The UW Clinical Virology Laboratory in the Department of Laboratory Medicine and Pathology incorporates six assays for the detection of the COVID-19 virus (SARS-CoV-2) RNA. Obstetric patients following OB/GYN guidelines (rapid testing for family members is not allowed). 6 29 genesig® Real-Time PCR Coronavirus COVID-19 (CE) Z-Path-COVID-19-CE-IFU Issue 3.0 Published Date: 13 Mar 2020 Primerdesign Ltd 6. DiaSorin SpA LIAISON®SARS-CoV-2 S1/S2 IgG (US FDA EUA - Health Canada - Brazil ANVISA - … Testing supplies are very limited. If transport media is not available, place dry swabs in 2-3mL of PBS/sterile saline. It has been evaluated by the FDA and CDC and granted Emergency Use Authorization. Amplification of both targets results in a presumptive positive (detectable) test result, while amplification of one of two targets results in an inconclusive result, and … Remove swab and repeat the same process in the other nostril with the same swab. Amplification of both targets results in a presumptive positive (detectable) test result, while amplification of one of two targets results in an inconclusive result, and amplification of neither target results a negative (non-detectable) test result. Simplexa COVID-19 Direct and Simplexa COVID-19 Positive control Pack: MOL4150, MOL4160 DiaSorin: 23 June 2020 Xpert Xpress SARS-CoV-2: XPRSARS-COV2-10 Cepheid AB: 15 June 2020 COVID-19 Real-Time PCR Kit: HBRT-COVID-19 Chaozhaou Hybribio Biochemistry Ltd. 11 June 2020 Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Real Time PCR) Orders for rapid COVID-19 testing can be placed in Soarian and PulseCheck. Instructions for Nasopharyngeal Swab: Gently insert mini-tipped flocked nasopharyngeal swab (swab on flexible plastic shaft) through the nostril and into the nasopharynx, reaching the posterior nasopharynx. CSF, Sputum, stool, plasma, and BAL are also acceptable specimens for the UW SARS-CoV-2 Real-time RT-PCR assay. This is available on request. The Hologic Emergency Use Authorization (EUA) SARS-CoV-2 Real-time RT-PCR assay targets two conserved regions of the SARS-CoV-2 (the causative agent for COVID-19) ORF1ab gene. Detection of just the E nucleic acid target is considered a presumptive positive result and additional confirmatory testing may be needed. Positive results are indicative of active infection. We currently cannot accept at-home collected swabs and await further FDA guidance on this issue. Simplexa COVID-19 Direct assay RT-PCR Everlywell, Inc. Everlywell COVID-19 Test Home Collection Kit RT-PCR Euroimmun US Inc. EURORealTime SARS-CoV-2 RT-PCR Fast Track Diagnostics Luxembourg S.á.r.l. DiaSorin Molecular announced that it received federal funding from BARDA for its Simplexa COVID-19 direct testing kit. The Simplexa ® COVID-19 Direct kit allows for fast results directly from Negative results do not preclude COVID-19 and should not be used as the sole basis for patient management decisions. Product Description The Coronavirus COVID-19 (CE IVD) genesig® Real-Time PCR assay is an in vitro diagnostic test based on Real-Time PCR technology, developed for specific detection of SARS-CoV-2 viral RNA. These include red-top Greiner "VACUETTE® Virus Stabilization Tubes." SARS-CoV-2 is detected by Real-time RT PCR: see methods for assay details. UW Laboratory Medicine Virology will prioritize maintaining clinically-actionable turnaround time for inpatient settings. Testing can only be performed for the following indications: Pre-op for urgent cases (i.e. For the Hologic Panther Fusion, 500 μl of VTM was transferred to lysis buffer in manufacturer-provided tubes and loaded directly on the instrument. LIAISON® MDX - Simplexa™ COVID-19 Direct Background Characteristics The DiaSorin Molecular Simplexa™ COVID-19 Direct real-time RT-PCR assay is intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection of nucleic acid from severe PLEASE NOTE: This is a