 μL). Proceed with RNAdvanced magnetic capture protocol with 70% ethanol washes. Elution volume is 40 μL in nuclease-free water.
- PHASIFY˜
Kit: PHASIFY Viral RNA Extraction Kit- Sample input volume is 300 µL and the final resuspension volume is 35 µL with nuclease free water.
* Use of these extraction methods with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel as set forth above is authorized under the CDC's EUA.
^ The instruments in these extraction methods are referenced in the instructions for use for the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel, but the methods described above vary from the methods described in those instructions. Thus, such uses are outside the scope of and not authorized under the EUA.
˜ Use of these extraction methods with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel is not authorized under the CDC's EUA.
A: Below is information regarding certain instruments and the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. We note that use of these instruments with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel is not authorized, but FDA understands that there is information available to support use of these instruments with this test.
The following instruments are designed to detect RNA viruses, and are FDA cleared in K190302 for the CDC's RNA-based influenza panel:
- Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument with SDS software version 1.4
- Applied Biosystems™ QuantStudio™ Dx with version 1.0.3 software
- QIAGEN Rotor-Gene Q MDx with AssayManager version 1.0.4.1 and Epsilon version 1.0.1 software
Independent validation studies were conducted on the following instruments with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel:
- Applied Biosystems™ 7500 Fast Real-Time PCR Instrument with SDS software version 1.4
- Applied Biosystems™ QuantStudio™ 6 Flex Real-Time PCR System with version 1.1 software
A: Below is information regarding positive control material. Links provided are for information purposes only and are not a recommendation by FDA to use that product. FDA encourages other suppliers of test materials to email COVID19DX@fda.hhs.gov to discuss whether materials they have available may also be appropriate for use. Please note that these materials are not international standard materials.
For control material specific to the authorized CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, please refer to its Instructions For Use.
Control material for other EUA RT-PCR tests is available from the following resources:
- Inactivated virus:
- BEI Resources: Order through BEI Resources website
- 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
- ATCC: Order through their website
- Product # VR-1986HK: Heat-inactivated SARS-CoV-2 (strain 2019-nCoV/USA-WA1/2020)
- ZeptoMetrix: Order by emailing custserv@zeptometrix.com OR calling customer service at 1-800-274-5487 OR through their website
- Product # NATSARS(COV2)-ERC: NATtrol SARS-Related Coronavirus 2 (SARS-CoV-2) External Run Control (6 X 0.5mL)
- This product contains approximately 50,000 copies/mL. The isolate is USA-WA1/2020, chemically inactivated.
- Product # NATSARS(COV2)-ST: NATtrol SARS-Related Coronavirus 2 (SARS-CoV-2) Stock (1mL)
- This product contains approximately 1,000,000 copies/mL. The isolate is USA-WA1/2020, chemically inactivated.
- Product # NATSARS(COV2)-ERC: NATtrol SARS-Related Coronavirus 2 (SARS-CoV-2) External Run Control (6 X 0.5mL)
- Vircell (Vircell US distributor is BioDominium Diagnostics): Order by emailing service@biodominium.com OR calling customer service at (305) 668-7667 OR fax request to (305) 370-3151
- Product # MBTC030-R: Amplirun TOTAL SARS-CoV-2 CONTROL (SWAB)
- This product contains a heat-inactivated Spanish clinical isolate of SARS-CoV-2 (strain EPI_ISL_429256) that was diluted in Universal Transport Media and spiked with human epithelial cells prior to lyophilization. Please note, this product does not contain swabs. The genome is available.
- Product brochure
- Product # MBTC030-R: Amplirun TOTAL SARS-CoV-2 CONTROL (SWAB)
- BEI Resources: Order through BEI Resources website
- Extracted viral genomic RNA: Viral genomic RNA may be acquired through extraction of SARS-CoV-2 positive patient samples or acquired through commercial sources.
