PRODUCT INFORMATION. Pre Analytical Systems

Transcription

1 TUD SDN BHD 9-1, Jalan Temenggung 9/9, Bandar Mahkota Cheras, 300 Cheras, Selangor, Malaysia Tel: Fax: PRODUCT INFORMATION Pre Analytical Systems

2 Information. Issue 1 / Jan 015 Information. Issue 1 / Jan 015

3 Contents Introductions page Training and Support page 3 Tube Information page Tube Label page 5 Glucose Tubes page 6 EDTA Tubes page 7 Introduction We believe a great company culture is the key to our success. As we ve grown over the years, we felt it was important to try and distil our core values and what we are feel are important to us as a business, the way we work and the way we think; TUD was established in Malaysia since year 008, with the local government support in all aspect of certification and distribution. It has advanced to be one of the largest blood collection tubes supplier in Malaysia and oversea since year 010. TUD has a network of professional distributors who are highly regarded in the market place and who provide added value to the TUD products and services. TUD Brand Positioning TUD are synonym as Tactful, Unique & Dynamic Coagulation Tubes page 8 ESR Tubes page 9 Plasma Tubes page 10 with Gel Tubes (Plasma Separator Tube) page 11 TACTFUL With well tactical and strategist planning before every move. UNIQUE New way of technology that provide better life. DYNAMIC Enthusiasm and passion. Serum Tubes page 1 Fast Clot Tubes page 13 Our Core Brand Values Gel & Clot Tubes page 1 Trustworthy We strive our products are Innovation In our effort to offer more, we Management Team The quality of a company s ACD Solutions Tubes page 15 K EDTA With Gel (Plasma Preparation Tube) page 16 Summary of TUD Tubes & page 17 Compliances page 18 of the highest quality and our brand trustable by our costumer with state-of-the-art technology, fully automated processes and continuous research and development embrace the innovation of our processes and products to meet the ever changing needs of customer. It is our goal to ensure satisfaction with new and improved products at affordable prices. management team is one of the best predictors of success. We always believe words doesn t symbolized everything, but with our proven track records in winning the main hospital tender and Symbols page 19 About TUD page 0 that guarantee the quality of our products are at the highest range. coverage network within the past year should be enough showing our commitment in this industry. Information. Issue 1 / Jan Information. Issue 1 / Jan 015

4 Training & Support Tubes Information Our products consist all the aspect of the international materials guideline, the quality and specification of the products made according to the international reference which been certified by international certification body. Control of quality and safety for every batch of production. Appropriate use of International Reference Materials by national control laboratories or designated laboratories and manufacturers. The responsibility of promoting the quality products. We offer users a variety of high quality training programmes to continually update healthcare workers in the use of our blood collection tubes although it is simple and easy for use, but it is important for all healthcare workers to aware for all the process and step which might cause the samples contaminated. 10.5mm x 6mm 13mm x 75mm Non Gel 1.8ml, ml,.5ml,.7ml, 3ml, 3.5ml, ml,.5ml, 5ml, 6ml With Gel - 3.5ml 13mm x mm Non Gel ml,.5ml, 5ml, 6ml, 6.5ml, 7ml With Gel - ml,.5ml, 5ml 16mm x mm Non Gel 8ml, 8.5ml, 9.5ml, 10ml With Gel - 8ml CME Continual medical education for understanding the technical faulty and steps for blood draw Tube Chart Giving guidance to all healthcare staff on tubes support Technical FAQ Guidance on all technical fault There are few types of tube material: 1.. Glass - with vacuum or non vacuum which to suit the local markets in different countries. 3. All TUD blood collection tubes incorporate the latex-free closure; inner stopper and outer protective cap, it is easy to remove and recap by the following procedures : for removal of TUD Rubber Stopper Grasp the blood tube with Move thumb away before Lift closure off tube. In the one hand, placing the thumb lifting closure. Caution: unlikely event of the plastic Mandarin and English version Technical support Well trained technical team Technical Support tech@tud.my under the closure. With the other hand, twist the closure while simultaneously pushing Do not use thumb to push closure off tube. If the tube contains blood, an exposure shield separating from the rubber stopper, do not reassemble closure. Carefully up with the thumb of the hazard exists. remove rubber stopper from other hand, only until the tube tube. stopper is loosened. Information. Issue 1 / Jan Information. Issue 1 / Jan 015

