P109H - Mycoplasma Pneumoniae Nucleic Acid Detection Kit

• Type: IVD Reagent
• Spec: 32T
• Transport Package: Paper Carton with Icy Bag
• Specification: 44*44*45 cm
• Trademark: Tianlong
• Origin: Suzhou
• Model NO.: P109H
• HS Code: 3822009000
• Production Capacity: 5000000 Test/Year

Product Description

Product Name:
Mycoplasma Pneumoniae (MP) Nucleic Acid Detection Kit (Fluorescence PCR method)

Spec:
32T/kit

Intended Use:
The kit is used for qualitative detection of Mycoplasma pneumoniae nucleic acid in human sputum and throat swab samples.

Mycoplasma pneumoniae usually causes mild upper respiratory tract infections, such as sore throat, laryngitis, tracheitis and accounts for 50% of non-bacterial pneumonia. It is a kind of microorganism between bacteria and virus, with no cell wall structure, which is facultative anaerobic and can live independently. The laboratory tests of Mycoplasma pneumoniae include: 1) Isolation and culture of Mycoplasma pneumoniae; 2) Serological methods; 3) Nucleic acid amplification test. The kit developed by our company is suitable for the auxiliary diagnosis of mycoplasma pneumoniae. The test results of this kit are for clinical reference only and cannot be used as the basis for diagnosis or exclusion of cases.

Principle of Test:
The highly conserved sequences of Mycoplasma pneumoniae was selected to design specific primers and Taqman probes. The probes can specifically bind to a DNA template in the middle of the primer amplification region. In the process of PCR extension, the exonuclease activity of Taq enzyme will cut off the 5'end fluorescent groups from the probes, freeing them in the reaction system, thus breaking away from the shielding of the 3'end fluorescence quenching groups, which can receive light stimulation and emit fluorescence that can be detected by the instrument, so as to achieve the automatic detection of mycoplasma pneumoniae nucleic acid in closed reaction system.

A synthetic non-competitive sequence was designed as an internal control template of this kit, which has no interference with the target gene of Mycoplasma pneumoniae, then BLAST ratio analysis was performed for this sequence on NCBI website, confirmed that it cannot be found in the NCBI nucleic acid library, no interfere with each other. The primers and probes were designed according to the internal control template, the internal control adopts VIC channel, so as to realize the detection process monitoring in closed reaction system, which can effectively monitor the occurrence of false negatives.

Kit Contents:

Composition	Major Component	Specification
Nucleic acid extract solution	Tris, EDTA, NaCl, NaOH, NP-40, Triton-100, Chelex-100, Internal control template	1.8mL×1
MP reaction mixture	Tris-HCl, KCl, MgCl2, dTTP, dATP, dGTP, dCTP, primer and probe	1.2mL×1
Taq enzyme	Taq DNA enzyme and antibodies	28μL×1
MP positive control	MP genomic DNA(Recombinant clone)	100μL×1
Negative control	main components are NaCl	100μL×1

Storage Condition & Validity:
All reagents could be stored at -20ºC±5ºC for 12 months.

The unused reagents can be sequentially cryopreservation without affecting their stability. The regents could be preserved for 30 days at -20ºC±5ºC after repeated thawing and freezing three times. The opened reagents should be placed at room temperature under the condition of no more than 8 hours. The products should be transport by ice box or refrigerated truck. Simulated transport tests indicate that the stability and validity could not be influenced by transport, but the transportation time should not exceed 7 days.

Applicable Instrument:
Tianlong Gentier96E and Gentier96R PCR Analysis System , ABI 7500 Real-Time PCR System ,

Sample Requirements:

1. Sample: human sputum and throat swab samples.

2. Collection: for specific sampling method, please refer to the "Microbial Specimen Collection Manual".

  2.1 Sputum sample: natural sputum coughing method, morning sputum is better, forcibly cough out the deep respiratory tract
        sputum and directly spit into the sputum box, the sample size should be greater than or equal to 1mL.
  2.2 Throat swab sample: use a sterile cotton swab to pass through the root of the tongue to the posterior wall of the pharynx or
        the back of the palatal lobe, smear several times, place it in a sterile glass tube and seal it for inspection.

3. Storage: Samples can be stored at 2~8ºC for no more than 24 hours; at -20ºC±5ºC for no more than 3 months; under -70ºC for
     a long time, but repeated freeze-thaw should be avoided.
4. Transportation: transport with ice or foam containers sealed with ice.

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