Revision date: March 16,2021 (Rev03} ichromea™ TSH Ichroma™ TSH isa fluorescence Immunoassay (FIA) for the {quantitative determination of TSH in human serum/olasma. It is useful as an aid in management and monitoring of measurement in the assessment of thyroid function For in vitro diagnostic use only nea The determination of serum or plasma levels of thyroid stimulating hormone (TSH or thyrotropin) is recognized as an important measurement in the assessment of thyroid function. Thyrotd stimulating hormone is secreted by the anterior lobe of the pituitary gland, and induces the production and release of thyroxine (4) and ‘wiiodothyronine (73) from the thyroid gland. It is a lycoprotein with a molecular weight of approximately 28,000 daltons, consisting of two chemically different ‘subunits, alpha and beta. Although the concentration of TSH in the blood is extremely low, it is essential in the maintenance of normal thyroid function. The release of TSH is regulated by a TSH-releasing hormone (TRH} produced by the hypothalamus. The levels of TSH and TRH are inversely related to the level of thyroid hormone. When there isa high level of thyroid hormane inthe blood, les TRH is released by the hypothalamus, o less TSH is secreted by the pituitary. ‘The opposite action will occur when there are decreased levels of thyroid hormones in the blood, This process, known ‘as a negative feedback mechanism, is responsible for ‘aintsining the proper blood levels of these hormones. fn The test uses a sandwich immunodetection method: the detector antibodies in buffer bind to antigens in the sample, forming antigen-antibody complexes, and migrate onto nitrocellulose matrix to be captured by the other immobilzed-antibodies on tes strip. More antigens in the sample will form more antigen- antibody complexes which lead to stranger fluorescence signal by detector antibodies, which is processed by instrument forichroma"™ tests to show TSH concentration in the sample Ee ichroma™ TSH consists of ‘cartridges, ‘detector vials, and ‘detector diluent” f= The cartridge contains the membrane called a test strip Which has anti human TSH at the test line, and chicken le¥ at the contra ine. All cartridges are individually sealed in an aluminum foil pouch containing @ desiceant in a box. The detector vials have lyophilized detection buffer containing anti human TSH fluorescence conjugate, anti- chicken Ig¥fluorescence conjugate, sucrose, mouse IgG, AI-GEO2-15 (Rev 04) bovine serum albumin (BSA) and sodium azide in phosphate buffered saline (PS). All detector vials are packed ina zipper bag 1 The detector diluent contains tween 20, triton X-100, and sodium aalde in potassium phosphate buffer (Kpi), and it is re-dispensed in vials. The detector diluent i packed in 2 zipper bag, Crna 1 For in vitro diagnostic use only ' Follow instructions and procedures described in this “instruction for use’ Use only fresh samples and avoid direct sunlight. It is possible to use frozen samples. Please refer to “SAMPLE COLLECTION AND PROCESSING.” Lot numbers of all the test components (cartridge, detector vial, detector diluent and (D chip) must match each other "= D0 not interchange the test _componer different lots or use the test components after the expiration date, elther of which might yield incorrect test result(s) = Do not reuse cartridges and sample mixing tubes. A cartridge should be used for testing one sample only. A sample mixing tube should be used for testing one sample only, 1 The cartridge should remain sealed in its original pouch unt just before use. Do not use the cartridge, if pouch is damaged or has alteady been opened. = Frozen sample should be thawed only onee. For shipping, samples must be packed in accordance with local regulations. Sample with severe hemolysis and/or hyperipidemia must not be used. 1 Allow cartridge, detector val, detector diluent and sample to_be at room temperature for approximately 30 minutes before use, 1 The instrument for Ichroma™ tests may generate slight vibration during use. Used cartridges, sample mixing tubes and pipette tips should be handled carefully and discarded by an appropriate method in accordance with relevant local regulations. 