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SD BIOSENSOR PRODUCT CATALOG

SD BIOSENSOR PRODUCT CATALOG
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SD BIOSENSOR PRODUCT CATALOG

Product catalog summary
Overview: The document provides comprehensive information on diagnostic tests and systems under the STANDARD M10 and STANDARD F series, designed for detecting various pathogens and antibodies in human samples. These tests are intended for professional use, offering rapid results with minimal preparation.
STANDARD M10 System:
  • SARS-CoV-2 Detection: Uses nasopharyngeal swabs to detect SARS-CoV-2 nucleic acids, targeting ORF1ab and N genes, with results in 30 minutes.
  • MDR-TB Detection: Identifies Mycobacterium tuberculosis and drug resistance in sputum samples, providing results in 80 minutes.
  • HPV Detection: Detects high-risk HPV types in cervical swabs with results in 64 minutes.
  • C. difficile Detection: Identifies toxin B gene in stool samples with results in 47 minutes.
  • Arbovirus Panel: Detects multiple arboviruses in serum or plasma samples with results in 60 minutes.
  • MPX/OPX Detection: Differentiates MPX and OPX in various sample types with results in 60 minutes.
STANDARD F System:
  • Fluorescent Immunoassay (FIA): Provides qualitative and quantitative diagnostic results with high sensitivity and specificity.
  • SARS-CoV-2 Variant nAb FIA: Measures neutralizing antibodies against the Omicron variant in serum and plasma.
  • COVID-19 Ag FIA: Detects SARS-CoV-2 antigens in nasopharyngeal swabs with high sensitivity and specificity.
  • COVID-19 IgM/IgG Combo FIA: Detects antibodies to SARS-CoV-2 in serum, plasma, and whole blood.
  • Covi-FERON FIA: Detects immune responses to SARS-CoV-2 proteins in whole blood.
Technical Specifications:
  • STANDARD F2400 Analyzer: Performs 70 tests per hour with a 10.1” color touch screen and built-in printer.
  • STANDARD d-BLOCK Incubator: Maintains constant temperature for tests, ranging from 35-40°C.
Key Advantages:
  • All-in-one cartridge system for nucleic acid extraction and amplification.
  • Fast results with minimal hands-on preparation time.
  • Room temperature storage for most tests.
Respiratory Disease Tests:
  • COVID/Flu Ag Combo FIA: Detects COVID-19 and influenza antigens using nasal or nasopharyngeal specimens, with results in 10 minutes.
  • Influenza A/B FIA: Identifies influenza A and B antigens with high sensitivity and specificity.
  • RSV Ag FIA: Detects RSV antigens with high sensitivity and specificity.
  • Legionella Ag FIA: Detects Legionella pneumophila antigens in urine with high sensitivity and specificity.
  • S. pneumoniae Ag FIA: Identifies S. pneumoniae antigens in urine or CSF with high sensitivity and specificity.
Vector-Borne Disease Tests:
  • Dengue NS1 Ag FIA: Detects Dengue virus NS1 antigen with high sensitivity and specificity.
  • Zika IgM FIA: Identifies Zika virus-specific IgM antibodies with high accuracy.
  • Chikungunya IgM/IgG FIA: Detects Chikungunya virus-specific antibodies with high sensitivity and specificity.
  • Lyme IgM/IgG FIA: Identifies Lyme disease antibodies with high sensitivity and specificity.
Gastrointestinal Disease Tests:
  • Norovirus Ag Plus FIA: Detects norovirus antigens in fecal specimens with high sensitivity and specificity.
  • H. pylori Ag FIA: Identifies H. pylori antigens with high sensitivity and specificity.
  • C. difficile Toxin A/B FIA: Detects C. difficile toxins with high sensitivity and specificity.
Hepatitis Tests:
  • Anti-HBs FIA: Detects antibodies against Hepatitis B surface antigen with high sensitivity and specificity.
  • HCV Ab FIA: Identifies Hepatitis C virus antibodies with high sensitivity and specificity.
  • HAV IgM FIA: Detects Hepatitis A virus IgM antibodies with high sensitivity and specificity.
General Specifications:
  • All tests are for professional use only and require specific specimen types such as whole blood, serum, plasma, nasal swabs, or feces.
  • Testing times range from 5 to 20 minutes, with early detection options available for some tests.
  • Storage conditions for all tests are between 2 to 30 °C (36 to 86 °F).
Specifications and Procedures:
  • STANDARD F HbA1c: Measures glycated hemoglobin in blood to monitor glycemic control in diabetes.
  • STANDARD F HIV Ag/Ab FIA: Detects HIV antibodies and p24 antigens in blood, serum, and plasma.