5 Tubes Label Glucose Tubes Type Color -coded TUD Fluoride/Oxalate or TUD Fluoride / EDTA tubes are used for glucose determinations. 1ml samples contain NaF/Oxal mg/mg NaF/Oxal mg/mg Single Use only NaF/EDTA mg/mg Expired Date NaF/EDTA mg/mg NaF/EDTA mg/mg 10.5*6 Blood CE Mark Lot Number Volume Flouride acts to inhibit the glycolytic pathway by blocking the enzyme enolase to prevent consumption of plasma glucose. Oxalate act similar to EDTA. Dry powdered sodium flouride/ potassium oxalate or sodium flouride/edta. Glucose testing Above shown the common label of TUD Blood Collection Tubes which often use by healthcare staff. Accuracy info in the label could improve the efficiency of works, and smoothies the daily blood drawing process. Mix thoroughly by inversion. Avoid vigorous mixing as flouride oxalate tubes are more susceptible to haemolysis. < 1300g for 10 minutes at 5 C Room Temperature Grey At TUD, we think about the healthcare staff needs, we produce different language label to prevent any error due to language misunderstand. Information. Issue 1 / Jan Information. Issue 1 / Jan 015 6

6 EDTA Tubes Coagulation Tubes TUD EDTA tubes are generally used for whole blood Haematology determination. Na citrate tubes are generally used for whole blood Haematology determination. 1ml samples contain 1ml samples contain Tube Materials EDTA K 1.85mg (0.109) (3.%) 0.mg EDTA K EDTA K EDTA K EDTA K 1.85mg 1.85mg 1.85mg 1.85mg 3 * 6* G G (0.109) (3.%) (0.109) (3.%) (0.109) (3.%) 0.3mg 0.mg 0.3mg EDTA K3.0mg (0.19) (3.8%) 0.mg EDTA K3 EDTA K3 EDTA K EDTA K3.0mg.0mg 1.85mg.0mg 10.5*6 10.5* G G (0.19) (3.8%) (0.19) (3.8%) (0.19) (3.8%) 0.3mg 0.mg 0.3mg Acts along the coagulation pathway by removing calcium from the blood. Di-potassium (K) / Tri- potassium (K3) Water Fog Based For Hematology, Blood Type, Verification, Cross Matching Test. Determinations: FBC (CBC), FBP, HbA1C, CD/ CD8, IPTH, PCR ( HIV ), Viral Load For HIV, Anticardiolipin Antibody, Antiphospholipid Antibody, F cell, Simplified Acid Elution test. Removing Calcium by forming a complex with the calcium. Disrupting the clotting mechanism. It is reversible with addition of calcium. Liquid with 3.% or 3.8%. For Blood Coagulation Test. PT/aPTT Substitution Test, Factor VIII, Factor IX, D-Dimer, Fibrinogen, Thrombophilia Profile. Mix thoroughly by inversion. Note that spray dried EDTA is least soluble of all additives. In adequate mixing may lead to platlet clumps, micro-clots. N / A Lavender Need a very gentle inversion. Plastic - 000g-500g for 10~15 minutes at 5 C Room Temperature. Glass g for 15 minutes at 5 C Room Temperature. Light Blue Information. Issue 1 / Jan Information. Issue 1 / Jan 015 8

7 ESR Tubes Plasma Tubes TUD ESR tubes are used for measuring the Erythrocyte Sedimentation Rate (ESR). TUD or Sodium tubes are used for plasma determinations in Clinical Chemistry. 1ml samples contain Tube Materials 1ml samples contain 0810XXX15G 0.19 (3.8%) 0.038g/ml 8*10 1.8/ 1.6/.0 / XXX07G (3.%) 0.03g/ml 8*10 1.8/ 1.6/.0 / XXX (3.8%) 0.038g/ml 1.8/ 1.6/ Sodium 1375XXX (3.%) 0.03g/ml 1.8/ 1.6/ Sodium 10.5*6 6 To measure the Erythrocyte Sedimentation Rate (ESR). Need a very gently inversion 8 10 times. Liquid. N / A Erythrocyte Sedimentation Rate (ESR) is measured in mm/hr using the Modified Westergren Method. Example : Age (in years)+10(if female) ESR(mm/h) Black Acts mainly by blocking thrombin reaction thus prevents conversion of fibrinogen into fibrin. < 1300g for 10 minutes at 5 C Room Temperature Determination In Plasma For Biochemical Testing. Determinations for STAT determinations in Chemistry test **[Liver Function Test (LFT), Fasting Serum Lipid (FSL), Renal Profile (Creatinine, Urea & electrolytes; Na+, K+, Cl-) Cardiac Enzymes(CK, LDH, AST), Creatine Kinase- MB, Uric Acid, Calcium, Inorganic Phosphate, Magnesium, Amylase, Gamma GT, C-reactiveProtein, Cholinesterase, Iron, UIBC, Immunoglobulins IgG, IgM, IgA, Complement C3/C, Ammonia, Lactate] HLA-typing.. Green Information. Issue 1 / Jan Information. Issue 1 / Jan