1 The detector vial and detector diluent contain NaNy as @ preservative, with which contact eyes, ski, or clothing should be avoided. It happens, please wash with running water immediately 1 An exposure to larger quantities of sodium azide may cause certain health issues like convulsions, low blood pressure and heart rate loss of consciousness, lung injury and respiratory fllure ' ichroma™ TSH will provide accurate and reliable results subject to the below conditions. = ichroma™ TSH should be used only in conjunction with the instrument for chroma™ tests, ave to use recommended anticoagulant sample. Recommended anticoagulant Sodium Heparin VsRevision date: March 16,2021 (Rev03) Bee ue cd Storage condition Storage Shelfife Component Temperature (months) __No%e Cartridge 4-30°C. 20 Disposable 430°C 20__Unopened Detector vial. —S-32°E “ repens ‘tector dive 30°C 20 Unopened) Detector dent 3-307 3 ‘Opened © Rte the detector diluent s added to the detector vial for reconstitution, itis stable for a month if stored at 4-30 °C with the lid closed, f= Aiter the cartridge pouch is opened, the test should be performed immediately, [nena 1 The test may yield false positive result(s) due to the cross reactions and/or non-specific adhesion of certain sample components to the capture/detector antibodies. 1 The test may yield false negative result(s} due to the non- responsiveness of the antigen to the antibodies which Is, ‘most common if the epitope is masked by some unknown components, so therefore not being able to be detected for captured by the antibodies. The instability or degradation ofthe antigen with time and/or temperature may also cause false negative result as it makes antigen unrecognizable by the antibodies. 1 Other factors may interfere with the test and cause erroneous results, such as technical/procedural errors, gradation ofthe test components/reagents or presence of interfering substances inthe test samples. 1 Any clisical diagnosis based on the test result must be supported by 3 comprehensive judgment of the concerned physician including clinical symptoms and other relevant test results ee fre crPc-22 ‘Components of ichroma™ TSH Cartridge Box: ED = Cartridge 25 Detector vial 2 = Detector diluent 1 = Sample mixing tube 25 = 1Dchip 1 ~ Instruction for use 1 Meee) Following items can be purchased separately from ichroma™ TSH. Please contact our sales division for more information. 1 Instrument for ichroma™ tests Ichroma™ Reader ichtoma™ 1! = Printer 1 Boditech TSH Control 1 Boditech Hormone Control RReF|FR203 iReF|FPRROza iReF|FPRROO7 RREFKrPo-228 IREFKPo-95 ‘QAL-GEO2-1S (Rev 04) Ena ene The sample type for ichroma™ TSH is human serum plasma, & Itis recommended to test the sample within 24 hours after collection, 1 The serum or plasma should be separated from the clot by centrifugation within 3 hours after the collection of whole blood. 1 Samples may be stored for 2 weeks at 2-8°C prior to being tested, If testing will be delayed more than 2 weeks, ‘samples should be frozen at-20 °C. 1 Samples stored frozen at 20°C for 3 months showed no performance difference. 1 Once the sample was frozen, it should be used one time only for test, because repeated freezing and thawing can result in the change of test values. TEST SETUP. 1 Check the contents of ichroma™ TSH: Sealed cartridges, detector vals, detector diluent, sample mixing tubes, ID chip. 1 Ensure that the lot number of the cartridge matches that of the detector vial, detector diluent as well asthe ID chip, 1 Ifthe sealed cartridge, the detector tube and the detector dluent have been stored in refrigerator, place them on a clean and flat surface at room temperature for atleast 30, minutes before testing. 