Professional Use Only product that requires a trained operator in a controlled laboratory environment. The U.S. Centers for Disease Control, or C.D.C., is a government organization based in Atlanta, GA.The organization’s CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel was the first coronavirus test approved for use in the U.S., and should be used with the Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS 1.4 software. Do not freeze/thaw. OF THE KPMAS COVID-19 TEST USED WITH THE KPMAS COVID-19 The SARS-CoV-2 RNA is generally detectable in naso-/oropharynx during the acute phase of infection. If lower respiratory tract specimens are available such as BAL or sputum, they should be sent as they have a greater chance of detecting the virus. The ordering provider will contact the COVID Operations Nurse to request COVID testing (COVID Ops RN to triage need for in-house rapid test vs. sent to UW Virology). The DiaSorin Molecular Simplexa™ COVID-19 Direct Emergency Use Authorization (EUA) SARS-CoV-2 Real-time RT-PCR assay targets two regions of the SARS-CoV-2 (the causative agent for COVID-19) genome, the OEF1ab gene and S gene. Real-time RT-PCR (DiaSorin Molecular Simplexa™ COVID-19 Direct kit). Our latest RUO kit, the Luna ® SARS-CoV-2 RT-qPCR Multiplex Assay Kit, enables high throughput workflows for real-time detection of SARS-CoV-2 nucleic acid using hydrolysis probes. This enables faster turnaround times to help improve patient management and prevent further transmission of the disease. Refer to the specimen collection guidelines. Tube number for the patient's nursing station. Cypress, Calif.-based DiaSorin’s undisclosed funding total … Place order in ORCA, Epic, or Sorian using "COVID-19 Coronavirus Qualitative PCR" per routine. FDA Emergency Use Authorization. The two regions are not differentiated; amplification of either or both regions is a presumptive positive (detectable) test result and amplification of neither target results a negative (non-detectable) test result. sample available < 8-10 hours prior to case), Patient discharging from ED to congregated facilities (students in dorms, homeless, rehab, etc). Negative percent agreement: 100%. The clinical indication field is required when ordering the test. • The genesig Real-Time PCR Coronavirus (COVID-19) CE IVD component “Kit Resuspension Buffer” contains EGTA. Inpatients (including Psychiatry and Rehabilitation) with new symptoms consistent with COVID-19, Patients in the Psychiatric Emergency Department (PES), Patients living homeless who will be discharged from the ER, Inpatients requiring urgent (≤ 12 hrs) pre-operative/pre-procedural screening prior to aerosol-generating procedures (AGP), Inpatients to be discharged within 12 hrs to a SNF that requires COVID-19 testing, Patients to be enrolled in a research protocol that requires time-sensitive documentation of COVID-19. All assays are intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs and nasal swabs. Instrument run time = 75 minutes + setup and resulting. Transport and store tube at 2 to 25°C for up to 48 hours. Many of these measures critically depend on the timely and accurate diagnosis of virus-infected individuals. Positive percent agreement: 100%. Stability: stable for 72 hours 2 to 8°C. Amplification of either or both regions is a positive (detectable) result. Remove swab and repeat the same process in the other nostril with the same swab. Leave swab in place for 2-3 seconds then rotate completely around for 10-15 seconds. FTD SARS-CoV-2 RT-PCR Fosun Pharma USA Inc. Fosun COVID-19 RT-PCR Detection Kit RT-PCR Fulgent Therapeutics, LLC Lab will tube a special requisition slip to the ordering location. Simplexa ™ Molecular Assays. Use is limited to the following areas: Testing performed every 2hrs on the even hour, 24/7. Real-time reverse transcription polymerase chain reaction (RT-PCR) is the most sensitive and