1. Expected use
The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probe) is a real-time RT PCR test intended for the qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, middle turbinate swabs, nasal washes, and nasal aspirates from individuals suspected of having SARS-CoV-2. COVID19 by your health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform stop complexity tests.
The results are for the identification of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in respiratory samples during the acute phase of infection. The positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with the patient’s history and other diagnostic information is needed to determine the patient’s infection status. The positive results do not rule out bacterial infection or co-infection with other viruses. The detected agent may not be the ultimate cause of the disease. Laboratories within the United States and its territories must report all positive results to the appropriate public health authorities.
Negative results do not exclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results should be combined with clinical observations, patient history and epidemiological information. The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probe) is intended for use by trained and qualified clinical laboratory personnel specifically instructed and trained in real-time PCR techniques and in vitro diagnostic procedures. The novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probe) is only for Use under the Emergency Use Authorization (EUA) of the Food and Drug Administration.
2. Product Overview/Testing Principle
During the 2019-nCoV pneumonia epidemic that occurred in China, Sansure Biotech developed a fast and simple NAT kit based on its advanced rapid RNA release technology. The novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time reverse transcriptase-polymerase chain reaction (RRT-PCR) test. The 2019-nCoV primer and the probe sets are designed to detect SARS-CoV-2 RNA in patient respiratory samples who are suspected of having COVID-19 by their healthcare provider.
This kit is used for qualitative two detections of the ORF1ab and N genes of the SARS-CoV-2 RNA. With simple step centrifugation and lysis, the sample mixture can be added directly to the 2019-nCoV-PCR master mix (2019-nCoV-PCR Mix + 2019-nCoV-PCR-Enzyme Mix) to perform RRT-PCR amplification. The QIAamp Viral RNA Mini Kit (50, Cat #52904) can be used as an alternative extraction method Internal control targeting the RNase P gene monitors sample collection, sample handling and RRT-PCR process to avoid false-negative results.
The LoD of the kit is 200 copies/mL. The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probe) is a real-time reverse transcriptase-polymerase chain reaction (RRT-PCR) test. The 2019-nCoV primer and probe sets are designed to detect SARS-CoV-2 RNA in respiratory samples of patients with signs and symptoms of suspected COVID-19 infection.
3. Stability and transport of reagents
The diagnostic kit (in a small box) should be stored at -20±5℃ in the dark and should be Shipped in a sealed foam box with ice packs. The sample storage reagent (in large and white size) box) should be stored and transported at room temperature or 2 – 8 ℃ or lower. The team must be stored at -20±5℃. Unpackaged kits should avoid repeated freeze-thaw cycles.
4. Consumables not supplied:
- Clean samples with a synthetic tip, such as nylon or Dacron®, and an aluminium or plastic tip axis.
- Eppendorf tube free of DNase and RNase of 1.5 ml
- 0.2 ml PCR tube or strip
- Various models of pipettes and pipette tips (10 μL, 200 μL and 1000 μL tips with filters)
- Centrifuge (can reach up to 12,000 rpm)
- desktop vortex mixer
- 0.9% saline solution
- -20℃ cold blocks
- 10% bleach
- DNAZapTM (Ambion, catalog no. AM9890)
- Powder-free disposable gloves and surgical gowns
5. Control materials
2019-nCoV-PCR-Negative Control: A “no template” (negative) control is used to monitor if there is contamination for the RRT-PCR process and is used in each detection series.
2019-nCoV-PCR-Positive Control: A positive template control is used to monitor whether the RRT-PCR process works correctly and is used in each detection series.
Internal control for the RNase P gene is used to monitor the harvesting, handling, and RRT-PCR process and is used in each sample amplification.
6. Collection, storage and transport of samples
- Equipment preparation
Clean and decontaminate all work surfaces, pipettors, centrifuges, and other equipment before use. Decontamination agents such as 10% bleach, 70% ethanol, and DNAzap™ should be used to minimize the risk of nucleic acid contamination.
- Sample collection
The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probe) is intended for the qualitative detection of SARS-CoV-2 nucleic acid in respiratory tract specimens Collection should avoid possible contamination in the collection, storage and transportation. The specimen must be presumed contagious and handled in accordance with applicable regulations. Collection swabs should have a synthetic tip, such as nylon or Dacron®, and an aluminium or aluminium tip plastic shaft.
Calcium alginate swabs are unacceptable and wooden-handled cotton swabs are not acceptable not recommended. After sample collection, the swabs should be stored in the sample storage reagent immediately. By using the sample storage reagent provided by the manufacturer, the user is capable of directly lysing the sample using the rapid RNA release technology of the sample release reagent provided in this kit.
- Storage and delivery of specimens:
Samples can be processed immediately. Samples must be tested within 24 hours if stored in 4℃ Specimens that cannot be tested within 24 hours should be stored at -70℃ or lower (in the absence of -70 ℃ storage conditions, samples can be stored at -20 ℃ for 10 days, the nucleic acid can be stored at -20±5 ℃ for 15 days). Multiple freeze/thaw cycles should be avoided. specimens must be shipped in an ice-sealed frozen pitcher or ice-sealed foam box.