1» Turn on the instrument forichroma™ tests, (Please refer to the ‘Instrument for ichroma™ tests Operation Manual’ for complete information and operating instructions.) men “Multi Mode> 4). Transfer 1,200 ul of detector diluent using a pipette to.a detector val Close the lid of the detector vial and allow it to stand for 30 minutes. Swirl gently before use. X Avoid formation of foam, Do not shake. ‘When the lyophilized form is completely dissolved in the val, t becomes detection buffer. Transfer 150 ul of sample (Human serum/slasmay control using a pipette to 2 sample mixing tube. ‘Add 75 UL of detection butfer to the sample mixing tube eontaining sample. Close the Iid of the sample mixing tube and mix the sample thoroughly by shaking it about 10 times. (The ‘sample mixture must be used immeciately) Pipette out 75 ul of a sample mixture and load it into the sample well on the cartridge. Leave the ‘temperature for 12 minutes. As Scan the somple-loaded cortridge immediately when the incubation time is over. If not, it wil cause inaccurate test result To scan the sample-loaded cartridge, insert it into the cartridge holder of the instrument for ichroma™ tests Ensure proper orientation of the cartridge before pushing it all the way inside the cartridge holder. An 27s sample-loaded cartridge at roomRevision date: March 16,2021 (Rev03) ‘arrow is marked on the cartridge especially for this, purpose. 0) Press the ‘Select’ or Tab the ‘START’ button on the instrument for ichroma™ test + the scanning process 11) Instrument for ichroma™ tests will start scanning the sample-loaded cartridge immediately. 12) Read the test result on the display screen of the instrument for ichroma™ tests, to sta 4) ‘Transfer 1,200 ul of detector diluent using a pipette toa detector via. 2) Close the rid of the detector val and allow itto stand for 30 minutes, Swiri gently before use. x Avoid formation of foam. Do not shake. 3) When the lyophilized form is completely dissolved in ‘the vial, t becomes detection butter. 4) ‘Transfer 150 4 of sample (Human serum/plasma/ contra using a pipette to 2 sample mixing tube. 5) Add 75 ul detection buffer to the sample mixing tube Containing sample 6) Close the lid of the sample mixing tube and mix the sample thoroughly by shaking it about 10 times. (The ‘sample mixture must be used immeciately} 7) Pipette out 75 uL ofa sample mixture and load it nto the sample well on the cartridge 8) Inserting the sample-loaded cartridge into the holder cof the instrument for ichroma” tests, Ensure proper orientation of the cartridge before pushing it all the ‘way inside the cartridge holder. An arrow is marked ‘on the cartridge especialy for this purpose. 9) Press the ‘Select’ or Tab the ‘START’ button on the instrument for ichroma™ tests to start the scanning process 0) The cartridge goes inside the Instrument for ichroma™ tests and the instrument for ichroma™ tests will automatically start scanning the sample- loaded cartridge after 12 minutes 1:1) Read the test result on the display screen of the instrument for icheoma™ tests [Mena 1 Instrument for ichroma™ tests calculates the test result automatically and displays TSH concentration of the test sample in terms of ulU/m. 1 Reference range Type TSH (aIU/mUy Adults 0,345.6 1» Working range :0.2-100 nlU/mL PU 1 Quality control tests are a part ofthe good testing practice to confirm the expected results and valicty of the assay and should be performed at regular intervals. 1 The control tests should be performed immediately after ‘opening a new test lat to ensure the test performance is not altered. ‘= Quality control tests should also be performed whenever there is any question concerning the validity of the test AL-GEO2-1S (Rev 04) results. 1 Control materials are provided on demand with ichroma”™ TSH. For more information regarding obtaining the control materials, contact Boditech Med Ine’s Sales Division for assistance (Please refer tothe instruction for use of control material) Ennead 1 Analytical sensitivity ~ Limit of Blank (LoB) 0.03 yl/m = Umit of Detection (LoD) 0.07 wlu/mt Limit of Quantification (Loa) (0.30 wlU/mt 1 Analytical specificity = Cross reactivity Biomolecules such as below the ones in the table were added to the test sampie(s) at concentrations much higher than their normal physiological levels in the blood, ichroma™ TSH test results did