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

Mycoplasma pneumoniae nucleic acid dete₩ ction kit (PCR-fluorescent≥♣ε probe method)

Clinical background

Mycoplasma pneumoniae (M. Pneumonia, MP) is tγ≠δhe pathogen of human mycoplasma pne♦∏σ"umonia. The pathological→≥↑≤ changes of mycoplasma β← ✘pneumonia are mainly interstitial pneum™≈"•onia, sometimes complicated by br≥↕↔onchial pneumonia, which is called pri₽¥≤mary atypical pneumonia. Worldwid↑δe, multiple studies have'≥→ shown that the annual MP infection rate&φ"  is 9.6% to 66.7%, the α©↑infection rate during non-epidemic perσσiod is 10% to 20%, and M≥× P accounts for more than 30% of pediatric pneumon ¶ia during epidemic period. There are ÷♣approximately 156 million children>ε←✘ with pneumonia each year, of w±≈÷hich 151 million children with pne♣δ$umonia occur in developing countries and ₽₽σ→are the leading cause of death for chil→€dren under 5 years of age, accounting ≥Ω for 19% of the total number of deaths. It is¶•♣" also the main cause of death among adults, e§×specially among the elderly.
Mainly infected by droplets, the incubati'♣↓>on period is 2 to 3 weeks, an×αφ>d the incidence is the h®♦¶​ighest among adolescents. T✘∏​↓he clinical symptoms are mild, or even asyλπ​mptomatic at all, and if there are only gener‍♥₽☆al respiratory symptoms such as headach↓↔∏‌e, sore throat, fever, cough, etc., bu≥♥↕t there have been inΩ"dividual death reports. It can happen all✔↓≈™ year round, but mostly in autumn and win ​​ter.

Features
Based on real-time fluorescence PCR t∞"β♠echnology, rapid detection, accur≈←ate and reliable results.
The reaction system of this kit co•γntains a dU-UNG enzyme anti-pollution sy₹÷stem to avoid false positive results; the system¶® contains internal standards to ☆λavoid false negative results.
Taking the highly conserved region o₩€λf the Mycoplasma pneumoniae genome as the target α±→‍region, specific primers and f< ¶luorescent probes are des ♠igned to perform PCR amplification to ensure the ™✘λ∞accuracy of the product.
Carry out big data clinical veri™γπ§fication covering national represen" £tative clinical units, with outstanding p¥<roduct performance.
Product performance

Mycoplasma pneumoniae ∑•nucleic acid detection kit (PCR-fluorescent prob ¶↕φe method)

Sensitivity

5.0x103copies / mL

Linear range

1.0x104copies / mL ~ 1.0x 1✔≠09copies / mL

Accuracy

With reference to international reference product×♠←♥s, the coincidence rate of the testπ↕♥​ results is 100%

Precision

Coefficient of variation within and between bat™$∏ches CV≤5%

Specificity

100% specificity, no cross reaction with÷δ♠< Streptococcus pneumoniae, Mycobacterium tubercu←✘↕losis, Epstein-Barr virus, pertussis vi♥₩αδrus, adenovirus, respirator‌↓αΩy syncytial virus, etc.

Anti-interference

Mucin, blood, pus, erythromycin, chloramphenico₩‌l did not interfere with the t‌Ω±‌est results

Sensitivity and linear range


Figure 1: Using 1x104cop♠∞'ies / mL reference as a t‌↑↕εemplate, repeat the 20-well test i₹"→₩n the same batch, calc♥ ≠<ulate the coefficient of variation of the ‌​♥CT value in the batch, and the C£↕₩βV value is ≤5%, with good consistency<γ∑.
Figure 2: For the ref↑ ≠✘erence products in the concentraφ↔×¥tion range of 107-104 copies λα/ mL, the product amplification curve &λis smooth and complete, and the correlation coef✘φ€©ficient between differπ≠ent gradients is R> 99%, and the c≤÷☆orrelation is good.



Application field
For clinical diagnosis of mycoplasma pneumon↓✔ia
Suitable for pediatrics,€<¥₹ infections, ENT, etc.
For sore throat, dry cough, fever or paroxysmaφβε∑l irritable cough, cough a π★small amount of mucus or mucopu​¶£©rulent sputum
Sometimes patients with bloody sputum and oth®∞Ωσer symptoms undergo laboratory diagnosis of Myc☆↓↕oplasma pneumoniae
It is used to distinguish the respiγβratory tract infections of≤δ♠γ viral or bacterial, mycoplasma, chlamydia, an§>★✘d provides a plan for clinical medication
Product information
Test specimen: throat swab
Technical principle: PCR-fluorescent probe method
Packing specification: 25 tests/ kit
Category: In vitro diagnostic reagents
Applicable instrumen♠£ts: fluorescence quantitative PCR instrument