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

Mycoplasma pneumoniae nucleε&£®ic acid detection kit (P​§≠®CR-fluorescent probe m♣×σ÷ethod)

Clinical background

Mycoplasma pneumoni→§ae (M. Pneumonia, MP) is the pathogen of human myπ↓coplasma pneumonia. Theδ☆ pathological changes of mycoplasm≈πa pneumonia are mainl×δ'÷y interstitial pneumonia, sometimes complicat¥♥♠₹ed by bronchial pneumonia, which is called≠♣×∏ primary atypical pneumonia. Worldwide, $→&™multiple studies have shown t←®₹hat the annual MP infection rate is ♣¥§9.6% to 66.7%, the infection rat<§e during non-epidemic period is 10×λπ% to 20%, and MP acc±★ounts for more than 30% of pedλ÷✘×iatric pneumonia during epidemic per₽γ$iod. There are approximately 156 Ωγ×million children with pneumonia each year, ♥<←of which 151 million children ♠‌©with pneumonia occur in ≤σ♦developing countries and are the leading cau← ×∏se of death for childr≤λ↓♥en under 5 years of age, accouα♠↕βnting for 19% of the total num↔¥ber of deaths. It is also the m<​ain cause of death among adults, especially aπ$mong the elderly.
Mainly infected by droplets, the incubation perioγ≤∞d is 2 to 3 weeks, and the incidence is the high‌Ω↕est among adolescents. The clinical sy ♠£mptoms are mild, or e←§ven asymptomatic at all, and if t•π$÷here are only general respiratory  •symptoms such as headache, sore throat, f♠ α↕ever, cough, etc., but there ha•¶♦ve been individual dea≠€'th reports. It can happen all year round, but £↓mostly in autumn and winte∑↓✔r.

Features
Based on real-time fluorescence PCR technolo""↓gy, rapid detection, accurate a§δnd reliable results.
The reaction system of this​♥× kit contains a dU-UN¶£€G enzyme anti-pollution system to avoid f ∑€alse positive results; the system contains inte♣®£rnal standards to avoid fals₩✘e negative results.
Taking the highly conserv©¥ed region of the Mycoplasma pneumoniae g¥∏enome as the target region, spec←®↔ific primers and fluorescent probes are de™≈≈signed to perform PCR amplification to ensure the€• accuracy of the product.
Carry out big data clinical verification σ§<₹covering national representativ§£₩​e clinical units, with outstanding product perfσ↕<ormance.
Product performance

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

Sensitivity

5.0x103copies / mL

Linear range

1.0x104copies / mL ~ 1.0x 109copies / mL

Accuracy

With reference to intern >ational reference products, the coincidenδ‍≈ce rate of the test results is 100%

Precision

Coefficient of variation within and betw♣β±¥een batches CV≤5%

Specificity

100% specificity, no cross reaction with Strep♣≈§∑tococcus pneumoniae, M∞¶​‍ycobacterium tuberculosis, Epstein-Barr virus, peσ✔rtussis virus, adenovπ ​'irus, respiratory syncytial virus, etc✘×™<.

Anti-interference

Mucin, blood, pus, erythromycin, chloramphen®£βicol did not interfere with the test results

Sensitivity and linear ran>÷→βge


Figure 1: Using 1x104c₹πopies / mL reference as a template©↔γ≥, repeat the 20-well test in σ$ ←the same batch, calculate the coefficient"‍÷ of variation of the CT value ¶→÷in the batch, and the CV value is ≤5%, with go ↔€od consistency.
Figure 2: For the reference products≈÷≤↑ in the concentration range of 107-104£₽ copies / mL, the prodλ↑uct amplification curve is smooth and complete♣ €, and the correlatio±βεn coefficient between different gradie <nts is R> 99%, and t±" he correlation is good.



Application field
For clinical diagnosis of mycoplasma pneumonia
Suitable for pediatrics, infections, ENT, et©'σ>c.
For sore throat, dry ≠₹cough, fever or paroxysmal irritable cough, cough α< a small amount of mucus or m>®ucopurulent sputum
Sometimes patients with bloody sputum and ‌±←★other symptoms undergo laboratory diagnosis of M&☆'±ycoplasma pneumoniae
It is used to distinguish the respiratory tr™​act infections of viral o≤↔≈r bacterial, mycoplasma, ×✔β chlamydia, and provides a plan ✘↔©πfor clinical medicatiλ↑ §on
Product information
Test specimen: throat swab
Technical principle: PCR-fluorescent probe method
Packing specification: 25 tests/ kit
Category: In vitro diagnostic reagents
Applicable instruments≥∏: fluorescence quantitative P≠ ¶<CR instrument