TSH Product Insert
Contents
1. HAMA anti goat HAGA or anti rabbit HARA antibodies or those with Rheumatoid Factor RF may show falsely elevated or depressed values or may result in the error message Incomplete Test Patients routinely exposed to animals or animal serum products or with rheumatoid arthritis can be prone to these types of interferences If the TSH level is inconsistent with clinical evidence additional TSH or other thyroid testing is suggested to confirm the results HAMA has been shown to significantly interfere at concentrations gt 52 5 ng mL RF interference was detected above 53 8 IU mL Although hemolysis has an insignificant effect on the assay hemolyzed samples may indicate mistreatment of a specimen prior to assay and results should be interpreted with caution Lipemia has an insignificant effect on the assay except in the case of gross lipemia where interference with the lateral flow of the sample in the cartridge may occur Potential interference of the following drugs were tested at the indicated concentrations and showed no significant interference Acetaminophen 1 324 uM Diltiazem 15 0 uM Erythromycin 81 6 uM and Verapamil 4 4 uM However some medications may interfere with assay performance for a variety of reasons All results should be interpreted with respect to the clinical picture of the patient The concentration of TSH in a given sample determined with assays from different manufacturers can vary due to differen2. the cartridges needed for a particular run should be removed from the refrigerator and allowed to reach room temperature for 15 30 minutes before they are used Calibration The calibrators used during the reagent manufacture process to create the information placed electronically on the FREND TSH Code chip are prepared gravimetrically and are compared to international reference standards WHO International Thyroid Stimulating Hormone human for Immunoassay NIBSC code 81 565 However for the end user there is no need for calibration as is generally performed on other automated laboratory equipment All calibration statistics and information have been electronically stored on the FREND TSH Code chip included in each box of FREND TSH The FREND TSH Code chip is specific for that manufactured lot of FREND TSH cartridges The appropriateness of the calibration information should always be checked by running sufficient external quality control materials as samples to verify that the results obtained for TSH on the FREND System using the FREND TSH cartridges of a particular lot meet the laboratory criterion for acceptability FREND TSH Code chip installation Please refer to the FREND System user manual for more detailed instructions relative to the Code chip installation Abbreviated instructions follow here 1 Insert the FREND System electrical cord into an appropriate outlet 2 Insert the Code chip in
3. and high levels of T3 and or T4 Anomalies to these types classification exist but TSH testing can with the aid of other thyroid tests help a clinician determine the presence of thyroid dysfunction Principle of the assay The FREND TSH test cartridge is a rapid quantitative sandwich immunoassay utilizing fluorescent nanoparticles in microfluidic flow to capture and quantify TSH in serum and lithium heparin plasma TSH is a glycoprotein molecular weight approximately 28 000 daltons that is composed of alpha and beta subunits The alpha subunit is shared with other hormones and is a potential cause of cross reactivity human chorionic gonadotropin hCG follicle stimulating hormone FSH and luteinizing hormone LH The beta subunit is unique to each of these hormones and this beta subunit is targeted by capture antibodies in the FREND TSH A 35 uL drop of patient serum or lithium heparin plasma is placed in the FREND TSH cartridge inlet port where the sample interacts with a proprietary mix of dry loaded reagents One of these reagents includes antibody conjugated fluorescent nanoparticles forming immune complexes with TSH in the patient sample Capillary action moves the sample to the detection region where capture antibodies grab the TSH nanoparticle The concentration of TSH is calculated by the FREND System when the ratio of Test Reference fluorescence in an unknown is compared to that same ratio for stan
