ate ee The Finecare™ TSH Rapid Quanttatve Testis a fluorescence immunoassay used along with Finecaro"™ FIA Systom (Model No.: FS-112/FS-113FS-206) for quantitative determination of thyroid stimulating hormone (TSH) in human whole ood, serum or plasma, This testis used as an ald to assistin the assessment of pituitary gland ane thyroid function, For n vio diagnostic use only. For professional use ony. SUMMARY Thyrold-stimulating hormone (also known as thyrotropin, thyrolropic hormone, TSH, or NTSH for human TSH) isa pitutary hormone thal stimulates the thyroid ‘land to produce thyroxine (T4), and then tiedothyronine (T3) which stimulates the metabolism of almost every tissue in the body. TSH is produced when the hypothalamus releases a substance called thyrotropineleasing hormone (TRH). ‘TRH then triggers the pituitary gland to release TSH. Its a glycoprotein hormone synthesized and secreted by thyrorope calls in the anterior pituitary gland, which regulates the endocrine function ofthe thyroid, ‘The determination of TSH levels is recognized as an important measurement in the assessment of thyroid function PRINCIPLE ‘The Finecare™ TSH Rapié Quantiatve Test is based on fuorescence immunoassay technology. The Finecare™ TSH Rapid Quanttative Test uses a ‘sandwich immunodetection method. When sample is added into the sample well of the Test Carriage, the Nuorescencedabeled detector TSH antibodies on the ‘sample pad bind to TSH antigens in blood specimen and they form immune complexes. As the complexes migrate onthe nivocelulose matrix of test stip by apilary action, the complexes of detector antbodies and TSH are captured to ‘TSH antibodies that have been immobilzed on test stip. Thus the more TSH “antigens in blood specimen, the more complexes accumulated on tet strip. Signal TSH Rapid Quantitative Test Catalog No. W220 intensity of fuorascence of detector antibodies reflect the amount of captured TSH. 1. For in vio diagnostic use only, 2 Careful folow the instructions and procedures described in this inser Lot numberof al the test components (Test Cartridge, ID Chip and Detection Buffer) must match with eachother. 4. Do not interchange the test components from different lots or use the test ‘components beyond the expiration date printed on package. '5, The Finecare™ TSH Rapid Quantitative Test kit is only operated in Finacare™ FIA System. Tests shouldbe applied by professionally trained staff working in ‘ceries laboratories and cris at which the sample(s) is taken by qualified medical personne 6. The Test Cartridge should remain ints original sealed pouch uni use, Do not Use the Test Caridge ihe pouch is damaged or aeady opened. 7. A Detection Buffer vial and Pipette Tip should be used for processing one sample only. Similarly a Test Cartridge should be used for testing one processed sample only, Bath the Detection Buffer vial as well as the test cartridge should be discarded after single use. 18 The Test Cartridge and Finecare™ FIA System should be used away from vibration analor magnetic fed. During normal usage, the Test Carre may reduce minor vibrations which shouldbe regarded as normal 9. Do not smoke, eat, oF drinkin the areas where specimens or test reagents being handled, 10, Blood specimens, used Test Cartidges, Pipette Tips and Detection Buffer Vials are potential infectous. They should be handled carefully and disposed (of by an appropriate method in accordance with relevant local regulations 11, The Finecare™ TSH Rapid Quanttative Test should not be used as absolute evidence for thyroid disease, The results should be interpreted by the ‘physician along with cnical ndings and other laboratory test results 12, The test should be applied ona routine basis but notin emergency situations.(MATERIAL, = 2 (Material Provided Components of Finecare™ TSH Rapid Quantitative Test: ‘Test Cartridge ina sealed pouch with desiccant 25 #10 Chip 1 «= Detection Bufer 2B ‘= Pipetio Tip 2 «© Leatet with Instructions for Use 1 [Material Required But Not Provided ‘ Finecare™ FIA System ‘Transfer Pipeto Set (100 pL size) ‘Specimen Collection Containers « Centrifuge (for serumiplasma specimen only) Timer 4. Store the test kit at 4 °C~30 °C upto the expiration date printed on package. 