Detection Kit for 2019-nCoV (PCR-Fluorescence)
On April 24, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) amendment for BGI’s Real-Time Fluorescent RT-PCR Kit for Detection SARS-CoV-2. The amendment expands the previously issued US label to further include the use of an automated sample preparation system, an additional viral RNA extraction kit, and PCR systems to test a broader range of clinical samples.
Specifically, viral RNA extraction can be processed by kits manufactured by MGI (a subsidiary of BGI Group) or Qiagen. Additionally, the highly sensitive SARS-CoV-2 screening test can return results within 4 hours for 192 samples collected from throat swabs (oropharyngeal), nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, aspirates tubes and bronchoalveolar lavage fluid (BALF) using the MGI automated sample preparation system. Reference laboratories and hospitals can run the test on the Roche LightCycler 480 instrument, as well as the Applied Biosystems 7500 Fast, 7500, and QuantStudio 5 real-time PCR systems.
- Taqman reverse transcription PCR
- ORF1ab gene as domain target
- Human β-actin as an internal control
- Manufactured in high-volume, ISO 13485-compliant production facilities
- Strict quality control with positive controls and no template
- Very sensitive: detects as low as 100 viral copies/ml for BALF samples
- Highly specific: no cross-reactivity with 54 human respiratory pathogens
- High Throughput – Expand labs for large-scale, community-based testing.
- Rapid TAT – sample to result in 4 hours with automated sample preparation system
- Ease of use – all included with premixed reaction reagents
- Easy interpretation: analysis of a target with well-defined controls
● 50 reactions per kit
● Acceptable specimens collected from the throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, middle turbinate nasal swabs, nasal washes, nasal aspirates, and bronchoalveolar lavage fluid (BALF)
● Acceptable real-time PCR systems:
– Applied Biosystems 7500 Rapid Real-Time PCR System, Software v2.0.6
– Applied Biosystems 7500 Real-Time PCR System, Software v2.0.5
– Applied Biosystems QuantStudio 5 Real-Time PCR System, 96 Wells, Software v1.5.1
– Roche LightCycler 480 II instrument, 96 wells, software v1.5.0
● Acceptable viral RNA extraction kits:
– MGIEasy Nucleic Acid Extraction Kit, 96 or 1728 slides
– QIAamp Viral RNA Mini Kit, 50 or 250 slides
● Automated sample preparation system MGISP-960RS, software v1.2 (optional)
● Detection limit for BALF samples: 100 viral copies / mL
● Detection limit for throat swab samples: 150 viral copies/ml
● Reagents stable in the dark for 5 days at 2-8 ° C or 12 months at -18 ° C
Authorization information for the intended use and emergency use
The SARS-CoV-2 Real-Time Fluorescent RT-PCR Kit is an in vitro diagnostic real-time reverse transcription PCR assay for the qualitative detection of SARS-CoV-2 nucleic acids in throat swabs ( oropharyngeal), nasopharyngeal swabs, anterior nasal swabs, middle turbinate swabs, nasal washes, nasal aspirates, and bronchoalveolar lavage fluid (BALF) from people suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC §263a, to perform highly complex testing.
The test results are for the identification of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detected in respiratory samples during the acute phase of infection. Positive results indicate the presence of SARS-CoV-2 RNA; A clinical correlation with the patient’s history and other diagnostic information is necessary to determine the patient’s infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the definitive cause of the disease. Laboratories in 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 SARS-CoV-2 Real-Time Fluorescent RT-PCR Kit is designed for use by trained clinical laboratory personnel specifically instructed and trained in real-time PCR techniques and in vitro diagnostic procedures. The SARS-CoV-2 Real-Time Fluorescent RT-PCR Kit should only be used under the Food and Drug Administration Emergency Use Authorization.
BGI products that are related to COVID-19 are regulated and only available to clinical and diagnostic laboratories. If you are a consumer seeking a COVID-19 test, consult your healthcare provider for medical advice. For additional information on COVID-19, visit the CDC or WHO sites.