自從1992年建立以來，Trinity Biotech 公司繼續(xù)積極從事于診斷行業(yè)，目標是成為一個*者。強有機的增長和不斷進步的戰(zhàn)略模式見證了公司的榮譽。 迄今為止Trinity Biotech 公司組裝過的組合已經(jīng)超過了400種。

專業(yè)發(fā)展于診斷器材的銷售和制造， 三一生物技術(shù)的持續(xù)成功依賴于公司始終如一的質(zhì)量標準。

Trinity Biotech公司生產(chǎn)測試套件主要用于

臨床實驗室和臨時診斷市場細分的探測傳染病、性傳播疾病、自身免疫和血紅蛋白疾患、探測、監(jiān)視和控制糖尿病方面。

公司也是生命科學行業(yè)理重要的原材料供應商。

從納斯達克交易所獲悉,三一生物技術(shù)產(chǎn)品已經(jīng)橫跨歐洲和美國熱銷于世界上75個國家。通過自身的技能和網(wǎng)絡銷售能力已經(jīng)與世界各地的分銷商形成了戰(zhàn)略伙伴關(guān)系。

 TRINITY 公司是的臨床診斷試劑及臨床免疫類儀器生產(chǎn)供應商，*納斯達克上市的醫(yī)藥企業(yè)。公司商業(yè)總部位于愛爾蘭都柏林，在紐約Jamston, California,,英國warehouse, 德國，加拿大，瑞典均設有生產(chǎn)基地。自1992年成立以來，已在收購十多家醫(yī)藥生物公司。其產(chǎn)品范圍包括自身免疫性疾病的診斷，激素類診斷試劑，藥物監(jiān)測，性傳播疾病和傳染病血清學診斷，及臨床血液部門檢測（Sigma）,臨床凝血檢測（Biopool）。

Trinity Biotech的制造設備基地如下：

布雷,愛爾蘭-急流,傳染病　　

卡爾斯巴德,美國-傳染病,免疫印跡,現(xiàn)階段的發(fā)展　

阿克頓,美國-原材料供應的研究和診斷行業(yè)　

詹姆斯敦,美國-傳染病——酶免疫測定（EIA） 　　

堪薩斯城,美國--基于液相色譜Boronate親和力糖尿病診斷

 Lipase

The measurement of serum lipase activity is widely used for the diagnosis of acute pancreatitis.

METHOD Kinetic, Enzymatic

PRINCIPLE

The rate of increase in absorbance at 550 nm due to the formation of quinone diimine dye is directly proportional to the lipase activity in the sample.

*N-Ethyl-N-（2-hydroxy-3-sulfopropyl）-m-toluidine

DIAGNOSTIC IMPLICATIONS A 10-fold increase of lipase activity above the upper reference limit is suggestive of pancreatitis, pancreatic injury, or inflammation of organs contiguous to the pancreas. It is recommended that other tests, such as trypsinogen and amylase isoenzymes be performed to supplement the diagnosis.

PRODUCTBRANDCODEKIT

Lipase PS: Kit （166 assays）Trinity Biotech80Maximum Assays: 166

Lactate

Lactic Acid is a by-product of carbohydrate metabolism. Blood lactate arises primarily from muscle cells and erthrocytes and is metabolised by the liver. Therefore, blood lactate levels reflect both production and metabolism.

METHOD Enzymatic, Colourimetric

PRINCIPLE Lactic acid is converted to pyruvate and the H2O2 （Hydrogen Peroxide） by lactate oxidase. In the presence of the H2O2 formed, peroxidase catalyzes the oxidative condensation of chromogen precursors to produce a coloured dye with an absorption maximum at 540 nm. The increase in absorbance at 540 nm is directly proportional to lactate concentration in the sample.

DIAGNOSTIC IMPLICATIONS Normal lactate acid levels are 4.5-19.8 mg/dL. Elevate lactate acid levels can result from severe tissue oxygen deprivation leading to ‘lactic acidosis’ characterised by weakness, stupor, fatigue and coma. Lactate measurement can also be useful clinically in the diagnosis of angina pectoris or in liver function testing where reduced liver function is suspected.

PRODUCTBRANDCODEKIT

Lactate Kit: Reagent 10 x 10mLTrinity Biotech735-1010x10 ml

Lactate Kit: Standard Solution 40 mg/dlTrinity Biotech826-1010 ml

Lactate Kit: Standard SetTrinity Biotech735-11

Lactic Acid is a by-product of carbohydrate metabolism. Blood lactate arises primarily from muscle cells and erthrocytes and is metabolised by the liver. Therefore, blood lactate levels reflect both production and metabolism.

METHOD Enzymatic, Colourimetric

PRINCIPLE Lactic acid is converted to pyruvate and the H2O2 （Hydrogen Peroxide） by lactate oxidase. In the presence of the H2O2 formed, peroxidase catalyzes the oxidative condensation of chromogen precursors to produce a coloured dye with an absorption maximum at 540 nm. The increase in absorbance at 540 nm is directly proportional to lactate concentration in the sample.