2. if removed from refrigerator, allow the test kt for 30 minutes to return to room temperature before testing 3, Do not remove the Test Cartridge from the pouch unl use. The Test Cartridge should be used within 1 hour onee opened 'SPECIMEN COLLECTION AND PREPARATION ‘The test can be performed wth ether serum or plasma or whale blood, For Whole Blood Collected by Venipuncture: 1. According to standard phlebotomy procedure, collect a venipuncture whole blood specimen with a blood collecton tube which contains. sultable anticoagulant. (EDTA, Heparin, Sodium Citrate) 2. Itis recommended that specimens shouldbe ested immediately. Do not leave the specimens at room temperature for prolonged period. I the specimens not tested immediatly, they should be kept at 2°C~8 °C. 3. Its not suitable to test the whole blood specimen which have been kept at 2°C ~8°C for more than 2 days, For Serum and Plasma: 1. According to standard phlebotomy procedure, collect @ venipuncture whole blood specimen. if you need to colect plasma, use a blood collection tube which contains suitable anticoagulant (EDTA, Heparin, Sodium Citrate). 2, Separate the serumiplasma from blood as soon as possible to avoid hemolysis ‘Test should be performed immediately ater specimen collection. Do not leave the specimens at room temperature for prolonged period. Specimens should be kept at 2“C-8°C for up to 7 days. For long time storage, specimens should ‘be kept below -20°C. Note: Bring specimens to room temperature before testing. Frozen specimens must be completely thawed and mixed well prior to testing Specimens should not be frozen and thawed repeatedly. Only clear, rnon-hemolytic specimens can be used. ‘TEST PROCEDURE For complete information and operating procedures, please refer to Finecare™ FIA System Operation Manual. Test shouldbe performed at room temperature. ‘Step 1: Preparation Before testing, activate use" in setting then save it Ensure thatthe lt number of the Test Cartridge matches ID Chip as well as the Detection Bute. insert ID Chip into Finecare™ FIA System. ‘Step 2: Sampling Draw 75 pL of whole blood or serum or plasma with a transfer pipette and add into the Detection Buffer tube, ‘Step 3: Mixing Close the ld of Detection Buler tube and mix the sample mixture thoroughly by ‘shaking it about 10 times. ‘Step 4: Loading Pipette 75 uL of sample mixture and load it into the sample well of the Test Cartridge. ‘Step 5: Testing “There are two test modes for Finecare™ FIA System, Standard Test mode and (Quick Test mode, Please refer tothe Operation Manual of Finecare™ FIA System for details 28) For Standard Test mode: Insert the Test Carridge onto the Test Carridge holder of Finecare™ FIA System right after adding sample mixture to the sample well Press ‘Test’ to start testing. (Apply to FS-112, FS-113 and FS.206) ) For Quick Test mode: Set the tier and count down right after adaing ‘sample micur into the sample well and leave it at room temperature for 15‘minutes. Then insert the Test Cartridge onto the Test Cartridge holder of Fingcare™ FIA System. Press "Test" to start testing. Finecare™ FIA System will start scanning the sample-oaded Test Carridge immediatly (Apply to FS-112 and FS-113) Results are cisplayod on main screen or be printed by press “Print” Discard the used Test Cartridge according to local regulations and procedures ‘aftr released from Finecare™ FIA Systom, INTERPRETATION OF RESULTS : tes: “The Finecare™ FIA Systom calculates TSH test results automatically and deplays the exact concentrations of TSH on the sereen as form of XXXXX mIUIL. For further information, please refer to the Operation Manual forthe Finecare™ FIA ‘System, Normal Reference Value: 0.3-8.2 miUIL Note: Recommend that each laboratory formulates its own reference