Mycoplasma pneumoniae nucleic acid detection kit (PCR-fluorescent probe method)

Mycoplasma pneumoniae (M. Pneumonia, MP) is the pathogen of human mycoplasma pneumonia. The pathological changes of mycoplasma pneumonia are mainly interstitial pneumonia, sometimes complicated by bronchial pneumonia, which is called primary atypical pneumonia. Worldwide, multiple studies have shown that the annual MP infection rate is 9.6% to 66.7%, the infection rate during non-epidemic period is 10% to 20%, and MP accounts for more than 30% of pediatric pneumonia during epidemic period. There are approximately 156 million children with pneumonia each year, of which 151 million children with pneumonia occur in developing countries and are the leading cause of death for children under 5 years of age, accounting for 19% of the total number of deaths. It is also the main cause of death among adults, especially among the elderly.
Mainly infected by droplets, the incubation period is 2 to 3 weeks, and the incidence is the highest among adolescents. The clinical symptoms are mild, or even asymptomatic at all, and if there are only general respiratory symptoms such as headache, sore throat, fever, cough, etc., but there have been individual death reports. It can happen all year round, but mostly in autumn and winter.

Based on real-time fluorescence PCR technology, rapid detection, accurate and reliable results.
The reaction system of this kit contains a dU-UNG enzyme anti-pollution system to avoid false positive results; the system contains internal standards to avoid false negative results.
Taking the highly conserved region of the Mycoplasma pneumoniae genome as the target region, specific primers and fluorescent probes are designed to perform PCR amplification to ensure the accuracy of the product.
Carry out big data clinical verification covering national representative clinical units, with outstanding product performance.

Mycoplasma pneumoniae nucleic acid detection kit (PCR-fluorescent probe method)
Sensitivity	5.0x103copies / mL
Linear range	1.0x104copies / mL ~ 1.0x 109copies / mL
Accuracy	With reference to international reference products, the coincidence rate of the test results is 100%
Precision	Coefficient of variation within and between batches CV≤5%
Specificity	100% specificity, no cross reaction with Streptococcus pneumoniae, Mycobacterium tuberculosis, Epstein-Barr virus, pertussis virus, adenovirus, respiratory syncytial virus, etc.
Anti-interference	Mucin, blood, pus, erythromycin, chloramphenicol did not interfere with the test results

Figure 1: Using 1x104copies / mL reference as a template, repeat the 20-well test in the same batch, calculate the coefficient of variation of the CT value in the batch, and the CV value is ≤5%, with good consistency.
Figure 2: For the reference products in the concentration range of 107-104 copies / mL, the product amplification curve is smooth and complete, and the correlation coefficient between different gradients is R> 99%, and the correlation is good.

For clinical diagnosis of mycoplasma pneumonia
Suitable for pediatrics, infections, ENT, etc.
For sore throat, dry cough, fever or paroxysmal irritable cough, cough a small amount of mucus or mucopurulent sputum
Sometimes patients with bloody sputum and other symptoms undergo laboratory diagnosis of Mycoplasma pneumoniae
It is used to distinguish the respiratory tract infections of viral or bacterial, mycoplasma, chlamydia, and provides a plan for clinical medication

Test specimen: throat swab
Technical principle: PCR-fluorescent probe method
Packing specification: 25 tests/ kit
Category: In vitro diagnostic reagents
Applicable instruments: fluorescence quantitative PCR instrument