4. expelled and the results displayed JN Donot remove power from the FREND System while a cartridge is inthe reading chamber This may cause a system error 10 If the FREND System is connected to the optional printer press the Print button and the results will be output on the printer paper 11 For more detailed instructions please refer to the FREND System User Manual Procedural notes If a specimen Thyroid Stimulating Hormone TSH concentration is found to be greater than the linearity limit of the assay of 25 mIU L and a definitive result is required the specimen should be manually diluted with a serum plasma sample or serum plasma pool that has been previously measured on the FREND TSH and found to contain a TSH concentration of lt 0 06 mIU L and then re assayed according to the assay procedure The exact dilution will depend upon the original value but we suggest that one begin with a 1 5 and a 1 10 dilution If the result of the 1 10 dilution is still outside the linear limits a 1 20 and 1 50 dilution should be made and these dilutions re assayed It is desirable to dilute the sample so that the diluted sample reads between 2 and 20 mlU L Once a TSH result is obtained within the assay linearity the original concentration of the unknown can be easily manually calculated 10 Below is an example using a final diluted sample result of 12 6 mIU L a 1 20 dilution and a diluent sample concentration of 0 25 mlU L
5. 0 39 ug BioCheck Inc Foster City CA Cat 70204 BC 183 BioCheck Inc Foster City CA Cat 70342 G 7003 Materials required but not provided The following materials are not provided with the reagent but are required to perform TSH analysis using the FREND TSH cartridges on the FREND System They are available separately from NanoEnTek Materials Cat No FREND System F10 Micro pipette capable of delivering 35 uL External Source Warnings and precautions The FREND TSH cartridges are intended for in vitro diagnostic use only TSH cartridges are only to be used on the NanoEnTek FREND System Allow cartridges to come to room temperature for 15 30 minutes prior to use Assure the humidity is within the specifications listed in the FREND System User Manual 10 80 Assure the room temperature remains in the range of 22 30 C when tests are run Avoid cross contamination between samples by using a new pipette tip for each new specimen Avoid high humidity direct sunlight or heat in the area used for cartridge storage Inaccurate results are possible if the sample used is contaminated in any way Using specimens containing clotted fibrin could result in erroneous results Over or under loading the cartridge with sample may result in inaccurate results Cartridges should not be frozen Human specimens are not used in the preparation of this product however since human specimens will be used for sam
6. 7 15 180 15 418 70 18 72 17 43 17 63 17 927 17 959 80 21 88 20 09 20 37 20 780 20 500 90 22 38 23 37 23 68 23 143 23 041 100 25 91 25 32 25 40 25 543 25 582 Comparative analysis In a clinical study 438 serum samples obtained from subjects both apparently normal and with thyroid conditions as well as other undisclosed diseases and conditions and stored at 70 C under monitored conditions for less than one year were analyzed using both the FREND TSH and another commercially available TSH fluorescent immunoassay Results generated using the FREND TSH on the FREND System y were compared to those obtained using a previously FDA cleared TSH assay x Results of this study are shown below with a measuring range of 0 09 24 96 mlU L 30 00 y 0 9509x 0 0267 25 00 R 0 9849 20 00 15 00 FREND TSH mlU L 10 00 5 00 0 00 0 00 5 00 10 00 15 00 20 00 25 00 30 00 Predicate device mIU L Comparability using CLSI guideline EPO9 A2 IR Section 7 shows that the difference in concentration between what was measured and what was expected is acceptable and that the two methods compare favorably 16 Precision Precision testing single lot and single site Precision was determined as described in the CLSI protocol EP05 A2 Four clinical samples were assayed in replicates of two at two separate times per day for twenty days using a single lot of FREND TSH cartridge The findings follow showing repea