specific assay and therefore preferred [2,3]. The DiaSorin Molecular Simplexa™ COVID-19 Direct assay system is a real-time RT-PCR system that enables the direct amplification of Coronavirus SARS-CoV-2 RNA from nasopharyngeal swabs (NPS), nasal swabs (NS), nasal wash/aspirate (NW) or bronchoalveolar lavage (BAL) specimens. Ship immediately to lab at 2-8°C (ice pack). Objectives: Comparative assessments of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular assays that have been operationalized through the US Food and Drug Administration's Emergency Use Authorization process are warranted to assess real-world performance. Disease resolution. Sample may be stored at 2-8°C for up to 72 hours of collection. Other Locations (eg, reference laboratory client), Send all samples with the COVID-19 Test Requisition (form is a fillable pdf - please download and enter information before printing). A 50-μl volume of Simplexa COVID-19 Direct kit reaction mix (MOL4150) was added to the “R” well of the 8-well d irect a mplification d isc (DAD) followed by addition of 50 μl of nonextracted nasopharyngeal swab (NPS) sample to the “SAMPLE” well. patients with no history who cannot give history/overdoses. After the second swab is completed, immediately place into the sterile vial containing media (UTM is preferred). Real-time RT-PCR was set up on 5 μl of eluate using the CDC N1, N2, and RP (or Exo internal control) primers and run on ABI 7500 real-time PCR instruments as reported previously . Obtaining columnar epithelial cells will enhance reliability of viral detection. All processing is done at the performing location. If required, testing will be prioritized based on clinical indication: 1. Write patient name, MRN, ordering physician, patient location, and indication on a requisition form. Negative results must be combined with clinical observations, patient history, and epidemiological information. The DiaSorin Molecular Simplexa™ COVID-19 Direct real-time RT-PCR assay targets two different regions of the SARS-CoV-2 (the causative agent for COVID-19) genome, ORF1ab and S gene. Send to UW Virology Lab via courier. SARS-CoV-2 is detected by using one of the following assays: The UW SARS-CoV-2 Real-time RT-PCR assay targets two distinct regions within the N gene of SARS-CoV-2 (the causative agent for COVID-19). For all questions, contact Client Support Services (available 24/7): Phone: (206) 520-4600 or 1 (800) 713-5198Fax: (206) 520-4903Email: commserv@uw.edu. Amplification of both targets results in a presumptive positive (detectable) test result, while amplification of one of two targets results in an inconclusive result, and amplification of neither target results a negative (non-detectable) test result. Instructions for Sputum: obtain specimen from deep cough (usually in AM), induction or intubation; do not send saliva. LIAISON® MDX - Simplexa™ COVID-19 Direct Background Characteristics The DiaSorin Molecular Simplexa™ COVID-19 Direct real-time RT-PCR assay is intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS- Symptomatic, 3. Contact: commserv@uw.edu | Amplification of both the N2 and E targets or just the N2 nucleic acid target is considered positive. Make sure that the swab is fully immersed in media, and that the shaft is short enough to completely tighten the cap. The Simplexa ™ COVID-19 Direct kit allows for fast results directly from BAL, nasal swab, nasal wash/aspirate, nasopharyngeal swab and saliva specimens, eliminating traditional RNA extraction steps. The laboratory has the capacity for a maximum of 8 rapid tests every 2 hours. The Assay targets the non-structural Polyprotein (pp1ab) of the SARS-CoV-2 … Make sure that the swab is fully immersed in media, and that the shaft is short enough to completely tighten the cap. The Simplexa C. difficile Universal Direct test is performed on liquid or unformed human stool samples and detects the toxin B gene ( tcdB ) of C. difficile , including NAP1. Tubes containing phosphate buffered saline (PBS) will be rejected. The specimen will be hand delivered to the lab with the requisition filled out. UW MedicineDepartment of Laboratory Medicine1959 NE Pacific Street, room NW220Seattle, WA 98195Tel: (206) 520-4600 or 1 (800) 713-5198, Additional information on ordering, collection, and shipment can be found at https://depts.washington.edu/uwviro/order/. Contact: commserv@uw.edu | Leave swab in place for 2-3 seconds then rotate completely around for 10-15 seconds. 