- BEI: Order through BEI Resources website
- Product # NR-52285: Genomic RNA from SARS-Related Coronavirus 2, Isolate USA-WA1/2020
- ATCC: Order through their website
- Product # VR-1986D: Genomic RNA from Severe acute respiratory syndrome-related coronavirus 2 (strain 2019-nCoV/USA-WA1/2020)
- Product # VR-1992D: Genomic RNA from Severe acute respiratory syndrome-related coronavirus 2 (strain 2019-nCoV/Italy-INMI1)
- Vircell (Vircell US distributor is BioDominium Diagnostics): Order by emailing service@biodominium.com OR calling customer service at (305) 668-7667 OR fax request to (305) 370-3151
- Product # MBC137-R: Amplirun SARS-CoV-2 CONTROL
- This product contains lyophilized RNA from SARS-CoV-2 strain EPI_ISL_429256, a Spanish clinical isolate. The genome is available.
- Product brochure
- Product # MBC137-R: Amplirun SARS-CoV-2 CONTROL
- BEI: Order through BEI Resources website
- Non-encapsulated synthetic full or near full genome length RNA:
- Twist Bioscience: Order following the instructions on the product page
- Product SKU 102019: Twist Synthetic SARS-CoV-2 RNA Control 1 (MT007544.1)
- This is a non-encapsulated product consisting of 6 non-overlapping 5 kb synthetic RNA fragments spanning near the entire viral genome (>99.9%).
- Product SKU 102024: Twist Synthetic SARS-CoV-2 RNA Control 2 (MN908947.3)
- This is a non-encapsulated product consisting of 6 non-overlapping 5 kb synthetic RNA fragments spanning near the entire viral genome (>99.9%).
- Product SKU 102019: Twist Synthetic SARS-CoV-2 RNA Control 1 (MT007544.1)
- Codex DNA: Order by emailing covid19@codexdna.com OR following the instructions on their product page ]
- Product # SC2-RNAC-0100: Synthetic SARS-CoV-2 RNA Controls, non-overlapping
- 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).
- Product # SC2-RNAC-1100: Synthetic SARS-CoV-2 RNA Controls, overlapping
- 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).
- Product # SC2-RNAC-0100: Synthetic SARS-CoV-2 RNA Controls, non-overlapping
- Twist Bioscience: Order following the instructions on the product page
- Encapsulated synthetic RNA:
- SeraCare: Order through their website
- Product # 0505-0168: AccuPlex SARS-CoV-2 Verification Panel
- This product contains recombinant Alphavirus encapsulating a synthetic, full SARS-CoV-2 RNA genome, which is non-infectious and replication-deficient.
- 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."
- Products # 0505-0126 OR # 0505-0159: AccuPlex SARS-CoV-2 Reference Material Kits
- 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).
- 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."
- Product # 0505-0168: AccuPlex SARS-CoV-2 Verification Panel
- Asuragen: Order by emailing armored@asuragen.com OR through their website
- Product # 52030: Armored RNA Quant SARS-CoV-2
- This is an encapsulated product (phage-based), containing targets within the nucleocapsid (N) region. This is also available in its non-encapsulated form upon request.
- Product # 52036: Armored RNA Quant SARS-CoV-2 Panel
- This is an encapsulated product (phage-based), containing targets within the nucleocapsid (N), envelope (E), RNA-dependent RNA polymerase (RdRp), Open Reading Frame sequence (ORF1), and human RNase P regions.
- Product # 52030: Armored RNA Quant SARS-CoV-2
- SeraCare: Order through their website
- Non-encapsulated synthetic RNA:
- Twist Bioscience: Order following the instructions on the product page
- Upon request, Twist Bioscience can manufacture synthetic SARS-CoV-2 RNA controls for any new strains as they evolve.
- Codex DNA: Order by emailing covid19@codexdna.com
- Upon request, Codex DNA can manufacture desired synthetic DNA and RNA constructs to support customers' COVID-19 related needs.