7. NESPI FRTS OO1EN V 1 0 Nano ntTek CE FREND TSH Thyroid Stimulating Hormone Intended use FREND TSH is designed for in vitro DIAGNOSTIC USE ONLY for the quantitative measurement of Thyroid Stimulating Hormone thyrotropin or TSH in human serum and lithium heparin plasma using the FREND System FREND TSH is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in the diagnosis of thyroid disease Summary and explanation of test Human Thyroid Stimulating Hormone hTSH or thyrotropin stimulates the secretion of thyroxine T4 and triiodothyronine T3 by the thyroid gland T3 and T4 are known to have diverse functions in regulating basal metabolic rate bone growth neuronal development and sex maturation Underproduction of T3 and or T4 can result in hypothyroidism while overproduction of these hormones can result in hyperthyroidism Because of a negative feedback mechanism elevation of T3 and T4 suppress the production of TSH TSH itself is stimulated by thyrotropin releasing hormone TRH a tri peptide produced in the hypothalamus Primary hypothyroidism occurs when TSH levels are elevated while T3 and or T4 are under produced Secondary or tertiary hypothyroidism can occur with abnormal response of TSH to TRH while central hypothyroidism occurs from pituitary dysfunction Primary hyperthyroidism is marked by low levels of TSH
8. Stimulating Hormone TSH concentration in mIU L based upon information stored on the TSH Code chip This result is then output on the screen and to the optional printer It is also stored in memory on the FREND System 11 Screen displays for various concentration scenarios Displayed result Description Date Time 2014 2 19 10 15 Patient ID KIM 04 User ID LEE 01 TSH concentration Order 765 Lab ID NANOENTEK Less than 0 06 mIU L IU mL TSH lt 0 06 mlU L Date Time 2014 2 19 10 15 Patient ID KIM 04 TSH concentration User ID LEE 01 Not less than 0 06 mIU L ulU mL Order 765 Lab ID NANOENTEK And not higher than 25 00 mlU L IU mL TSH 0 95 mlU L ulU mL Date Time 2014 2 19 10 15 Patient ID KIM 04 User ID LEE 01 Order 765 Lab ID NANOENTEK Higher than 25 00 mlU L ylU mL TSH concentration TSH gt 25 00 mlU L Limitations of the procedure When used for diagnostic purposes the results obtained from this assay should be used in conjunction with other data e g symptoms results of other tests clinical impressions medical history therapy etc The FREND System paired with a FREND TSH cartridge is programmed to report 25 0 mlU L as the highest concentration of TSH measurable without dilution The lowest measurable concentration is 0 06 mlU L the assay sensitivity limit Specimens from patients with heterophilic antibodies such as anti mouse
9. al utility of a sensitivity and reliable radioimmunoassay of Thyroid Stimulating Hormone Southern Medical Journal 1983 76 969 976 7 Burger H G Patel Y C The value of serum thyrotrophin measurement in the diagnosis and management of hypothyroidism Med J Aust 1972 2 293 297 8 Petersen V B McGregor A M Belchetz P E Elkeles R S Hall R The secretion of thyrotrophin with impaired biological activity in patients with hypothalamic pituitary disease Clinical Endocrinology 1978 8 397 402 9 Beck Peccoz P Amr S Menezes Ferreira M M Faglia G Weintraub B D Decreased receptor binding of biologically inactive tyhyrotrophin in central hypothyroidism New England Journal of Medicine 1985 312 1085 1090 21 10 Hay I D Bayer M F Kaplan M M Klee G G Larson P R Spencer C A American Thyroid Association Assessment of current free thyroid hormone and thyrotrophin measurements and guidelines for future clinical assays Clinical Chemistry 1991 37 2002 2008 11 Demers L M Spencer C A Laboratory medicine practice guidelines Laboratory support for the diagnosis and monitoring of thyroid disease The National Academy of Clinical Biochemistry 1996 12 Beastall G H Beckett G J Franklyn J Frasier W D Kichey J John R Kendall0Taylor P Nevens B Vanderpump M UK Guidelines for the use of thyroid function tests The association for Clinical Biochemistry 2006 13 Schr
10. ces in assay methods calibration and antibody specificity Please refer to the specimen collection and handling warnings and precautions storage and stability and procedural Notes sections in this insert sheet FREND TSH has not been validated in point of care settings Performance of this assay has not been established with neonatal specimens or specimens from pregnant women FREND TSH is to be used in licensed clinical laboratories with trained technologists Expected values As with every clinical diagnostic test a reference interval corresponding to the characteristics of the population being tested should be determined by each laboratory Historically It has been shown that there are neither racial differences nor gender differences in the reference interval for TSH so creating a single adult reference interval is reasonable and justified During a clinical study performed to support the FREND TSH substantial equivalence to a marketed product with the same indication TSH measurements were determined on the serum of 385 apparently healthy ambulatory adults 195 males and 190 females ages 18 71 who stated they had no known thyroid conditions All samples were assayed in singlicate on the FREND TSH and the predicate device A single value determined as an outlier in both the test and the predicate devices was removed from the data set after which a non parametric reference interval encompassing the central 95 of th