  • STANDARD F Syphilis Ab FIA: Detects Treponema pallidum antibodies in blood, serum, and plasma.
  • STANDARD F U-Albumin FIA: Measures microalbumin in urine to predict diabetic nephropathy and cardiovascular diseases.
Performance and Method Comparison:
  • Tests show high correlation with reference methods such as HPLC and ECLIA, indicating high accuracy and reliability.
  • Sensitivity and specificity are generally high, with many tests achieving 99-100% in internal evaluations.
Storage and Handling:
  • All tests are designed for professional use only and require storage conditions between 2-30°C (36-86°F).
Ordering Information:
  • Each test kit comes with a specific catalog number and includes controls for quality assurance.
Additional Tests:
  • STANDARD F PCT FIA: Measures procalcitonin for bacterial infection severity and sepsis diagnosis.
  • STANDARD F TnI Pro FIA: Measures cardiac Troponin I for acute myocardial infarction screening.
  • STANDARD F CRP and hs-CRP: Measure C-reactive protein levels for infection and cardiovascular risk assessment.
  • STANDARD F Vitamin D FIA: Measures total 25-hydroxy Vitamin D in serum and plasma.
  • STANDARD F β-hCG FIA: Measures β-hCG for pregnancy diagnosis.
  • STANDARD F NT-proBNP FIA: Measures NT-proBNP for heart failure diagnosis.
  • STANDARD F LH and TSH-II FIA: Measure hormone levels for fertility and thyroid function evaluation.
Thyroid Function Tests:
  • TSH FIA: Used for monitoring hypothyroidism and hyperthyroidism.
  • fT4 and T3 Tests: Quantitative measurement of free thyroxin (fT4) and T3 levels in serum.
  • T4 Test: Measures thyroxin levels.
Prostate Cancer Screening:
  • PSA FIA: Measures Prostate Specific Antigen levels in serum, plasma, and whole blood.
Bowel Cancer Screening:
  • iFOB FIA: Measures hemoglobin in fecal samples for early detection of bowel cancer.
COVID-19 and Respiratory Disease Tests:
  • COVID-19 Ag Tests: Various tests for detecting SARS-CoV-2 antigens using nasopharyngeal and nasal swabs.
  • COVID/Flu Ag Combo Test: Detects antigens for both SARS-CoV-2 and Influenza A/B.
Other Disease Tests:
  • Influenza A/B Test: Detects influenza antigens.
  • Strep A Ag Test: Detects Group A streptococcal antigens using throat swabs.
  • RSV Ag Test: Detects Respiratory Syncytial Virus antigens using nasopharyngeal swabs.
  • Adeno Respi Ag Test: Detects adenovirus antigens in respiratory specimens.
  • TB MPT64 Ag Test: Detects Mycobacterium tuberculosis antigen.
  • Dengue Duo Test: Detects Dengue NS1 antigen and antibodies.
Conclusion: The document provides comprehensive details on various diagnostic tests, including their intended use, specimen requirements, testing times, and performance metrics. These tests are designed for professional use and offer reliable results for disease diagnosis and monitoring.
Diagnostic Kits:
  • Chikungunya IgM and IgG ELISA Kits: Designed for the detection of specific IgM and IgG antibodies to the Chikungunya virus in serum or plasma.
  • Dengue NS1 Ag, IgM, and IgG ELISA Kits: Used for detecting Dengue virus antigens and antibodies.
  • Zika IgM ELISA Kit: For detecting specific IgM antibodies to the Zika virus.
  • Malaria Ag ELISA Kit: Detects Plasmodium species antigens in whole blood.
  • TB-Feron ELISA Kit: Used for detecting human IFN-γ antibodies in plasma.
  • Covi-FERON ELISA Kit: Detects immune responses to SARS-CoV-2 proteins in heparinized whole blood.
Chronic Care Systems:
  • Blood Glucose Monitoring Systems: Various models like GlucoNavii PRO, GlucoNavii Elite, and CodeFree Plus are available.
  • MultiCare Analyzer: A versatile device for measuring HbA1c, CRP, U-Albumin, and lipid profiles.
  • LipidoCare Analyzer: Measures lipid profiles and glucose levels.
  • G6PD Analyzer: Quantitative analyzer for G6PD enzyme activity.
Key Features:
  • All products are intended for professional use only.
  • Most kits and systems have a shelf life of 15 to 18 months.
  • Storage conditions generally require temperatures between 2-8°C.
  • High sensitivity and specificity are reported for the diagnostic kits.
  • Chronic care systems offer features like Bluetooth connectivity, small sample volume requirements, and compliance with international standards.
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Catalog excerpts

