BGI

Real-Time Fluorescent RT-PCR Kit
for Detecting SARS-CoV-2

Product Description

For Emergency Use Authorization Only | For in vitro diagnostic use | Rx Only

On April 24, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) amendment for BGI’s Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2. The amendment expands the previously issued EUA label to further include the use of automated sample preparation system, additional viral RNA extraction kit and PCR systems for testing a broader range of clinical samples. Specifically, viral RNA extraction can be processed by the kits manufactured by MGI (a subsidiary of BGI Group) or Qiagen. In addition, the highly sensitive SARS-CoV-2 detection test can return results within 4 hours for 192 samples collected from throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF) using the MGI automated sample preparation system. Hospitals and reference laboratories can run the test on Roche LightCycler 480 Instrument as well as Applied Biosystems 7500 Fast, 7500 and QuantStudio 5 Real-Time PCR Systems.

Features

  • Taqman™ Reverse Transcription PCR
  • ORF1ab gene as domain target
  • Human β–actin as internal control
  • Manufacturing in ISO 13485 compliant and high-volume production facility
  • Stringent QC with positive and no template controls

Benefits

Highly
Sensitive

Detect as low as 100 viral copies/mL for BALF samples.

Highly
Specific

No cross-reactivity with 54 human respiratory pathogens

High-
throughput

Ramp up labs for large-scale, community-based testing

Fast
TAT

Sample to result in 4 hours with automated sample preparation system.

Ease of
use

All inclusive with pre-mixed reaction reagents

Easy
Interpretation

Analysis of one target with well-
defined controls

Specifications

  • 50 reactions per kit
  • Acceptable samples collected from throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF)
    • Acceptable real-time PCR systems:
    • Applied Biosystems 7500 Fast 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-Well, Software v1.5.1
    • Roche LightCycler 480 Instrument II, 96-Well, Software v1.5.0
  • Acceptable viral RNA extraction kits:
    • MGIEasy Nucleic Acid Extraction Kit, 96 or 1728 preps
    • QIAamp Viral RNA Mini Kit, 50 or 250 preps
  • MGISP-960RS Automated Sample Preparation System, Software v1.2 (Optional)
  • Limit of detection for BALF samples: 100 viral copies/mL
  • Limit of detection for throat swab samples: 150 viral copies/mL
  • Reagents stable under dark for 5 days at 2-8°C or 12 months at -18°C

Key Components

Component Volume Quantity Description
SARS-CoV-2 Reaction Mix
1 µL/vial
1 vial
Reagents for amplification, probes, primers for virus target and internal reference.
SARS-CoV-2 Enzyme Mix
80 µL/vial
1 vial
Taq polymerase, reverse transcriptase, and uracil-DNA glycosylase (UDG).
SARS-CoV-2 Positive Control
750 µL/vial
1 vial
Mix solution of pseudo-virus with target virus genes and internal reference.
SARS-CoV-2 No Template Control
750 µL/vial
1 vial
DNase/RNase free water.

Performance Characteristics

  • 1

Limit of Detection (LoD): 100 copies/mL (BALF); 150 copies/mL (Throat Swabs)

  • 2

Reactivity/Inclusivity: In silico analysis was performed and the assay was mapped to 284 complete SARS-CoV-2 genomes of human host in GenBank and GISAID databases as of March 10th, 2020. Primer and probes sequences for Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 had 100% homology to all SARS-CoV-2 isolates analyzed.

  • 3

Analytical Specificity: Cross-reactivity of the Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 was evaluated using both in silico analysis and by wet testing pathogens. No cross-activity was found in the tested pathogens as shown in the table below.

Intended Use and Emergency Use Authorization Information

The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 is an in vitro diagnostic real-time reverse transcription-PCR assay for the qualitative detection of SARS-CoV-2 nucleic acids in throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF) from individuals who are 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 high complexity tests.

Test results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results 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 SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 is only for use under the Food and Drug Administration’s Emergency Use Authorization.

COVID-19 Inquiries

Products from BGI that are related to COVID-19 are regulated and only available to clinical and diagnostic laboratories. If you are a consumer looking for a COVID-19 test, please see your health care provider for medical advice. For additional COVID-19 information, visit the CDC or WHO sites.

FAQs

BGI Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 and US FDA Emergency Use Authorization (EUA) workflow components.

Go to https://www.bgi.com/us/bgi-covid-19-total-lab-solution/ to see the integrated workflow outlining the instruments and reagents authorized by the FDA to run our assay. The full list of EUA products and protocols can be found from our Instructions for Use at: https://www.fda.gov/media/136472/download.

  • Applied Biosystems 7500 Fast
  • Applied Biosystems 7500
  • Applied Biosystems QuantStudio 5
  • Roche LightCycler 480 Instrument II

Our kit is currently approved for specimen types as follows:

  • Throat (oropharyngeal) swabs
  • Nasopharyngeal swabs
  • Anterior nasal swabs
  • Mid-turbinate nasal swabs
  • Nasal washes
  • Nasal aspirates
  • Bronchoalveolar lavage fluid (BALF)

The kit consists of four vials required for SARS-CoV-2 detection:

  • SARS-CoV-2 Reaction Mix
  • SARS-CoV-2 Enzyme Mix
  • SARS-CoV-2 Positive Control
  • SARS-CoV-2 No Template Control

Customers need to order the whole kit during transactions. We are unable to sell some of the vials in the kit.

