Catalog # 2019-nCoVEUA-01
1000 reactions
For In-vitro Diagnostic (IVD) Use
Rx Only
Intended Use
The CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals who meet 2019-nCoV clinical and/or epidemiological criteria (for example, clinical signs and symptoms associated with 2019-nCoV infection, contact with a probable or confirmed 2019-nCoV case, history of travel to geographic locations where 2019-nCoV cases were detected, or other epidemiologic links for which 2019-nCoV testing may be indicated as part of a public health investigation). Testing in the United States is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.
Results are for the identification of 2019-nCoV RNA. The 2019-nCoV RNA is generally detectable in upper and lower respiratory specimens during infection. Positive results are indicative of active infection with 2019-nCoV but do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Testing with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel is intended for use by trained laboratory personnel who are proficient in performing real-time RT-PCR assays. The CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel is only for use under a Food and Drug Administration’s Emergency Use Authorization.
Summary and Explanation
An outbreak of pneumonia of unknown etiology in Wuhan City, Hubei Province, China was initially reported to WHO on December 31, 2019. Chinese authorities identified a novel coronavirus (2019-nCoV), which has resulted in thousands of confirmed human infections in multiple provinces throughout China and many countries including the United States. Cases of asymptomatic infection, mild illness, severe illness, and some deaths have been reported.
The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel is a molecular in vitro diagnostic test that aids in the detection and diagnosis 2019-nCoV and is based on widely used nucleic acid amplification technology. The product contains oligonucleotide primers and dual-labeled hydrolysis probes (TaqMan®) and control material used in rRT-PCR for the in vitro qualitative detection of 2019-nCoV RNA in respiratory specimens.
The term “qualified laboratories” refers to laboratories in which all users, analysts, and any person reporting results from use of this device should be trained to perform and interpret the results from this procedure by a competent instructor prior to use.
Author(s): Centers for Disease Control and Prevention
Series: Catalog # 2019-nCoVEUA-01 1000 reactions
Publisher: Centers for Disease Control and Prevention
Year: 2020
Language: English
Tags: Novel Coronavirus; Covid-19 Diagnostic Testing
Attachment B_CDC Instructions for Use 15Mar20
Instructions for Use
Catalog # 2019-nCoVEUA-01
For In-vitro Diagnostic (IVD) Use
Rx Only
Table of Contents
Intended Use
Summary and Explanation
Principles of the Procedure
Summary of Preparation and Testing Process
Materials Required (Provided)
Materials Required (But Not Provided)
Equipment and Consumables Required (But Not Provided)
Warnings and Precautions
Reagent Storage, Handling, and Stability
Specimen Collection, Handling, and Storage
Specimen Referral to CDC
The emergency contact number for CDC Emergency Operations Center (EOC) is
770-488-7100.
Reagent and Controls Preparation
General Preparation
Equipment Preparation
Nucleic Acid Extraction
Qiagen QIAamp® DSP Viral RNA Mini Kit or QIAamp® Viral RNA Mini Kit
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
Recommendation(s): 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.
Kit: Qiagen EZ1 Virus Mini Kit v2.0 and Buffer AVL (supplied separately) for offboard lysis
Card: EZ1 Advanced XL Virus Card v2.0
Recommendation(s): 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.
Equivalence and performance of the following extraction platforms were demonstrated with the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (K190302) and based on those data are acceptable for use with the CDC 2019-nCoV Real-Time RT-PCR D...
Assay Set Up
Create a Run Template on the Applied Biosystems 7500 Fast Dx Real-time PCR Instrument (Required if no template exists)
Passive reference should be set to “(none)” as described above.
Defining the Instrument Settings
Running a Test
Data Analysis
Interpretation of Results and Reporting
2019-nCoV rRT-PCR Diagnostic Panel Results Interpretation Guide
Quality Control
Limitations
Conditions of Authorization for the Laboratory
Performance Characteristics
Analytical Performance:
Specimen Stability and Fresh-frozen Testing:
Clinical Performance:
Disposal
References
Revision History
Contact Information, Ordering, and Product Support
For technical and product support, contact the CDC Division of Viral Diseases directly.
Attachment C_CDC Product Information Sheet 15MAR2020
CATALOG: 2019-nCoV EUA-01
KIT LOT:
Attachment D_CDC Verification Requirements 15MAR2020 updated
CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel – Verification Requirements
INTENDED USE
The CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens (such as nasopharyngeal or oroph...
Results are for the identification of 2019-nCoV RNA. The 2019-nCoV RNA is generally detectable in upper and lower respiratory specimens during infection. Positive results are indicative of active infection with 2019-nCoV but do not rule out bacterial...
Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological infor...