- Microbiologics: Order by emailing INFO@microbiologics.com OR through their website
- 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)
- ATCC: Order through their website
- 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'
- Exact Diagnostics: Order through their website
- Product # COV019: Exact Diagnostics SARS-CoV-2 Standard
- This product contains targets within the E/N/S/ORF1ab/RdRp regions.
- Product # COV019: Exact Diagnostics SARS-CoV-2 Standard
- European Commission: Order through their website
- Product # EURM-019: Single stranded RNA (ssRNA) fragments of SARS-CoV-2
- Please note this product sequence has been verified for use with the N1 and N2 gene targets developed by the Centers for Disease Control and Prevention (USA), the E gene and the RdRP gene targets developed by the Charité, and the S gene target developed by the Joint Research Centre of the European Commission.
- Product # EURM-019: Single stranded RNA (ssRNA) fragments of SARS-CoV-2
- Thermo Fisher Scientific: Order through their website
- Product # 954519: AcroMetrix™ Coronavirus 2019 (COVID-19) RNA Control
- This control plasmid contains in vitro transcribed RNA containing the N, S, E and Orf1ab regions.
- Product # 954519: AcroMetrix™ Coronavirus 2019 (COVID-19) RNA Control
- Maine Molecular Quality Controls: Order by emailing info@mmqci.com OR through their website
- Product # M441: BioFire RP2.1/RP2.1plus Control Panel M441
- This product is intended for use with BioFire RP2.1 and BioFire RP2.1plus assays. It contains gene segments from the S, E, M, ORF8, and N genes.
- Product # M430: Xpert SARS-CoV-2 Control Panel M430
- This product is intended for use with Xpert Xpress SARS-CoV-2 assay on the GeneXpert Systems (Cepheid). It contains segments from the RdRp, E, and N (including both N1/N2 targets) genes.
- Product # M441: BioFire RP2.1/RP2.1plus Control Panel M441
- Twist Bioscience: Order following the instructions on the product page
- 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.
- IDT: Order through their website
- Product # 10006625: 2019-nCoV_N_Positive Control
- This product contains the nucleocapsid (N) region, including the N1/N2 targets for the CDC EUA design.
- Product # 10006625: 2019-nCoV_N_Positive Control
- Codex DNA: Order by emailing covid19@codexdna.com OR following the instructions on their product page
- Product # SC2-FLSG-0000: SARS-CoV-2 full-length genome
- A SARS-CoV-2 full-length, synthetic genome (Wuhan-Hu-1 strain; GenBank number MN908947.3), cloned in a bacterial artificial chromosome. Genome modifications and editing are available.
- Product # SC2-FLSG-1111: SARS-CoV-2 full-length genome with T7 promoter
- 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. Genome modifications and editing are available.
- Product # SC2-FLSG-0000: SARS-CoV-2 full-length genome
- IDT: Order through their website
- RNase P controls:
- Human RNA can be extracted from human specimens or cultured human cells and used directly as the RP positive control.
- Microbiologics: Order by emailing INFO@microbiologics.com OR through their website
- Product # HE0058N: Helix Elite Inactivated Standard (Negative Cellularity Control)
- Each pellet contains A549 lung epithelial cells.
- Product # HE0058N: Helix Elite Inactivated Standard (Negative Cellularity Control)
- Asuragen: Order by emailing armored@asuragen.com OR through their website
- Product # 52031: Armored RNA Quant RNAase P
- This is an encapsulated product (phage-based). This is also available in its non-encapsulated form upon request.
- Product # 52031: Armored RNA Quant RNAase P
- IDT Order through their website
- Product # 10006626: Hs_RPP30 Positive Control
- This product is a DNA plasmid containing a portion of the RPP30 gene.
- Product # 10006626: Hs_RPP30 Positive Control
A: Human RNA can be extracted from human specimens or cultured human cells and used directly as the Human Specimen Control (HSC) control. This RNA extraction procedural control is used to demonstrate successful recovery of RNA as well as extraction reagent integrity. The HSC should yield a positive result with the RP primer and probe set and negative results with all 2019-nCoV markers.