8 With Gel Tubes Serum Tubes TUD with gel tubes are used for plasma determinations in Chemistry. TUD Serum Tubes used for serum determination within clinical chemistry and serology. 1ml samples contain Clotting Period Silica (Clot Activator) L. with Gel Silica (Clot Activator) L. with Gel Silica (Clot Activator) Silica (Clot Activator) 6* L. with Gel 10.5* Silica (Clot Activator) None 10.5*6 Acts mainly by blocking thrombin reaction thus prevents conversion of fibrinogen into fibrin, during centrifuge the gel forms a barrier providing a stable barrier separating the plasma from cells. Spray dried and Gel. STAT chemistry tests, these include tests for the evaluation of endocrine and metabolic disorders, therapeutic drug monitoring and toxicology, protein electrophoresis, lipid panels, as well as those tests commonly called routine such as hepatic function tests, electrolytes and markers of cardiac damage. Clot activator will decrease the time of clotting the blood will clot faster. Dry clot activator. Determination in Serum For Biochemical, Immunology, Serology/ Virology, and other serum investigations. Mix thoroughly by inversion times. 1300g- 000g for 10 minutes at 5 C Room Temperature. Green Mix thoroughly by inversion times. Let the blood clot properly before proceed onto another step. < 1300g for 10 minutes at 5 C Room Temperature. Red Information. Issue 1 / Jan Information. Issue 1 / Jan 015 1

9 Fast Clot Tubes Gel & Clot Tubes TUD Fast Clot Tubes contains a thrombin based medical clothing agent which will faster serum sample when urgency sample is required. TUD Gel & Clot Tubes used for serum determination which contain gel for the purpose to form a barrier between serum and whole blood after centrifuge. Clotting Period Tube Materials Clotting Period Thrombin 5 minuets Gel / Silica Gel / Silica Thrombin 5 minuets Gel / Silica Thrombin 5 minuets Gel / Silica Thrombin 5 minuets Gel 10.5*6 Thrombin will accelerate the time of clotting the blood. Mix thoroughly by inversion times. Let the blood clot properly before proceed onto another step. Thrombin < 1300g for 10 minutes at 5 C Room Temperature. For STAT serum determination in chemistry. Orange Clot activator will decrease the time of clotting the blood and the gel will act as a separator between blood and serum. 1500g 000g for 10 minutes at 5 C Room Temperature. Determination in Serum For Biochemical, Immunology, Serology/Virology, and other serum investigations. Determinations for Routine determinations in Chemistry test, Serum Osmolality,, Ceruloplasmin, Immunology test; TSH, T, FT, FT3, FSH, LH, Prolactin, Estradiol, Cortisol, Progesterone, Testosterone, Folate, Vitamin B-1, Ferritin,Tumor markers ( AFP, PSA, CEA, CA-15, CA 19-9, CA 15-3, BHCG,..) Serology/Virology Tests; WWF, RA factor, ASOT, VDRL, Anti-HIV, HBs Ag, Anti HCV, Rubella, Toxoplasma, CMV, HSV I, HSV II, Mycoplasma, Leptospira, Dengue, HIV, Hep B, Hep C, ASMA, AMA, ANA, DsDNA, Monospot, P-ANCA, C-ANCA, and etc Clot activator & Gel. Mix thoroughly by inversion times. Let the blood clot properly before proceed onto another step. Gold Yellow Information. Issue 1 / Jan Information. Issue 1 / Jan 015 1

10 ACD Solutions Tubes K EDTA With Gel Tubes TUD ACD solutions tubes are used in immuno-haematology or blood bank units to preserve red blood cells. TUD K EDTA With Gel are used for plasma separator purpose ACD.A EDTA K / Gel ACD.B EDTA K / Gel 8.5 Used as an anticoagulant to preserve blood specimens required for tissue typing, it is also used during procedures such as plasmapheresis instead of heparin. Acid Citrate Dextrose A & B. Used for whole blood determinations including HLA B7 testing/ flow cytometry/ tissue typing assays. EDTA binds calcium ions and blocks the coagulation cascade. These tubes, which upon centrifugation separate undiluted plasma, are used for testing plasma in molecular diagnostics and viral load detection. EDTA K & Gel. For use in molecular diagnostic test methods (such as, but not limited to, polymerase chain reaction [PCR] and/or branched DNA [bdna] amplification techniques.) Proper inversion times. N / A Light Yellow Sterilization by radiation Proper inversion times. 1g 1500g for 10 minutes at 5 C Room Temperature White Sterilization by radiation Information. Issue 1 / Jan Information. Issue 1 / Jan

