RT-PCR COVID-19 Testing Kit

Intended Use

The Covid-19 RT-PCR Mix Kit is a real-time multiplex RT-PCR testintended for the qualitative detection of SARS-CoV-2 viral RNA. It issuitable for upper respiratory specimens, such as nasopharyngeal,oropharyngeal swab, andbronchoalveolar lavage specimens. In asingle RT-PCR reaction, it is able to detect ORF1ab and N RNAsequences, and in addition, human RNase P as an internal control.

1. Diagnosing whether individuals are infected with the COVID-19 virus

• Clinical diagnosis: In hospitals or professional medical institutions, these kits are used to test patients with symptoms of COVID-19 infection (such as fever, cough, and dyspnea). Medical staff collect samples such as nasopharyngeal swabs, oropharyngeal swabs, or sputum from patients. Through the RT-PCR technique, it can detect whether the RNA of the COVID-19 virus exists in the samples. If the test result is positive, combined with clinical symptoms and other examinations, the patient can be diagnosed as being infected with the COVID-19 virus, thus providing a basis for subsequent isolation and treatment.
• Large-scale screening: During the outbreak of the epidemic or in high-risk areas, these kits are used for large-scale screening of the population. For example, at transportation hubs such as airports and ports, they are used to test incoming personnel; or in centralized places such as communities, schools, and enterprises, they are used to conduct rapid tests on a large number of people so as to detect potential infected individuals in a timely manner and control the spread of the virus. Such large-scale screening helps to quickly cut off the transmission route and contain the spread of the epidemic at the early stage of the epidemic or during local outbreaks.

2. Monitoring the epidemic dynamics

• Monitoring the infection rate: By regularly conducting RT-PCR tests on the population in a specific area, the COVID-19 infection rate in that area can be calculated. The infection rate data is crucial for assessing the severity of the epidemic, predicting the trend of the epidemic, and formulating public health policies (such as implementing lockdown measures and adjusting social distancing requirements). For example, when the infection rate in an area continues to rise, it may be necessary to strengthen prevention and control measures; conversely, when the infection rate drops and remains at a low level, restrictions can be appropriately relaxed.
• Monitoring virus mutations: The COVID-19 virus may mutate during the process of transmission. The RT-PCR COVID-19 detection kits can detect the viral RNA of different variants. Through the detection of a large number of samples and the analysis of gene sequences, the mutation of the virus can be tracked. This is of great significance for understanding the evolutionary trend of the virus and evaluating the impact of variants on the effectiveness of vaccines and the severity of the disease. For example, when a new variant with stronger transmissibility or pathogenicity is discovered, it is necessary to adjust prevention and control strategies and the direction of vaccine research and development in a timely manner.

3. Evaluating the treatment effect

• Monitoring patient recovery: During the treatment of COVID-19 patients, regularly using RT-PCR detection kits to test patient samples can monitor the changes in the viral load in patients’ bodies. As the treatment progresses, if the test result changes from positive to negative and the patient’s clinical symptoms improve, it usually indicates that the patient is recovering. This helps doctors judge the effectiveness of the treatment plan and decide whether the patient can be discharged from the hospital or released from isolation.
• Evaluating drugs and therapies: When researching the treatment effects of new drugs or treatment methods on COVID-19 infection, RT-PCR detection can be used as an important evaluation means. By comparing the changes in the viral RNA levels before and after treatment in patient groups using different drugs or therapies, it can be determined which drug or therapy is more effective, providing a scientific basis for clinical treatment.