SPAN BIOTECH LTD.
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FOR IN VITRO DIAGNOSTIC USE ONLY INTENDED USE ONE STEP TROPONIN I TEST IS AN IMMUNOCHROMATOGRAPHY BASED ONE STEP IN VITRO TEST. IT IS DESIGNED FOR QUALITATIVE DETERMINATION OF CARDIAC TROPONIN I (CTNL) IN HUMAN WHOLE BLOOD, SERUM OR PLASMA AS AN AID IN THE DIAGNOSIS OF MYOCARDIAL INFARCTION. SUMMARY Cardiac Troponin I (cTnI) is a cardiac muscle protein with a molecular weight of 22.5 kilodaltons. Together with troponin T (TnT) and troponin C (TnC), TnI forms a troponin complex in heart to play a fundamental role in the transmission of intracellular calcium signal actin-myosin interaction. Although troponin I is also found in skeletal muscle, cardiac troponin I (cTnI) has an additional amino acid residues on its N-terminal which distinguishes it from its skeletal muscle form making cTnI a specific marker for indicating cardiac infarction. cTnI is released rapidly into blood stream soon after the onset of acute myocardial infarction (AMI). Its release pattern is similar to CK-MB (4-6 hours after the onset of AMI). However, CK-MB level returns to normal after 36-48 hours, when levels of cTnI remains elevated for up to 6-10 days. The level of cTnI is below 0.06ng/ml in average in healthy people, and also not detected in the patients with skeletal muscle injury. Therefore, cTnI is a specific marker for diagnosis of AMI patients. The level of cTnI may reach 100-1300ng/ml in some AMI patients. PRINCIPLE OF THE ASSAY The One-Step Troponin I Test is a chromatographic immunoassay for the qualitative determination of cTnI in human whole blood, serum or plasma. When specimen is added to sample pad, it moves through the conjugate pad and mobilizes gold anti-cTnI conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with anti-cTnI antibody that is coated on the test region. If cTnI is present, the result is the formation of a colored band in the test region. If there is no cTnI in the sample the area will remain colorless. The sample continues to move to the control area and forms a pink color, indicating the test is working and the result is valid. STORAGE AND STABILITY 1. Store as packaged in the sealed pouch at 2-30°C 2. The test device must remain in the sealed pouch until use. 3. DO NOT FREEZE. 4. Do not use beyond the expiration date. PRECAUTIONS 1. For professional and IN VITRO diagnostic use only. 2. The test device should remain in the sealed pouch until use. Do not use after the expiration date. 3. All serum or plasma specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. 4. The test device should be discarded in a proper biohazard container after testing. 5. Avoid cross-contamination of serum samples by changing a new specimen pipette for each sample.
SPAN BIOTECH LTD.
Unit 5, Building 3, Sunshine Aloha, Bantian Industrial Park,Shenzhen,Guangdong, China
Beauty & Personal Care,Other Health Care Products
No. of Total Employees
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service. Efficiently structured to provide lasting and economic health care solutions with export ready goods, our main products cover the following immunodiagnostic rapid test kits: Rapid Tests for Human Use : 1) Fertility: Pregnancy HCG, ovulation LH, menopause FSH 2) Infectious diseases: Hepatitis B, HCV, HIV 3) Drug abuse: AMP, BAR, BZO, COC, mAMP, MOP, MTD, OPI, PCP, TCA, THC 4) Tumor markers: CEA, PSA, AFP, FOB 5) STDs(Sexually Transmitted Diseases): Gonorrhea, syphilis, chlamydia 6) New products: Malaria, H. Pylori, Multi-Hepatis B Panel (HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc), Blood Glucose Test, Multi-drug of Abuse Panel, Avian (Bird) Flu Rapid Test, etc. Rapid Tests for Veterinary : (1) Bovine: Cow Pregnancy , Cow Ovulation, Bovine Brucella, Bovine Tuberculosis ,Food and Mouth Disease NSP Ab Test (2) Canine: Canine Distemper, Canine Parvovirus, Canine Coronavirus (3) Feline : Feline Leukemia Virus Ag Rapid Test ,Feline Panleucopenia Virus Ag Test,Feline Immunodeficiency Virus Ab Test
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