11 Order of Description TUD Sodium Citrate 3.% TUD Sodium Citrate 3.8% (0.109M) (0.19M) Tube Materials / / Conditions Clotting Period Sample 3-/ 3-/ : xg (RCF) for mins at 5 : 1500xg (RCF) for mins at 5 Available Size (mm x mm) Inner Pack Size Per Carton 0 0 Color Symbols Citrate TUD ESR Tubes NC (0.109M) WB 10.5*10 / 8*10 0 TUD ESR Tubes (0.19M) / WB / /50 0/600 EC Representative This way up In Vitro Diagnostic TUD ACD Solutions ACD / WB/ /50 0/600 TUD Plain Tubes Silica/(No ) 1300xg (RCF) for mins at 5 30/60 mins SERUM / / / 0/ /50 0/ 600 TUD Gel & Clot Gel & Silica xg (RCF) for 8 mins at 5 30 mins SERUM / / / 0/ /50 0/ 600 Serum (No shall take before citrate) TUD Fast Clot Thrombin 1300xg (RCF) for mins at 5 5 mins SERUM / / / 0/ /50 0/ 600 Expiry Date Fragile Batch / Lot No. TUD Mini Gel Gel xg (RCF) for 8 mins at 5 30 mins SERUM 10.5*6 0 TUD Mini Plain Tubes None 1300xg (RCF) for 5 mins at 5 30 mins SERUM 10.5*6 0 TUD / Sodium / Sodium / / / 0/ /50 0/ 600 TUD Mini TUD With Gel &Gel 10.5*6 / 0 /50 0/ 600 Protect from sunlight Protect from rain / water Single use only TUD Mini With Gel &Gel 10.5*6 0 Haematology TUD K EDTA TUD K3 EDTA TUD Mini K3 EDTA EDTA K EDTA K3 EDTA K3 W B W B W B / / / / 10.5*6 / 0/ /50 0/ 600 / 0/ /50 0/ LH 9NC NC NA Trisodium Citrate 9:1 Trisodium Citrate :1 Sodium TUD Mini EDTA K EDTA K W B 10.5*6 0 Plasma Separator TUD EDTA With Gel TUD NaF Oxal EDTA & Gel Fluoride / Oxalate / / /50 0/ K NAF ACD OXAL Glucose TUD NaF EDTA Fluoride / EDTA K / / / 0/ /50 0/ 600 Potassium Sodium Floride Acid Citrate Dextrose Oxalate TUD Mini NaF EDTA Fluoride / EDTA K 10.5*6 0 Information. Issue 1 / Jan Information. Issue 1 / Jan

12 Compliances Corporate Responsibilities TUD Blood Collection Tubes are (non Annex II) In Vitro Diagnostic Medical Devices. These comply with the requirements described in the European In Vitro Diagnostic Manage the business with full and high responsibly Sustaining our commitments and ensure it remain as a responsible of our company Growing the business by offering quality consistency and better preventive products Medical Device Directive 98/79/EC. All products are designed and manufactured in accordance with the relevant international Social Responsibility and or European standards. This includes but is not limited to ISO 6710, EN180 (for blood collection tubes), EN 980 (for symbols used on product labelling). The product shelf life is based on data from stability testing and varies from product to product. All expiry dates are clearly printed on PHILOSOPHY To create awareness and sensitivity of the company to their employees, customers and communities shareholder and other stakeholders. Voluntary contributions are expected to create and cultivate positive social values not only to employees of TUD, but also to society as a whole and the value creation is aimed at all stakeholders. THE WORKPLACE We draw our employees from society and so everything we do with our staff needs to be socially responsible, whether we are dealing with basic human rights or gender issues. A quality work environment and health & safety are obvious considerations, as is the way in which, if we believe in CSR, we inculcate in our employees, the values which the company holds dear. Ideally, companies should consider all CSR dimensions when crafting their own visions. But that does not mean a company must do everything. TUD was very strict in meeting the needs and rights of workers from all aspects such as rates of pay, job security, compensation, respect, truthful communication. FRAMEWORK SMART is a measure of our framework to ensure the success of programs that benefit all stakeholders. Simple Measurable Achievable Reliable Time-bound product unit labels, and are valid until the end of the month specified. Our products are certified by ISO 1385, IQNET, MALAYSIA BRAND, EC Certification and with all relevant country CFS. Responsibility Our products consist all the aspect of the international materials guideline, the quality and specification of the products made according to the international reference which been certified by international certification body. Control of quality and safety for every batch of production. Appropriate use of International Reference Materials by national control laboratories or designated laboratories and manufacturers. The responsibility of promoting the quality products. Information. Issue 1 / Jan Information. Issue 1 / Jan 015 0