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careGENE™ STD-12 detection kit Brochure

careGENE™ STD-12 detection kit Brochure

careGENE™ STD-12 detection kit Brochure

Product catalog summary
Introduction
The document discusses the prevalence and risks of sexually transmitted diseases (STDs), noting that 70-80% of cases are asymptomatic. Untreated STDs can lead to severe health issues in women, such as vaginitis, cervical cancer, and urethritis, potentially causing complications like abortion, premature birth, and infertility.

Testing Methodology
The document highlights the limitations of conventional endpoint PCR tests, including complexity and cross-contamination risks. It introduces the real-time PCR method, which enhances test accuracy and usability. The STD-12 detection kit is designed to improve comprehensive screening and blood tests for various STDs.

Features of the STD-12 Detection Kit
  • Internal control to prevent false negatives by flagging invalid negative results.
  • Uracil-DNA Glycosylase (UDG) system to prevent contamination.
  • No cross-reactivity within STD-12, ensuring clinically meaningful positive results.
  • Short turnaround time of less than 2 hours.

Technology
The kit uses TaqMan probe qPCR technology for amplification and detection of specific target sequences.

Clinical Performance
The document provides detailed clinical sensitivity and specificity data for various pathogens, including Neisseria gonorrhea, Chlamydia trachomatis, and others. The performance is evaluated using urine and swab specimens, showing high sensitivity and specificity rates.

Kit Configuration and Usage
  • Instrumentation: CFX 96 real-time PCR detection.
  • Kit Configuration: 100 tests per kit.
  • Technology: Multiplex real-time PCR.
  • Sample Type: Vaginal swab, Urine.
  • Input Volume: 5 μL.
  • Internal Control: Endogenous human sequence for validation.
  • External Control: Negative and positive controls.

Ordering Information
The careGENETM STD-12 detection kit is available for the CFX96 real-time PCR Detection system, with a unit size of 100 tests per kit. The document provides contact information for technical support and ordering details.
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Catalog excerpts

careGENE™ STD-12 detection kit Brochure-1

STD-12 detection kit Transforming testing & treatment together 70 to 80% of Sexually transmitted diseases (STD) are a symptomatic even though they are infected. If not treated properly, women may cause vaginitis, cervical cancer, and urethritis, which can cause serious complications such as abortion, premature birth, and infertility. The current comprehensive screening and blood tests have limitations for pathogenesis of various STD. The STD tests wiht conventional end point PCR are used but have the complexity of the test and risk of crosscontamination concerns. Therefore, we adopted real-time PCR method, with has already been validated by several products, improves the accuracy and usability of the test.

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careGENE™ STD-12 detection kit Brochure-2

• Internal control : endogenous internal control helps prevent false negatives. STD negative specimens with negative result are flagged as invalid, helping prevent reporting false negative results. • Uracil-DNA Glycosylase(UDG) system is adapted to prevent contamination • Demonstrates no cross-reactivity within STD-12, ensuring that positive results are clinically meaningful. • Short turn around time, less than 2 hours reaction time. TaqMan probe qPCR technology for amplification of specific target sequences and target probe for the detection and detemination of the amplicons.

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careGENE™ STD-12 detection kit Brochure-3

The test was evaluated by the domestic clinical laboratory using liquid cell specimens with 4,218 positive (1,940 swab specimens, 2,278 urine specimens) and 19,470 (9,016 swab, 10,454 urine) negative specimens were tested.

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careGENE™ STD-12 detection kit Brochure-4

careGENE™ STD-12 detection kit for CFX96 real-time PCR Detection system / Korea-IVD; CE-IVD *Please contact technical support in case you want to apply it to other equipment. - Component: 2X Reaction Mixture Aset Primer/Probe mix B set Primer/Probe mix C set Primer/Probe mix Positive Control A, Positive Control B, Positive Control C Nuclease free water, Instructions for Use e-mail: [email protected] WELLS BIO, INC. WWW.WellsbiO.net Tel: + 82 2-3660-6900 Seoul, 07795, Republic of Korea

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.
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