TRIGLYCERIDES
Contents
1. 3ini TRIGLYCERIDES Reagent strips for the determination of Triglycerides concentration To be used only with the 3in1 Instructions for use Introduction Using the 3in1 Triglycerides strips it is possible to quickly check triglycerides levels in the blood The level of triglycerides in the blood is influenced from fat feeding or from alterations of the metabolism of lipids but also from diabetes mellitus nephrotic syndromes pancreas problems acute alcoholism It is important to inform the family physician to find a suitable therapy or to check up on an existing therapy Perform the test when you have not had anything to eat or drink except water for at least 12 hours Test principle The test is based on Lipase Glycerol Kinase Phosphate Oxidase Glycerol Peroxidase Cromogen reaction The intensity the colour develops from the reaction is proportional to the concentration of triglycerides in the blood Composition The reactive area of each strip contains chromogen min 0 017 mg Lipase 1 02 IU Glycerol 3 phoshate Oxidase 0 31 IU Glycerol Kinase 0 41 IU Peroxidase 1 2 IU Procedure e Open the pack of 3in1 Triglycerides strips pull out the data chip of yellow color e Insert the data chip into the proper space on the side of the meter picture 1 e Open the vial take a strip and immediately close it e Insert the strip in the strip holder of the meter picture 2 with the coloured side visible till to hear an acoustic si2. C 41 F and 86 F e Avoid exposing to excessive humidity do not freeze e Keep the 3in1 Triglycerides strips away from children e Do not perform any tests bellow 10 C 50 F or above 40 C 104 F e Do not touch reacting strips with polluting agents like for example dirty hands the results could be seriously altered e Use the strip immediately after removing it from the vial e Make sure the vial is properly closed after removing the strip and use its original cap containing siccative material Do not place the strips in a different container e The 3in1 Triglycerides strips must be used within and not after the expiry date on the package Once the vial has been opened use the strips within 3 months The reactive area on the strip is white in optimal conditions Do not use the strip if the reactive area has a different colour e Notes for doctors and labs e To measure the Triglycerides with the 3in1 system it is possible to use fresh capillary blood Do not use serum or plasma on the strip Limitations e If the value of triglycerides after testing does not correspond to the normal sensations felt by the patient and to the basic knowledge of health conditions and symptoms repeat the test Read the user manual to verify the correct determination procedure and consult your physician e The result is affected by high levels of hemoglobine bilirubin and ascorbic acid e Inaccurate results can be obtained at high altitudes since
3. glycerides 3in1 Triglycerides Control Solutions and by following the included instructions The expected results for this test are printed on the vial s label of the 3in1 Triglycerides strips that are being used Storage and expiry date Keep the reactive strips at temperatures between 5 C 41 F and 30 C 86 F and keep them in the original Do not expose to direct sun light Close the vial with the original cap immediately after pull out the strip In this way the strips will last up to 3 after the first opening The expiry date on the package of strips refers to a new unopened vial The use of expired strips can cause wrong results Do not expose to excessive humidity Do not freeze Table of results displayed Below 50 mg dL 0 5 mmol L LO Between 50 mg dL 0 5 mmol L and 500 mg dL 5 6 mmol L the numerical result Above 500 mg dL 5 6 mmol L HI Repeat the test Such results mean that the Triglycerides concentration in the sample is very elevated and it indicates a serious risk Triglycerides values Less than 150 mg dl 1 7mmol L Normal Borderline High 150 199 mg dL 1 7 2 2 mmol L High 200 499 mg dL 2 3 5 6 mmol L Very High 500 mg dL 5 6 mmol L or above The analytical results have to be communicated to the physician Warnings e Long exposure to air and light can alter the results It is recommended to keep the strips in the original vial with the cap at room temperature between 5 and 30
4. gnal bip e Check that TGL symbol appears on the display and check that the number on the strip vial label is the same of the one on the display picture 3 e wash the hand with hot water and massage the finger that you choose for the pricking to increase the blood flow Let your arm hang down for about one minute e execute the puncture of the finger using the lancing device and a sterile lancet e remove the first drop with a sterile gauze and gently press the finger to obtain a second drop 10 microliters e approach the pricked finger with the drop of blood to the lower part of the strip picture 4 itis the part that come out of the instrument The sample of blood will be automatically aspirated by the strip Do not remove the finger until the moving segments will appear on the display the instrument will emit an acoustic signal bip e After some seconds the result will be displayed e Use the ejector key on the backside of the meter to remove the used strips in order to avoid contaminations Only one measurement has to be carried out for each finger pricking Carefully follow the instructions contained in the user manual All components of the pack has to be disposed properly avoiding contaminations To apply the drop of blood Testing the system A check up of the users skills the correct working of the 3in1 Triglycerides instrument and its strips must be periodically carried out through the use of the Tri
5. the concentration of oxygen is lower e Abnormal values of hematocrit higher than 50 or lower than 30 can influence the results e Minimum volume of blood sample 10 uL Accuracy The average error of the 3in1 Triglycerides system compared to the reference method GPO is lt 10 In aseries of measurements performed in a hospital the following linear regression has been obtained y 0 9814x 3 8374 Precision Repeatability the average inaccuracy is lt 5 in a series of measurements performed in laboratory an average coefficient of variation of 4 66 was obtained Reproducibility the average inaccuracy is lt 5 in a series of measurements performed in laboratory an average coefficient of variation of 4 62 was obtained References Onat A Sari Yazici M Can G Hergenc G Avci GS Plasma triglycerides an independent predictor of cardiovascular disease in men A prospective study based on a population with prevalent metabolic syndrome Int J Cardiol 2005 Aug 4 Epub ahead of print CE CE mark z Use until Control Solutions In Vitro LOT IVD Batch number Level 1 Diagnosticum 4 Store at A Follow instructions Level 2 CUSTOMER SERVICE al VPD Bled d o o 386 457 45 070 Pot na Lisice 4 4260 Bled Slovenia tel 386 4 574 50 70 fax 386 4 574 50 71 In vitro diagnostika IN TGL ED2009 REVO1 E SL
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