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Singuway Nucleic Acid Detection Kit
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STD 12 Multiplex


Intended Use



The Detection Kit for STD 12 (PCR-Fluorescence Probing) is an in vitro diagnostic test, based on real-time PCR technology, for the detection of Neisseria gonorrhoeae (NG) , Chlamydia trachomatis, HSV-2 and other twelve pathogens in urethral or genitourinary tract swab samples. To determine whether the patient is infected with these pathogens. Sexually transmitted diseases (STDs), also known as sexually transmitted infections (STIs) or venereal diseases, are contagious infections caused by pathogens (bacteria, virus, parasite) and spread from person to person via sexual activity and intimate contact.
The test results are for clinical reference only and cannot be used alone as a basis for confirming or excluding cases.



Technical Specifications

REF No.

STD012

Regulatory Status

CE IVD

Packing Specifications

24 tests/kit, 48 tests/kit

Technology

Real-time PCR

Type Of Analysis

Qualitative

Sample Type


Urethral swab, genital tract secretion swab


Reaction Volume

22μL

Detecting Target

UP/NG/ΤP/HSV-2/MG/CT/CA/GV/HSV-1/UU/MH/TV

Analytical Sensitivity

1000 copies/mL

Precision

CV≤5%

Storage

-20±5℃ in darkfor 12 months

2~8℃ after opening the cover for2 weeks

Validated Extraction Method

General nucleic acid extraction kit (Singuway Ref No.: MTQ064/MTQ096) is recommended.

Instruments


A real-time PCR instrument containing at least four colors fluorescence channels, Singu9600, Singu9600 Pro, AccuRa-32, AccuRa Mini, Bio-Rad CFX96, ABI 7500, Roche LightCycler 480.


Required Detection Channels

FAM, HEX, CY5, ROX

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