11. dards of known concentration The result is calculated using information stored on the lot specific FREND TSH Code chip and then is displayed on the FREND System screen A hard copy printout can be obtained if desired A ratio calculated between the Reference zone and the Test zone corrects for test to test variations Total TSH concentration in a sample analyzed with the FREND TSH on the FREND System correlates directly with the fluorescence intensity the higher the TSH concentration the greater the fluorescence ratio The FREND TSH has a measuring range determined as 0 06 mlU L or pIU mL to 25 0 mIU L The FREND TSH uses single use transparent plastic cartridges in which all required reagents are stored within the cartridge itself All that is added by the user is a 35 uL test sample The cartridge is inserted into the FREND System in a prescribed fashion indicated with a black arrow on the cartridge The reaction is read multiple times as the sample moves via capillary action through the cartridge This type of assay system is sometimes referred to as one which incorporates laminar flow Material provided FREND TSH Catalog number FRTS 025 FREND TSH cartridges 25 Disposable pipette tips 30 FREND TSH Code chip 1 FREND TSH package insert 1 One cartridge contains Mouse Monoclonal anti Human Beta TSH 450 45ng Goat Polyclonal anti Human Beta TSH 48 48ng Fluorescent particles 3 96
12. e interpretation of a TSH result as assayed on the FREND TSH Interference Study Results for FREND TSH on the FREND System Tested drug Concentration tested uM Acetaminophen 1 324 0 Diltiazem 15 0 Erythromycin 81 6 Verapamil 44 Matrix study Forty 40 serum lithium heparin plasma sample pairs collected at the same time from a variety of patients were tested using the FREND TSH over a period of five different days with three different lots of FREND TSH reagent Results covered the reporting range of the assay Linear regression analysis x serum y lithium heparin plasma was performed with the following results n 40 slope 0 995 y intercept 0 32 r 0 992 rP 0 985 20 References 1 Pierce J G The subunits of pituitary thyrotrophin their relationship to other glycoprotein hormones Journal of Endocrinology 1971 89 1331 1344 2 Smith B R Pyle G A Peterson V B Hall R Interaction of thyrotrophin with the human thyrotrophin receptor Journal of Endocrinology 1977 75 391 400 3 Sterling K Lazarus J H The thyroid and its control Ann Rev Physiol 1977 39 349 371 4 Patel Y C Alford F P Burger H G The 24 hour plasma thyrotrophin profile Clinical Science 1972 43 71 77 5 Morley J E Neuroendorine control of thyrotrophin secretion Endocrine Review 1981 2 396 436 6 Wehmann R E Rubenstein H A Pugeat M M Nisula B C Extended clinic
13. e results was determined There was no significant difference in TSH reference interval between adult males and adult females Adult reference interval was calculated to be 0 49 3 82 mIU L 14 As in all in vitro diagnostic testing a TSH result generated using the FREND TSH on the FREND System should be interpreted in the light of other clinical findings and diagnostic procedures Any TSH results not correlating with the clinical condition should be repeated and other testing performed to clarify the situation Performance characteristics Performance characteristics were evaluated for the FREND TSH as follows Accuracy Dilution linearity Specimens from a high TSH concentration pool were diluted with a low TSH concentration pool following instructions in the CLSI EPO6 A document Linearity was demonstrated from lt 0 06 mlU L to 25 54 mlU L Correlation with the expected values was excellent showing less than the allowable non linearity slope 0 977 y intercept 0 17 Performance requirement was verified over the measurement interval per CLSI recommendations FREND TSH is linear from 0 06 25 0 mIU L FREND TSH Linearity Level Rep 1 Rep 2 Rep 3 Mean Linear Fit 0 0 01 0 01 0 03 0 017 0 173 10 2 85 2 78 2 78 2 803 2 714 20 5 61 5 37 5 47 5 483 5 255 30 8 47 7 80 8 53 8 267 7 796 40 9 60 9 43 10 62 9 883 10 337 50 12 20 13 17 12 51 12 627 12 878 60 15 63 15 64 14 2