SD BIOSENSOR PRODUCT CATALOG-1

SD BIOSENSOR PRODUCT CATALOG POC in-vitro Total Platform Company Global leader and a Korean pioneer to provide full-line solution from initial screening to confirmatory tests,

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SD BIOSENSOR PRODUCT CATALOG-2

Products Beginning of all things that protect lives SD Biosensor, Inc., with its slogan ‘Beginning of all things that protect CATALOG lives,’ global in-vitro diagnostics 2022 is a everyone’s quality of life bycompany that contributes to improving diagnosing diseases quickly and accurately. SD Biosensor is a Total Solution Provider in the IVD industry that develops and researches innovative diagnostic platforms. Continuous technological innovations for a global biotech company Based on R&D know-how, Mass Production Capacity, and Global Sales Network, SD Biosensor, Inc. will continue to grow as...

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SD BIOSENSOR PRODUCT CATALOG-3

Screening Test Confirmatory Test 01 Self test, qualitative test that can be tested by patient like a COVID-19 home test kit (for screening purpose) ■ BGMS ■ STANDARD Q Tests that can be examined by a medical staff Qualitative/Quantitative test ■ BGMS ■ STANDARD Q Test to diagnose the presence or absence of disease through medical staff ■ BGMS ■ STANDARD Q ■ STANDARD F ■ STANDARD M

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SD BIOSENSOR PRODUCT CATALOG-4

SD BIOSENSOR HISTORY OF INNOVATION Since 2010, SD BIOSENSOR has grown and evolved to make the world healthier through our innovative IVD products. Our goal is to be the global leading in-vitro diagnostics company. From starting with BGMS products, we have expanded our business to STANDARD Q(RDT), STANDARD F(FIA), STANDARD E(ELISA) and STANDARD M(POC Molecular Diagnostic Platform). We are never complacent where we are but strive to become the No.1 global in-vitro diagnostics company through continuous technological innovations. • Established SD BIOSENSOR, Inc. • Obtained FDA Approval for SD CodeFree...

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SD BIOSENSOR PRODUCT CATALOG-5

Direct sales in 7 countries Office Global Sales Networks SD BIOSENSOR has grown and evolved in chronic care and in-vitro diagnostics(IVD) industries over the last few years. Our IVD portfolio has expanded from immuno-based IVD to POC Molecular Diagnostics through the continuous technological innovations. As our product line has expanded in accordance with the global needs for IVD, our customers have increased world-wide. We are based in South Korea and have 7 global offices in India, Indonesia, China, U.S., Brazil, Germany and Italy. We also have more than 800 distribution partners in more than...

