careGENE™ STD-12 detection kit Brochure

Product catalog summary

Overview: The STD-12 detection kit is an in vitro diagnostic medical device designed to detect DNA from 12 pathogens responsible for sexually transmitted infections (STIs) using Real-time PCR. It is compatible with CFX 96™ Dx Systems (Bio-Rad) and utilizes TaqMan probe technology and the Uracil-DNA Glycosylase (UDG) system for high sensitivity.

Pathogens Detected: The kit targets Herpes Simplex Virus 1 and 2 (HSV1, HSV2), Chlamydia trachomatis (CT), Ureaplasma urealyticum (UU), Mycoplasma genitalium (MG), Treponema pallidum (TP), Ureaplasma parvum (UP), Mycoplasma hominis (MH), Trichomonas vaginalis (TV), Candida albicans (CA), Gardnerella vaginalis (GV), and Neisseria gonorrhea (NG).

Sample Types: The kit is designed for use with vaginal swabs and urine samples.

Performance: Clinical sensitivity and specificity were evaluated using samples from domestic clinical trial sites. The kit demonstrates high sensitivity and specificity across various pathogens and sample types.

Quality Control: Positive control materials (PC A, PC B, PC C) and negative control (nuclease-free water) are used to ensure accuracy. Positive results are indicated by a Ct value of 40 or below, while negative results are above 40 or undetectable.

Product Specifications: The careGENE™ STD-12 detection kit is available in different sets (A, B, C) targeting specific pathogens. The product has a shelf life of 12 months when stored below -20°C.

Amplifier Specifications: The careSTART™ Q3 Amplifier features six fluorescence channels, an intelligent adjustable hot cover, and a full adaptable software system. It operates within a temperature range of 4°C to 99.5°C with high temperature control accuracy and uniformity.

Contact Information: For further inquiries, contact via Tel: +82 2-3660-6900.

Catalog excerpts

careGENE™ STD-12 detection kit Brochure-1

Detection of Pathogens Responsible for Sexually Transmitted Infections Sexually transmitted infections (STIs) are inﬂammatory and infectious diseases spread through sexual contact between individuals. These infections can be caused by various pathogens, including more than �� types of viruses, bacteria. Common STIs include gonorrhea, syphilis, and chlamydia. Even without symptoms, these infections can remain contagious, making it essential for its detection and prevention. In certain situations, transmission can also occur through blood transfusions or shared intravenous needles, alongside sexual contact. 12 Pathogens Neisseria gonorrhea (NG) Chlamydia trachomatis (CT) Herpes Simplex Virus � (HSV�) Herpes Simplex Virus � (HSV�) In vitro diagnostic medical device designed to quantitatively detect and extract the DNA of �� pathogens responsible for sexually transmitted infections from vaginal swab and urine samples using Real-time PCR. Verification of sample extraction and amplification efficiency using Endogenous internal control Diagnostic reagents with high sensitivity utilizing TaqMan probe technology Uracil-DNA Glycosylase (UDG) system applied Compatible with CFX 96™ Dx

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careGENE™ STD-12 detection kit Brochure-2

Product PerformanceThe clinical sensitivity and specificity were evaluated using clinical samples collected from domestic clinical trial sites. Target Pathogen e-mail: [email protected] 16, Magokjungang8-ro 1-gil, Gangseo-gu, Seoul, 07795, Republic of Korea

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careGENE™ STD-12 detection kit Brochure-3

rriteria " Positive: Ct value of 39 or below - Negative: Ct value above 39 or undetectable Positive Negative Amplification Quality Control The positive control materials used are PC A, PC B, and PC C, while the negative control material is nuclease-free water. 1) Positive Control (PC A, PC B, PC C): The Ct values for ROX (IC), FAM, HEX, CY5, and Quasar 705 signals must be 39 or below. 2) Negative Control (Nuclease-free water): The Ct values for ROX (IC), FAM, HEX, CY5, and Quasar 705 signals should not be detectable. e-mail: [email protected] 16, Magokjungang8-ro 1-gil, Gangseo-gu, Seoul, 07795,...

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careGENE™ STD-12 detection kit Brochure-4

S 6 Fluorescence channels S Intelligent adjustable hot cover Automatic pop-up sample bin S Full adaptable software system S Top imaging photoelectric detection Product Parameters Product name e-mail: [email protected] 16, Magokjungang 8-ro 1-gil, Gangseo-gu, Seoul, 07795, Republic of Korea

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