not show any significant cross-reactivity with these biomolecules, (Cross reactivity materials Concentration hes. 1,500,000 miU/mi ut 1,500 mIU/mL FSH 1,500 mIU/ml PRL 3,500 wlU/ml + interference Interference materials such as below the ones in the table were added to the test sample(s) the same as the below concentrations. Ichroma™ TSH test results did not show any significant interference with these materials except for sodium citrate. interference mate Concentration: Deglucose 60 mM scoroic acid 0.2mm Bilirubin 04 mM/L Hemoglobin Zeit Cholesterol 73 mw triglyceride 30mg/mt Sodium citrate Oi mM Sodium Heparin 15 1U/mL «= Precision 3 lots of ichroma™* TSH were tested for 21 days (7 days per Llotat 1 site by one operator). Each standard material was tested 2 times per day. For each test, each material was duplicated. ~ Repeatability (within-run precision) Repeatability of ichroma™ TSH was evaluated with result of Lot Total precision (within-laboratory) Total precision (within-laboratory) of ichroma™ TSH was evaluated within result of 1 lot, = Lot to lot precision Lot to lot precision of ichroma™ TSH was evaluated within results of 3 lots. ~ Between person Three different persons tested ichroma™ TSH; ten times at each concentration of the control standard = Between site One person tested ichroma™ TSH at three different 3/5Revision date: March 16,2021 (Rev03} sites; ten times at each concentration of the contol Standard 120 | -osesx- 0064 Con apes To SION 100 oseox 00 (uum) AVG vA CVD z 0 R=0.999 070 ot 578 07069 5 35347686 386 3 Cone. Lotto lot precision Between person 5 40 [ulu/emt)_ AVG CV (%) AVG CV (%) 20 or 070626 07 655 — 5 3535063735 ; 5 7 702642 7.00 5.40 9 setessZuuymy 10° 0 Cone betwee ten ave it | nerenenceS 070078 2 eS 1. Marshal, 1¢: Cn. n Endocrinol Meta, 1975, 4545 3 2. Burger HG, Pte ¥€ Thyotopin releasing hormone: ae TSH) cline, Endocrinol Metab. 197, 6851-00, The accuracy was confirmed by testing with 3 different ots of chroma” TSH. The tests are repeated 10 times in each diferent concentration TSH Cone. Recovery fiiuymyy ott Lotz tots ay See 0000 000 0.00 0.00 035035 0.34 0.34034 982 070.71 066 0.70 069 988 35333 342342339 96.8 7677 664 694678 969 3535.66 33.97 35.64 35,09 1003 7575.84 67.95 70.29 71.23 950 = Comparability TSH concentrations of 100 serum samples were quantified independently with ichroma™ TSH and Access? (Beckman Coulter Inc. USA} as per prescribed test procedures for each instrument. Test results were compated, and their comparability was investigated with linear regression and coefficient of correlation (R). Linear regression and coefficient of correlation between ichroma™ reader and ‘Access 2 were Y= 0.9837X + 0.0174 and R= 0.999 respectively Linear regression and coefficient of correlation between ichroma™ Il and Access 2 were Y= 0.98SX + 0.0644 and R = 0.998, 120 z y=0.9837« +0.0174 E 100 R= 0.999, 80 R=0.999 60 40 20 o E 0 2% 4 60 80 100 120 Access 2 [yl/emt] AL-GEO2-15 (Rex 04) Jeffcoate, S..: Clinic. In Endocrinol. Metab. 1975, 4:521. Cohen, XL: Metabolism, 1977, 26:1165, Pierce, J. G. Endocrinology. 1971, 89:1331-1344, Berger, S. and Quinn, J.L, Fund. Clin. Chem., N.W. Tieta(ed), W. 8. Saunders Co,, Phila, PA 14, 824-848( 1976), 7. Lundy, LE, Lee, G., Levy, W, et al. Obstet. Gynecol. 1974, 44:14 £8. Utiger,R.D., The Thyroid, S.C. Werner and S. Ingbar(eds.), Harper and Row, Hagerstown, MD, 1978, 9:196.208, 9, Clinical Guide to Laboratory Tests. Ed. NW. Tietz, 3" Ed, WA. Saunders Company, Philadelphia, PA 18106, 1995 arsRevision date: March 16,2021 (Rev03} Note: Please refer to the table below to identi various symbols Use bye aa a = A al eo) 4 @ «| Sieeaeae For technical assistance, please contact: Boditech Med Inc's Technical Services Tel +(82) 33 243-1400 E-mail: sales@[Link] Boditech Med Incorporated 43, Geodudanii 1g, Dongnae-mycon, CChuncheor-si, Gang-won-do, 24398 Republic of Korea Tel +(82)-33-243-1400 Fax: +(82) -33-243-9373, [Link] == obeliss.a Be. Général Wahis 53, 2030 Brussels, BELGIUM Tek: (32) -2-732-59-54 Fa (32) 2-732 60-09 E-Mail: mail@[Link] c€ iD AI-GEO2-1S (Rev 04) 5/5