  • Clinically tested – Kit validated with large COVID-19 patient cohort
  • Highly sensitive – Detect as low as 100 viral copies/mL for BALF samples
  • Highly specific – No cross-reactivity with 54 human respiratory pathogens
  • Fast turnaround – Sample to result in 4 hours with automated sample preparation system
  • High-throughput – Ramp up labs for large-scale, community-based testing
  • Ease of use – All inclusive with pre-mixed reaction reagents and controls
  • Easy interpretation – Analysis of one target with well-defined controls

The EUA amendment (April 2020) expands the original EUA label (March 2020) and further authorizes the use of the following for SARS-CoV-2 detection by the BGI RT-PCR kit: 1) MGISP-960RS automated sample preparation system (software v1.2), 2) MGIEasy Nucleic Acid Extraction Kit for viral RNA extraction, 3) Five additional human respiratory samples, and 4) Addition of three real-time PCR systems. This total lab solution addresses major bottlenecks in COVID-19 testing by offering high-throughput testing capability, broader clinical adaptability, and abundant supply of MGIEasy Nucleic Acid Extraction Kit.

ORF1ab gene of SARS-CoV-2.

The LoD for throat swab is 150 viral copies/mL.

For BALF, the LoD is 100 viral copies/mL.

The whole workflow for the test would take 3.25 hours from sample to result: automated RNA extraction and PCR master mix preparation for 36 to 96 samples (60 min), RT-PCR setup (15 min), running PCR and performing data analysis (2 hours). This workflow would take approximately 3.68 hours if the number of samples increases to 192.

The whole workflow for the test would take about 3 hours from sample to result if sample preparation is handled manually: RNA extraction and PCR master mix preparation (30-45 min), RT-PCR setup (15 min), running PCR and performing data analysis (2 hours).

Yes. An internal reference control is included. This control targets human beta-actin gene.

Yes. A positive control is provided in the kit. This control contains “pseudo-virus” or virus-like particle in which the synthetic viral RNA target and human beta-actin target in protein are coated separately.

The positive control provided in the kit can serve as an extraction control.

MGIEasy Nucleic Acid Extraction Kit (MGI, catalog# 1000020261 or 1000020471) or QIAamp Viral RNA Mini Kit (Qiagen, catalog# 52904 or 52906).

At least two controls: one positive control and one no template control should be run in each experiment.

The assay uses Taqman™ probes that are designed to anneal to the target sequences. ORF1ab gene of SARS-CoV-2 and human beta-actin will be amplified by primers. The oligonucleotide probes are dual-labeled with a FAM fluorophore attached at the 5’ end and a quencher at the 3’ end. When the fluorophore and the quencher are in proximity, fluorescence signals are inhibited. During PCR extension, the 5’ to 3’ exonuclease activity of Taq polymerase will cleave the probes that have annealed to their target regions. The released fluorophore from the probes are now away and relieved from quenching by the quencher, resulting in fluorescence signals. The FAM channel of the real-time PCR machine is used to detect the ORF1ab gene of SARS-CoV-2 while the VIC/HEX channel is used for detecting the human beta-actin gene.

Ct cutoff of 37 should be used for the FAM channel. For the VIC channel, Ct cutoff of 35 should be used.

Yes. Our kit has been clinically validated. The Instructions for Use (IFU) provides the performance data in details.

Yes. Researchers from the 1) RIVM, the Dutch National Institute for Public Health and the Environment, 2) Foundation For Innovative New Diagnostics (FIND), a WHO Collaborating Centre for Laboratory Strengthening and Diagnostic Technology Evaluation, and 3) Sinai Health System/University of Toronto, have all demonstrated that the BGI kit outperforms the other kits on market with respect to the limit of detection, making our kit particularly useful for detecting samples of low viral loads.

BGI stocks the detection kit at our local warehouses in US and Canada, respectively. We frequently replenish our inventory to meet our customer demand. In addition, the kit is manufactured in our facility with manufacturing capacity of 2 million tests per day.

The kit is shipped with dry ice where the temperature is maintained at approximately -80ºC.

In 2020, our kit received emergency use authorizations or regulatory approvals around the world:

  • Jan 26: Emergency approval from China’s National Medical Products Administration (NMPA)
  • Feb 25: CE-IVD Mark
  • Mar 26: Emergency Use Authorization (EUA) from US FDA
  • Mar 27: Emergency approval from Japan’s PMDA
  • Apr 10: Australian Register of Therapeutic Goods from Australia’s TGA
  • Apr 24: EUA Amendment from US FDA
  • Apr 27: Provisional Authorization from Singapore’s Health Sciences Authority
  • May 4: Importation and Sale Authorization under Interim Order from Health Canada
  • May 7: WHO Emergency Use Listing for IVD detecting SARS-CoV-2

Related information

Contact US

In the United States:

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.

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