DIAGNOSTIC IMPLICATIONS Normal lactate acid levels are 4.5-19.8 mg/dL. Elevate lactate acid levels can result from severe tissue oxygen deprivation leading to ‘lactic acidosis’ characterised by weakness, stupor, fatigue and coma. Lactate measurement can also be useful clinically in the diagnosis of angina pectoris or in liver function testing where reduced liver function is suspected.

PRODUCTBRANDCODEKIT

Lactate Kit: Reagent 10 x 10mLTrinity Biotech735-1010x10 ml

Lactate Kit: Standard Solution 40 mg/dlTrinity Biotech826-1010 ml

Lactate Kit: Standard SetTrinity Biotech735-11

Blood total cholesterol levels have long been known to be related to coronary heart disease （CHD）. Total Cholesterol count is composed of LDL, HDL, along with triglycerides and Lp（a） cholesterol.

HDL （High Density Lipoprotein） EZ LDLTM Homogeneous Method

High Density Lipoprotein Cholesterol （HDL-C） has become an important tool used to assess an individual’s risk of developing CHD since a strong negative relationship between HDL-C concentration and the incidence of CHD has been reported. Most clinical laboratories routinely perform HDL-C analysis. The Trinity Biotech EZ HDL Cholesterol test employs the use of a specific antibody, and thus, can be applied on automated analysers.

METHOD Colormetric, immunological procedure for automated analysers.

PRINCIPLE Anti-human ß-lipoprotien antibody binds to lipoproteins （LDL, VLDL and chylomicrons） other than HDL cholesterol （HDL-C）. The antigenantibody complexes formed block enzyme reactions when the enzymatic cholesterol reagent is added. Cholesterol esterase and cholesterol oxidase react only with HDL-C. Hydrogen peroxide produced by the enzyme reactions with HDL-C yields a blue colour complex upon oxidase consideration with FDAOS （N-ethyl-N-2hydroxy-3-sulfopropyl）-3, 5-dimethoxy, 4-Fluoroanaline sodium salt and 4-aminoantipyrine in the presence of peroxidase.

By measuring the absorbance of the blue colour complex produced at approximay 600 nm, the HDL-C concentrationin the sample can be calculated when compared when the absorbance on the calibrator.

DIAGNOSTIC IMPLICATIONS About one-fourth to one-third of blood cholesterol is carried by high-density lipoprotein （HDL）. HDL cholesterol is known as ‘good’ cholesterol, because high levels of HDL seem to protect against heart attack. Low levels of HDL （less than 40 mg/dL） also increase the risk of  heart disease. Medical experts think that HDL tends to carry cholesterol away from the arteries and back to the liver, where it is passed from the body. Some experts believe that HDL removes excess cholesterol from arterial plaque, thus slowing its build up.

PRODUCTBRANDCODEKIT

EZ HDL: Cholesterol Kit （444 assays - low vol）Trinity Biotech354LBMaximum Assays: 444

EZ HDL/LDL™ Combination CalibratorTrinity BiotechE02774 x 3ml

Lyophilized control containing G-6-PDH in a stablised human red cell hemolysate.

PRODUCTBRANDCODEKIT

G-6-PDH Control, DEFICIENTTrinity BiotechG58886x0.5 ml

G-6-PDH Control, INTERMEDIATETrinity BiotechG50296x0.5 ml

G-6-PDH Control, NORMALTrinity BiotechG68886x0.5 ml

METHOD Spot Test, Visual Fluorescence （qualitative）

PRINCIPLE

The reaction mixture containing glucose -6-phosphate+NADP （Not Fluorescent） and blood is incubated and, at timed intervals, drops of the mixture are applied to filter paper. The spots are visually inspected under long-wavelength （320-420nm） ultraviolet light. The observed rate of appearance of bright Fluorescence is proportional to the blood G-6-PDH activity.

PRODUCTBRANDCODEKIT

G-6-PDH Screening Test KitTrinity Biotech203-AMaximum Assays: 50

METHOD Dye Reduction, Visual Colour （qualitative）

PRINCIPLE

The rate at which the colour visually disappears in the reaction mixture is proportional to the G-6-PDH content of red cells.

PRODUCTBRANDCODEKIT

G-6-PDH Trizma Buffer SolutionTrinity Biotech400-4-5050 ml

G-6-PDH Dye Reduction Kit （5 assays/vial）Trinity Biotech400K-100-5X20Maximum Assays: 100

G-6-PDH Mineral Oil 1 LiterTrinity Biotech400-5-10001 L

G-6-PDH Dye Reduction Kit （10 assay/vial）Trinity Biotech400K-100XMaximum Assays: 100

G-6-PDH Mineral Oil - 100 mlTrinity Biotech400-5-100100 ml

G-6-PDH 10-Assay Vial （10 vials）Trinity Biotech400-10x1010 vials

G6PDH Substrate Kit 5 Tests/ VialTrinity Biotech400-5x1010 Vials

Glucose-6-Phosphate Dehydrogenase （G-6-PDH） is an X-linked disorder is the most common type of haemolytic anaemia due to an intrinsic red cell enzyme defect.

