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WELLS BIO MDx Portfolio Brochure_Eng

WELLS BIO MDx Portfolio Brochure_Eng
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WELLS BIO MDx Portfolio Brochure_Eng

Product catalog summary
Overview
Molecular diagnostic testing, particularly using polymerase chain reaction (PCR), is essential for the early detection of infectious diseases, inherited conditions, and molecular oncology. WELLS BIO, Inc., located in Seoul, South Korea, specializes in in vitro diagnostics (IVDs) and medical devices, focusing on molecular diagnostics, immunoassays, and biosensors.
Company Information
WELLS BIO, Inc. operates from its Magok R&D Center and GMP Production Facility in Seoul. The company holds ISO 13485 and GMP certifications, emphasizing early disease diagnosis and treatment.
Core Technologies
  • SBS Technology (MDx)
  • Cellulose Nanobead based Immunochromatography (RDT)
  • Strip Enzyme Activity Method (Sensor)
MDx Portfolio
WELLS BIO's molecular technologies enhance diagnostic accuracy by analyzing DNA/RNA. Their multiplexing technology allows multiple analyses in a single test, improving efficiency and cost-effectiveness.
Product Highlights
  • Q1 Amplifier: Features advanced thermoelectric refrigeration, optical design, and modular configuration for fast, accurate, and stable fluorescence quantitative analysis.
  • STD-12 Detection Kit: Utilizes real-time PCR for detecting sexually transmitted diseases, ensuring no cross-reactivity and preventing contamination.
  • HPV Screening Kit-H: Detects high-risk HPV genotypes, crucial for assessing cervical cancer risk, with a short turnaround time.
  • HPV Detection Kit-M: Detects 25 HPV types, including high-risk and low-risk genotypes, using TaqMan probe qPCR technology.
Technical Specifications
  • Q1 Amplifier features top imaging photoelectric detection, adaptable software, and a 6-partition thermal cycling module.
  • STD-12 Detection Kit targets multiple pathogens with a reaction time of less than 110 minutes.
  • HPV kits utilize real-time PCR systems for accurate genotyping and screening.
Additional Diagnostic Kits
  • Pneumonia Detection Kit: Targets 12 pathogens using a three-tube multiplex real-time PCR reaction, with high efficiency and a low limit of detection (LoD) of ≥ 25 copies/uL.
  • COVID-19 RT-PCR Kits: Detect SARS-CoV-2 genes (N gene and RdRP gene) with a one-step process and a reaction time of 83 minutes.
  • Zika Virus RT-PCR Kit: Detects Zika virus RNA in serum and urine, offering dual target detection and reduced contamination risk.
  • SFTS Virus RT-PCR Kit: Detects the SFTS virus RNA S segment in human blood using TaqMan probe technology.
  • Scrub Typhus Real-time PCR Kit: Detects Orientia tsutsugamushi gene in human blood, offering high sensitivity and specificity.
careSTART™ P1 System
An automated nucleic acid extraction system using magnetic separation technology, designed for high-throughput and efficient extraction of RNA and DNA from various specimens.
Nucleic Acid Isolation Kits
  • HiFi Nucleic Acid Isolation Kit: Used with the P1 system for automated extraction and purification of nucleic acids from human specimens.
  • Viral/Pathogen HiFi Nucleic Acid Isolation Kit: Utilizes magnetic separation technology for nucleic acid extraction from various specimen types.
Specifications
Operating temperature: 30°C, Shelf-life: 12 months, Approved by KMFDS, USA FDA listed.
Product Comparison
Comparison between the KingFisher Flex system by Thermo Fisher Scientific and a competitor, referred to as Competitor T, including performance metrics such as average and standard deviation for positive and negative controls across different channels (FAM, ROX, Cy5).
Order Information
Details on various products related to disease detection and nucleic acid extraction, including Real-Time PCR systems and kits for STD, HPV, Pneumonia, COVID-19, Zika, SFTS, and Scrub Typhus, as well as Nucleic Acid Extraction systems and kits.
Contact Information
Address: 16, Magokjungang 8-ro 1-gil, Gangseo-gu, Seoul, 07795, Republic of Korea, Email: [email protected], Tel: +82 2-3660-6900, Website: www.wellsbio.net
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Catalog excerpts

WELLS BIO MDx Portfolio Brochure_Eng-1

Portfolio Molecular diagnostic testing detects specific sequences in DNA or RNA through sensitive and specific clinical laboratory techniques, namely polymerase chain reaction (PCR). It enables not only early detection of major infectious diseases, inherited conditions, and molecular oncology, but also allows to have a greater impact on the treatment and care of patients.

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WELLS BIO MDx Portfolio Brochure_Eng-2

Magok R&D Center & GMP Production Facility - Venture company certification, company affiliated research institute establishment WELLS BIO, Inc. is researching, developing, and producing products based on immunodiagnosis, biosensor, and molecular diagnosis technology based on in vitro diagnosis technology that diagnoses diseases at an early stage. In this era when the importance of early diagnosis and treatment is on the rise due to the aging of mankind and globalization of diseases, Wells Bio will be with mankind as the world's best in vitro diagnostic company.