39 molecular diagnostic tests: QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAGEN GmbH); NeuMoDx SARS-CoV-2 Assay (NeuMoDx Molecular, Inc.); NxTAG CoV Extended Panel Assay (Luminex Molecular Diagnostics, Inc.); ID NOW COVID-19 (Abbott Diagnostics Scarborough, Inc.); Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV (BGI Genomics Co. Ltd); AvellinoCoV2 test (Avellino Lab USA, … The Cepheid Emergency Use Authorization (EUA) SARS-CoV-2 Real-time RT-PCR assay targets 2 regions of SARS-CoV-2 RNA (the causative agent of COVID-19). This test is an RT-PCR test which looks at the viral load of the COVID-19 virus. The Hologic Emergency Use Authorization (EUA) SARS-CoV-2 Transcripton Mediated Amplification (TMA) assay targets two conserved regions of the SARS-CoV-2 (the causative agent for COVID-19) ORF1ab gene. 95 positive specimens stored in Hanks medium were randomly chosen for direct rRT-PCR in two separate experiments. Oral fluid (OF) is an alternate clinical sample, easy and safer to collect and could be useful for COVID-19 diagnosis, monitoring viral load and shedding. The SARS-CoV-2 … After the second swab is completed, immediately place into the sterile vial containing media (UTM/VTM is preferred; saline is acceptible). 1 . Preprocedural surveillance, 2. KPMAS Regional Laboratory, KPMAS COVID-19 Home Collection Kit 9/9/2020 . Copyright and Disclaimer, SARS-CoV-2 (COVID-19) Qualitative PCR [NCVQLT], SARS-CoV-2 (COVID-19) Qual PCR Specimen Type, SARS-CoV-2 (COVID-19) Qual PCR Interpretation, Frequently Asked Questions About COVID-19 Testing for Providers & Clients, routine COVID-19 PCR test in the Virology laboratory. It is NOT a lateral flow or a Point of Care device designed to be used by the general public. Send to the laboratory as soon as possible. Characteristics such as sensitivity, specificity, and false-negative rate are important to inform clinical use. The DiaSorin Molecular Simplexa™ COVID-19 Direct Emergency Use Authorization (EUA) SARS-CoV-2 Real-time RT-PCR assay targets two regions of the SARS-CoV-2 (the causative agent for COVID-19) genome, the OEF1ab gene and S gene. 7.1.2. genesig Real-Time PCR Coronavirus (COVID-19) CE IVD Please consult the material safety data sheet (MSDS) before using this kit. The Roche cobas Emergency Use Authorization (EUA) SARS-CoV-2 Real-time RT-PCR assay (Fact Sheet) targets two regions of the SARS-CoV-2 (the causative agent for COVID-19) genome, the E gene and ORF1ab gene. November 2020—DiaSorin Molecular received FDA clearance for its Simplexa Flu A/B & RSV Direct Gen II kit. This test provides rapid detection of SARS-CoV-2 (COVID-19) in clinically urgent settings by approval only. Obtaining columnar epithelial cells will enhance reliability of viral detection. Copyright and Disclaimer, https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-detection-instructions.html, https://www.cdc.gov/coronavirus/2019-ncov/index.html, SARS-CoV-2 (COVID-19) Qual PCR Specimen Type, SARS-CoV-2 (COVID-19) Qual PCR Interpretation, COVID-19 Testing Frequently Asked Questions For Patients, COVID Testing for the Hawaii Safe Travels Program, Frequently Asked Questions About COVID-19 Testing for Providers & Clients, Guidance for long term care facilities sending samples for COVID-19 screening, https://depts.washington.edu/uwviro/order/.