range according to actual situation. ‘QUALITY CONTROL | amis = st Each Fingcare™ TSH Rapid Quanttatve Test Cartridge contains intemal contro! that satisles routine qualty contol requirements. This intemal contol is performed each time when a patient sample is tested. This contr indicates that the Test Cartridge was inserted and read properly by Finecare™ FIA System, An invalid result rom the intemal contol causes an error message on Finecare™ FIA, ‘System indicating thatthe test should be repeated LIMITATIONS OF PROCEDURE 1. This test has been developed for testing human whole blood, serum, plasma specimen only. 2, The test procedure, precautions and interpretations of results for ths test must be followed when testing ‘3. The results of Finacare™ TSH Rapid Quantitative Test shouldbe evalusted with all availabe cnical and laboratory data. 4, The false postive results include cross-reactions with some components of serum from individual to antibodies; and non-specific adhesion of some ‘components in human blood that have similar epitopes to capture and detector antibodies. inthe case of false negative results, the most common factors are: ‘ron-responsiveness of antigen to the antibodies by that certain unknown ‘components are masking its epitope, such that antigen cannot be seen by the antibodies; instability of TSH antigen, resulting in degradation with ime and, or temperature, such that they become no longer recognizable by antibodies; and degraded other test components. The effectiveness of the test is highly ‘dependent on storage of kts and sample specimens at optimal conditions, 5, Other factors may interfere wih Finecare™ TSH Rapid Quantitative Test and may cause erroneous results. These include technical or procedural errors, as wall as additions! substances in blood specimens. PERFORMANCE CHARACTERISTICS Accuracy ‘A comparative study Is tested for 409 cnical samples in using Finecare™ TSH Rapid Quanitatve Test anc the Roche TSH Reagent Kit ‘The Comelaion Coefficient (R'is 0.9838. ‘Assay Range and Detection Limit ‘+ Assay Range: 0.1~100 IU ‘* Detection Limit (Analytical Sensitivity): 0.1 miUiL (Cross-Reactivity ‘The following substances do not interfere withthe TSH test results atthe indicated ‘concentrations: FSH at 200 miUimL, LH at 200 miUimL, hCG at 1000 mim. “The folowing substances do not interfere with the TSH test results atthe indicated ‘concentrations: cholesterol at 60 mgimiL, blrubin at 2 mg/mL. tiglyoerides at 40.0 ‘mg/mL and hemoglobin at 10.0 maim. Linearity Five concentrations of TSH contol from 0.1~100 miIUN. were each tested for three times with one batch of tests, the Correlation Coetcient (R) is 0.9900, Precision Intra-Lot Precision: Determined by using 10 Test Cartidges in the same batch to test with TSH contro. C.V. is 15%,Inter-Lot Precision: Determined by using 3 Test Carvidgesin3 random and continuous batches to test with TSH control. CV. ie 518% BIBLIOGRAPHY OF SUGGESTED READING 1. The American Herage Dictonary of the English Language, Fourth Edlon, Houghton Mifin Company. 2006. ISBN 0-395-82517-2, 2. Sacher R, Richard A. McPherson (2000). Widmann's Cinical Interpretation of Laboratory Tests, 11th od. FA. Davis Company. ISBN 0-8036-0270.7. 8. Brabant G, Prank K, Ranft U, Schuermeyer T, Wagner TO, Hauser H, Kummer B, Feisiner H, Hesch RD, von zur MUhien A (Feb 1990). “Physiological ‘equation of ccadian and pulsatile thyrotropin secretion in normal man and ‘woman’. The Journal of Clinical Endocrinology and Metabolism 70 (2) 403-9, 4. Burger, H. G., Patel, Y.C. Thyrotropin releasing hormone-TSH. Cini, Endocrinol. Metab. 1977, 6831-00 INDEXOF SYMBOLS in viro See ston WD] Score e || CTE) ise \/| Tess pert TOT]| est numver | |=T=]] Autores AR | eepawer tom ®@ Manutacting oy Keep Ory Representative ‘Sunlight ‘tre between sm0C ee ‘Guangzhou Wondlo Biotech Co. Ltd ‘No Lizhshan Road, Science ity, Luogang District, ‘510663, Guangzhou, PAR. Ching CE arrrnvns ‘Gpalstraat 3 5.2440 Geel, Belgium Rev. At Rel: 2018/01/11