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WELLS BIO MDx Portfolio Brochure_Eng-3

WELLS BIO has molecular technologies to diagnose infection and genetic disorders utilizing genetic information such as DNA and RNA. These technologies enable us to examine DNA/RNA of target molecules allowing us to obtain more accurate results diagnosis compared to conventional immunological or biochemical diagnostic products. Our molecular diagnostic technologies significantly contribute to obtaining accurate diagnosis of diseases. Additionally, molecular genotyping analysis makes it possible to achieve custom diagnosis that is specific to individual patients. Our multiplexing molecular diagnostic...

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WELLS BIO MDx Portfolio Brochure_Eng-4

Q1 Amplifier careSTART™ Q1 Amplifier is based on the excellent quality of the LineGene family, using the very mature thermoelectric refrigeration technology, a new light source and optical circuit design. The unique constant current power supply and 6-zone independent temperature control method ensure that the product is fast, accurate and stable in fluorescence quantitative analysis. The product adopts modular design, with a variety of configuration options, at the same time, the addition of temperature gradient, sample 4°C cryopreservation, automatic dehumidification and other functions, fully...

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WELLS BIO MDx Portfolio Brochure_Eng-5

Test summary : The test data of 96 samples shown in the figure above were analyzed according to the baseline threshold method: avgCt=24.40667, std=0.049133, and CV=0.2%, indicating that careSTART™ Q1 Amplifier real-time fluorescence quantitative PCR analyzer had very good repeatability in fluorescence detection wells. Case 2 : Absolute quantification - Fluorescence detection sensitivity test Test summary : Summary: as shown in the figure above, it can be seen from the 1.5 times concentration of HBV fluorescence quantitative detection kit that the measured mean Ct value of 1.5 times concentration...

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WELLS BIO MDx Portfolio Brochure_Eng-6

STD-12 detection kit 70 to 80% of Sexually transmitted diseases (STD) are asymptomatic 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 STD tests with conventional end point PCR are used but have the complexity of the test and risk of cross-contamination concerns. Therefore, we adopted real-time PCR method, with has already been validated by several products, improves the accuracy and usability of the test. (5^ Features marked | KMFDSapproved...

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WELLS BIO MDx Portfolio Brochure_Eng-7

HPV is an etiologic agent for one of the most common sexually transmitted diseases. More than 100 viral types of HPV have been identified. Over 30 types of the HPV are associated with sexually transmitted infections and certain high-risk HPV can cause cancers of the cervix, vagina, vulva, penis and anus. Because 40% of HPV infections are mixed infection, the accurate identification of high-risk HPV genotypes, especially HPV 16 or HPV 18 in mixed infection, is important for assessing the risk of progression to a cervical cancer. • Demonstrates no cross-reactivity, ensuring that positive results...

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WELLS BIO MDx Portfolio Brochure_Eng-8

marked | KMFDS approved The careGENE™ HPV detection kit-M is designed to detect 25 types of human papillomavirus types (HPV). In conjunction with qPCR, it can genotype 4 high-risk HPVs (16,18,31, and 59) and 3 low-risk HPVs (6,53, and 61). It can collectively detect 10 other high-risk HPVs (HPV 33,35,39,45, 51,52,56,58,66, and 68), and 8 other low-risk HPVs (HPV 11,40,43,44,54,70, 73, and 81) from crude cervical scraping (Liquid based Cytology). This kit was developed based on TaqMan probe qPCR technology, utilizing polymerase chain reaction (PCR) for the amplification of specific target sequences...

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WELLS BIO MDx Portfolio Brochure_Eng-9

careBENy™ pneUm0nj3 (jeteCtiOD kit Pneumonia has a mortality rate of 12 to 14% despite antibiotic treatment and is one of the most common causes of death among infectious disease. In particular, the elderly has a higher mortality rate, and the prevalence of pneumonia and the resulting mortality rate are on the rise due to the rapid increase in the elderly population. It can help treat macrolide antimicrobial resistance by detecting the exact causative bacteria of pneumonia in respiratory samples of people with respiratory infections and revealing genetic mutations in mycoplasma pneumonia. • Highly...

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WELLS BIO MDx Portfolio Brochure_Eng-10

COVID-19 RT-PCR kit careGENE™ COVID-19 RT-PCR kit is developed to use the real-time RT-PCR method using Taqman probe. RNA extracted from patient specimen is converted into the complementary DNA (cDNA) by reverse-transcription and target genes are amplified by polymerase chain reaction using primers specific to two site at viral genome in order to detect N gene and RdRP gene simultaneously. In this process, the fluorescence signal decomposed from the fluorescence probe is detected by real-time RT-PCR. • One Step Real-Time Reverse Transcription PCR Technology • Preventing contamination using the...

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WELLS BIO MDx Portfolio Brochure_Eng-11

N-CoV RT-PCR kit careGENE™ N-CoV RT-PCR kit is an in vitro diagnostic medical device for qualitative detection of coronavirus disease (COVID-19) from RNA extracted from human Nasopharyngeal swab, Oropharyngeal swab and sputum using real-time RT-PCR (Reverse transcription-Polymerase Chain Reaction). • One Step Real-Time Reverse Transcription PCR Technology • Preventing contamination using the UDG (Uracil-DNA Glycosylase System) • Endogenous control included for sample extraction and amplification efficiency verification • Reaction time within 83 min (Improving laboratory efficiency) (E gene) •...

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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.