ReagenX

Sexually Transmitted Infection (STI) Screening Kit (Fluorescence PCR method)

A multiplex qPCR kit designed for comprehensive STI/STD screening, detecting 14 bacterial and viral pathogens from urogenital swab or urine specimens. Stable at room temperature, it enables accurate, rapid testing without the need for cold-chain transport. Ideal for clinical diagnostics, surveillance research, and targeted therapy support.

STI

This kit is a multiplex fluorecent probe-based Taqman® qPCR assay system. Specific primers and probes are designed for the detection of specific genes of 14 common STI/STD pathogens.
Internal control(IC) serves as the monitor to confirm successful extraction and identify possible PCR inhibition for the entire testing system to prevent false negative detection results.In order to avoid aerosol contamination of the amplified products, the UDG enzyme /dUTP system was added to the amplification system to effectively degrade the amplified products and avoid false positive results.
This kit is a fully premix freeze-dried system. Taq enzyme, UDG enzyme, reaction buffer, specific primers and probes required for amplification are all lyophilized in PCR tubes. Detection can be performed directly after adding dissolving solution and extracted nucleic acid.

Targets	Trichomonas vaginalis	Targets	Ureaplasma urealyticum
	Neisseria gonorrhoeae		Ureaplasma parvum
	Chlamydia trachomatis		Mycoplasma hominis
	Gardnerella vaginalis		Mycoplasma genitalium
	Haemophilus ducreyi		Treponema pallidum
	Candida albicans		Herpes simplex virus type 1
	Streptococcus agalactiae		Herpes simplex virus type 2

Components	8 samples/kit	24 samples/kit	Ingredient
ST01 Lyophilized Reagent	8×4 strip tubes	24×4 strip tubes	Specific primer&probes, dNTP/dUTP, Mg2+, Taq polymerase and UDG enzyme
STI Lysis Buffer	1 mL×1 tube	5 mL×1 tube	Surface active agent, balanced salt solution
One Test Glass Beads	8 tubes×1 bag	8 tubes×3 bags	Glass beads
STI Positive Control	400 μL×1 tube	400 μL×1 tube	Plasmid containing every target gene sequence
STI Negative Control	400 μL×1 tube	400 μL×1 tube	Plasmid containing internal control sequence
Dissolving Solution	1 mL×1 tube	1 mL×2 tubes	Stabilizer

Store frozen at -20±5℃.
The kit can be transported at room temperature (≤ 1 month).
Repeated freezing and thawing should not exceed 7 times.
Valid for 12 months(From the QC passed).

Disposable powder free gloves and other personal protective equipment.
Pipettes (adjustable) and Sterile pipette tips.
Vaginal swabs/urine sample collection device.
1.5 mL centrifuge tubes and racks.
Bench top centrifuge for centrifuge tubes and PCR tubes.
Vortex mixer.(Power≥40w)
Centrifuge tube holder for vortex mixer. (not necessary,can replace part of manual operation)
Metal bath/water bath.(1.5mL centrifuge tube,95℃)
Real-time PCR instrument with FAM/VIC/ROX/CY5 fluorescence channels.(Such as ABI7500, Bio-rad CFX96, QuantStudio, SLAN-96S, BTK-96, BTK-16)

Detection limitation: 1000 Copies/mL.
Precision: The coefficient of variation (CV, %) of Ct value of within-batch/between-batch precision is ≤ 5%.
Accuracy: The conformity rate of negative/positive reference: 100%.
Specificity:The target organisms had been analyzed in silico for potential cross-reactivity with the primers or probe sequences.Homology with other species is all below 90%. Specificity analysis showed that there is no cross reaction between the pathogens detected by this kit.