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SD BIOSENSOR PRODUCT CATALOG-6

01 STANDARD M Molecular diagnostics STANDARD F Fluorescent immunoassay 03 STANDARD Q Rapid diagnostic test 04 STANDARD E Enzyme-Linked Immunosorbent Assay Assay Menu Respiratory Infections 14 qPCR Reagent Respiratory Infections 19 Vector Borne Disease 36 Blood Borne Disease 44 Vector Borne Disease 67 Blood Borne Disease 72 Vector Borne Disease 80 05 Chronic Care Blood Glucose Monitoring System & Chronic Care Analyzers Chronic Care - Introduction 86 Chronic Care - Technology 87

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SD BIOSENSOR PRODUCT CATALOG-7

STANDARD M Molecular Diagnostics STANDARD™ M is a molecular diagnostic brand including STANDARD M10, a point-of-care molecular diagnostic system, PCR reagents and other related products. STANDARD™ M10 is a versatile POC system designed for more accurate, simpler and faster clinical decision making near-the-patient using real-time PCR or real-time LAMP. STANDARD™ M10 is an automated system that integrates extraction and amplification of nucleic acids from various specimens and detection of target sequences. STANDARD™ M10 consists of STANDARD™ M10 Module and STANDARD™ M10 Console. The entire testing...

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SD BIOSENSOR PRODUCT CATALOG-8

STANDARD M10 Versatile Point-of-Care Molecular Diagnostic Platform POC Molecular Diagnostic Platform designed for more accurate, simpler and faster clinical decision making near-the-patient. Versatile Point-of-Care Molecular Diagnostic Platform FEATURES • User friendly GUI with animated guide • Seamless connectivity with HIS/LIS • Memory up to 5,000 with Ct values & amplification curves • 10.1" touch screen • Customized configuration up to 8 modules • Alternative operating system to PC (Window) • Minimized maintenance requirements • Intuitive status indicator • Small footprint Gastrointestinal...

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SD BIOSENSOR PRODUCT CATALOG-9

D s Multiplex real-time RT-PCR test intended for use with STANDARD™ M10 system for the s qualitative detection of nucleic acid from the SARS-CoV-2 ORF1ab(RdRp) gene and E gene in upper respiratory specimens(such as nasopharyngeal) collected from individuals suspected of COVID-19. Test type Professional Use Only c Specimen type Nasopharyngeal swab Reference Clinical Sensitivity Clinical Specificity Limit of Detection (LoD) STANDARD™ M10 Flu/RSV/SARS-CoV-2 is a multiplex real-time RT-PCR test intended for use with STANDARD M10 system for the qualitative detection of Influenza A, Influenza B, RSV...

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SD BIOSENSOR PRODUCT CATALOG-10

STANDARD™ M10 MDR-TB is a multiplex real-time PCR test intended for use with STANDARD M10 system for the qualitative detection of Mycobacterium tuberculosis nucleic acids and drug-resistance against rifampicin(RIF) and isoniazid (INH) in human normal sputum or sputum sediment sample. Test type Specimen type Storage condition Advantage Professional Use Only Pretreated normal sputum, sputum sediment sample 2 ~ 28°C - All-in-one cartridge (NA extraction + amplification) - Simultaneous detection of M. tuberculosis and drug-resistance against rifampicin (RIF) and isoniazid (INH) - Fast result in 80...

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SD BIOSENSOR PRODUCT CATALOG-11

STANDARD™ M10 Arbovirus Panel is a multiplex real-time RT-PCR test intended for use with STANDARD M10 system for the qualitative detection of Arbovirus; Dengue virus(DENV), Zika virus(ZIKV), Chikungunya virus(CHIKV), Yellow Fever virus(YFV) and West Nile virus(WNV) nucleic acids in human serum or plasma sample. Test type Specimen type Storage condition Advantage Professional Use Only Serum, Plasma 2 ~ 28°C - All-in-one cartridge (NA extraction + amplification) - Simultaneous detection of DENV, ZIKV, ChIKV, YFV and WNV - Fast result in 60 minutes - Serum / plasma sample - Room temperature storage...

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