Males who inherit an abnormal gene are invariably affected. Heterozygote females usually have approximay 50% G6PD enzyme activity; the random Lyonisation of X chromosomes means that rarely carrier females may be severely affected. It is most common in the Mediterranean, the Middle East, South East Asia and West Africa. It is rare among Caucasians.

METHOD Ultraviolet, Kinetic （quantitative）

PRINCIPLE

The rate of formation of NADPH is proportional to the G-6-PDH activity is measured spectrophotometrically as an increase in absorbance at 340nm.

DIAGNOSTIC IMPLICATIONS Presentation is usually with an acute episode of intravascular haemolysis on exposure to certain drugs, infection or acute illness. Mediterranean forms may present with neonatal jaundice. The condition is also known as favism as sudden haemolysis may be precipitated by the ingestion of fava beans – Vicia faba. The deficiency is generally less severe in Africans and favism is rare in this population.

PRODUCTBRANDCODEKIT

G-6-PDH kit （50 assays）Trinity Biotech345-BMaximum Assays: 50

G-6-PDH kit （20 assays）Trinity Biotech345-AMaximum Assays: 20

G-6-PDH Red Cell Lysing ReagentTrinity BiotechR11294x25 ml

PRODUCTBRANDCODEKIT

Lp（a） – Additional automation componentsMacra®AT910096 tests

Macra® Lp（a）Macra®233910096 tests

The test for serum bile acids will detect liver changes before the formation of more advanced clinical signs of illness. This early sensitivity is very important to the practitioner because it allows for the possibility of treatment before extensive and irreversible damage is done.

Bile Acids are indicators of a liver function. However, the test will not provide a definitive diagnosis of the primary problem, merely an early confirmation that there is a hepatobiliary deficiency.

There are a large number of diseases that can compromise hepatobiliary function in a primary or secondary manner.

METHOD Colormetric, Enzymatic

PRINCIPLE

The intensity of the colour produced by the action of 3a -hydroxsteroid dehydrogenase （3a -HSD） and diaphorase is directly proportional to the bile acids concentration in sample.

DIAGNOSTIC IMPLICATIONS Liver diseases that can elevate bile acid levels include hepatic neoplasia, portosystemic shunt, hepatitis, bile duct obstruction, canine adenovirus, slowed gastrointestinal transit and almost any condition that causes a defect in hepatic uptake or portal circulation. Test results that appear low are usually due to normal variation or prolonged fasting, but can also indicate intestinal malabsorption or increased gastric motility.

Normally, a small increase will be seen from the fasted to the post-prandial sample, however hepatobiliary disorders can cause elevated fasting and/or elevated post-prandial values.

PRODUCTBRANDCODEKIT

Bile Acid: KitTrinity Biotech450-A16x10 ml

Bile Acid: Reagent BTrinity Biotech450-21x5 ml

Bile Acid: ControlsTrinity Biotech450-226x5 ml

Bile Acid: Calibrator SetTrinity Biotech450-115x5 ml

Bile Acid: Stop ReagentTrinity Biotech450-350 ml

Bile Acid: Calibrator （100 umol/l）Trinity Biotech450-1005 ml

Bile Acid: Reagent ATrinity Biotech450-1-5050 ml

Bile Acid: Reagent BTrinity Biotech450-2-2525 ml

ACE系列：

Angiotensin Converting Enzyme （ACE） is a glycoprotein peptidlypeptide hydrolase.

METHOD Ultraviolet, Kinetic

PRINCIPLE

Furylacryloylphenylalanylglycylglycine （FAPGG） is hydrolyzed to Furylacryloylphenylalanine （FAP） and glycylglycine （GG）. Hydrolysis of FAPCGG results in a decrease in absorbance at 340 nm. The rate of decrease in absorbance at 340 nm is directly proportional to ACE activity in the sample.

DIAGNOSTIC IMPLICATIONS Elevated levels of ACE activity occur in serum of patients with active sarcoidosis, and occasionally in premature infants with respiratory distress syndrome, in adults with tuberculosis, leprosy and in many other pathologic conditions involving lung and liver diseases.

PRODUCTBRANDCODEKIT

ACE Kit: CalibratorTrinity Biotech305-506x1 ml

ACE Kit: ReagentTrinity Biotech305-1010x10 ml

ACE Kit: Control - NTrinity BiotechA60406x1 ml

ACE Kit: Control - ETrinity BiotechA70406x1 ml