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Mycoplasma Genitalium Nucleic Acid Detection Kit(Enzymatic Probe Isothermal Amplification)

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Mycoplasma Genitalium Nucleic Acid Detection Kit(Enzymatic Probe Isothermal Amplification)

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Introduction

[Product Name]

Mycoplasma Genitalium Nucleic Acid Detection Kit(Enzymatic Probe Isothermal Amplification)

[Packaging Size]

50 tests/kit

[Intended Use]

This kit is intended for in vitro qualitative detection of Mycoplasma genitalium(Mg) DNA in male urethral secretions and female vaginal swab samples.
Mg is an extremely difficult-to-cultivate, slow-growing sexually transmitted disease pathogen, and is the smallest type of mycoplasma [1]. Its genome length is only 580bp. Mycoplasma genitalium is a sexually transmitted infection pathogen that causes reproductive tract infections such as non-gonococcal urethritis and epididymitis in men, cervicitis and pelvic inflammatory disease in women, and is associated with spontaneous abortion and preterm birth [2].

The test results are not the only basis for the diagnosis of Mg infection in patients. It is necessary to diagnose the Mg infection or colonization based on the clinical symptoms and other laboratory test and formulate a reasonable treatment plan to make the treatment safe and effective.

[Test Principle]

The kit was to detect nucleic acid of Mg using Enzymatic Probe Isothermal Amplification (EPIA). Primers and Probe with RNA bases (rProbe) were developed tailored to the highly conservative sequences in genomes of Mg and added Bst enzyme and RNaseH. Two ends of RNA bases in rProbe were labeled with fluorophores as reporter and quencher. During amplification, the target sequence was amplified in isothermal condition using DNA polymerase and strand replacement of Bst enzyme, RNaseH cleaves RNA bases on target gene-probe hybrid strands, enabling to separate the reporter dye from the quencher dye and to generate the fluorescent signal. The remaining segment of rProbe RNA can continue the amplification process to generate fluorescent signals further. The fluorescent signals can be monitored by detection system, thereby realizing the detection of the target nucleic acid. Recombinant pseudo-virus of Pine chloroplast gene was developed as internal control in the kit to monitor the quality in laboratory processing including validity of reagent and laboratory operation to avoid false negative.

[Storage Condition and Shelf-life]

This kit should be stored below -18°C and protected from light. The shelf-life is 9 months. Repeated freezing and thawing cannot exceed 4 cycles. It can be transported stably for 5 days below -18°C and protected from light.
See the packaging label for the production date, production batch number and expiry date.

[Applicable Instruments]

Applied Biosystems 7500 Real-Time PCR Systems, SLAN ® -96P Real-Time PCR Systems, LightCycler® 480 Real-Time PCR system, Easy Amp Real-time Fluorescence Isothermal Detection System(HWTS1600)

[Requirements for Samples]

1. Sample Collection
Use a medical cotton swab to insert about 1-2cm into the male urethra or female cervical orifice, rotate for 1 round, and take it out after staying for 10 seconds. Put the swab head into 1ml of normal saline and stick it to the tube wall and squeeze, the sample is obtained.
2. Storage
The samples should be stored at 2-8°C for no more than 7 days, below -18°C for no more than 4 months, and below -70°C for 12 months. Repeated freezing and thawing of samples should be avoided.
3. Transportation
It is not more than 5 days for sealed transportation in foam box with dry ice, and not more than 3 days for low temperature transportation with ice packs.

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