COVID-19 RT-PCR Kit
RealDetect COVID-19 RT-PCR Kit is an in vitro diagnostic medical device for qualitative detection of coronavirus disease (COVID-19) from RNA extracted from human nasopharyngeal swab using real-time RT-PCR (Reverse Transcription Polymerase Chain Reaction). The results can be used to assist diagnosis of patients with COVID-19 infection and provide molecular diagnosis basis for infected patients.
Kit Features
– Design of the kit as per CDC/WHO recommended protocol.
– Detection Target Gene : N1 and N2 gene as well as RNase P gene as internal control of SARS-CoV-2.
– Highly Sensitive and Specific; able to detect 01 copy per reaction.
– Fast protocol: Reaction time within 72 minutes.
– Inclusion of internal control for quality check throughout the procedure.
– Low contamination risk, no post-PCR product handling.
– One tube reaction for identification and detection of SARS-CoV-2.
– Provide all reagents required for PCR.
What is COVID-19
COVID-19 has emerged as a life threatening disease caused by the novel coronavirus (SARS-CoV-2) which belongs to the Coronaviridae family and causes severe acute respiratory illnesses in humans. Since its discovery on December, 2019 in Wuhan, China, the fast spreading Covid-19 has infected and claimed millions of lives throughout the world which has made it essential to detect this deadly virus at an exponential pace.
Coronaviruses (CoVID-19) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronavirus disease (COVID-19) is a new strain that was discovered in 2019 and has not been previously identified in humans.
Specifications
| Target Analyte: | Specific region of N1 and N2 gene of 2019- Novel CoV |
| Specimen type: | Nasopharyngeal swab |
| Sample volume: | 9.5 µL extracted RNA |
| Storage: | Below -20ᵒ c |
| Shelf-life: | 6 months |
| Reaction time: | 72 minutes |
| Internal control: | Endogenous internal control included |
| Quality control: | Positive control, negative control |
| Detection Channel: | FAM, ROX, VIC |
| Kit size: | 50/100 tests per kit |
Performance
| Confirm by Sansure COVID-19 RT-PCR Test Kit | |||
| Positive | Negative | ||
| RealDetect COVID-19 RT-PCR Test Kit | Positive | 60 | 0 |
| Negative | 0 | 60 | |
Sensitivity of RealDetect COVID-19 RT-PCR Kit Test : 100%
Specificity of RealDetect COVID-19 RT-PCR Kit Test : 100%
Performance Evaluation Study done by Institute for developing Science & Health initiative (ideSHi);
Compatibility
- Applied Biosystem (ABI) 7500 Real Time PCR Instrument System (Thermo Fisher Scientific)
- QuantStudio 3 Real-Time PCR System (Thermo Fisher Scientific)
- QuantStudio 5 Real-Time PCR System (Thermo Fisher Scientific)
- CFX96 Touch Real-Time PCR Detection System (Bio-Rad)
Key Components
- Master Mix
- Primer Probe Mix
- Positive control
- Nuclease-free water
Order Information
| Product name | Cat No. | Pack Size |
| RealDetect COVID-19 RT-PCR Kit | M02-06-72 | 50/100 tests per kit |