14. iration date is clearly indicated on the product box and the cartridges Materials Cat No Refrigerator temperature 2 8 C TSH cartridges FRTS 025 Room temperature 18 25 C Pipette Tips None Specimen collection and handling Serum or lithium heparinized plasma is required for the assay No special patient preparation is necessary To use serum a blood sample is collected aseptically without additives by venous puncture After allowing the sample to clot for 30 minutes at room temperature the collection tube should be centrifuged for 10 minutes at 3 000 rpm For lithium heparinized plasma a venous blood sample is collected aseptically with the designated additive The plasma should be separated from the packed cells as soon as possible Samples may be stored at 2 8 C for up to 6 hours prior to analysis If the analysis is scheduled to be done at some later time the sample should be stored frozen at 20 C or below for future use Repeated freeze thaw cycles should be avoided Turbid serum samples or samples containing particulate matter such as fibrin clots or strands should be centrifuged before being tested Prior to assay slowly bring frozen samples to room temperature 18 25 C and mix gently but thoroughly before testing The sample required is 35 uL Procedure Reagent preparation There is no reagent preparation required to measure TSH using the FREND TSH cartridge on the FREND System However
15. minutes prior to the start of the testing sequence For consistent results all testing should be done when room temperature is 22 30 C If using refrigerated patient samples remove those from the refrigerator and allow to them to come to room temperature prior to testing If frozen samples will be utilized be sure these are removed from the freezer thawed naturally and then mixed gently but thoroughly prior to testing Testing should not begin on these previously frozen samples until they have reached room temperature There are no other reagents or sample preparations necessary Assay procedure 1 Prepare the FREND TSH cartridge and specimen 2 Record the Sample ID on the cartridge in the designated area 3 Drop the sample 35 uL into the sample inlet on the cartridge using a suitable micro pipette equipped with a fresh pipette tip 4 Press the Test button on the Main screen of the FREND System 5 The system moves to the Patient ID screen automatically 6 Type the Patient ID and press the Enter button to begin the test 7 Insert the cartridge into the cartridge slot using the cartridge arrows as a guide A Please check the direction of the cartridge before insertion and assure the insertion is complete 8 When the reaction in the cartridge is complete the FREND System will automatically begin the reading process 9 When the measurements are completed the cartridge will automatically be
16. ms storage operator or other are identified 6 Or other times as required by your laboratory s standard QC procedures Individual laboratory policy will dictate exactly which control materials and lot numbers should be run the frequency with which controls are to be tested criteria for acceptance of the results and required corrective action to be taken if results do not meet laboratory criteria If any external quality control sample values are out of the acceptable range it will be necessary to investigate the problem before reporting patient results to assure there is not an instrument or software malfunction Do not assay patient samples on the FREND System using the FREND TSH if quality control results do not give expected values Refer to your laboratory policies on how to determine acceptability of external control material results Each laboratory operates under a different set of regulations Every laboratory must follow the standardized procedures acceptable to the regulatory agencies to which the laboratory is responsible In the United States please comply with all federal state and local regulations regarding the frequency and extent of external quality control testing Specimen processing Preparation Remove from the refrigerator sufficient cartridges of FREND TSH to test the number of patient samples and required external quality control materials Allow the cartridges to come to room temperature for 15 30
17. off R W Foon K A Beatty S M Oldham R K Morgan A C Human Anti Murine ImmunoglobulinResponses in Patients Receiving Monoclonal Antibody Therapy Cancer Research 1985 879 885 14 Boscato L M Stuart M C Heterophilic Antibodies A Problem for All Immunoassays Clinical Chemistry 1988 27 22 Glossary of symbols Do not reuse 2 Use by YYYY MM DD Exp Date OMM DD Lot number Catalog number Warning or Caution Manufactured by Authorized representative in the Europe Community Invitro diagnostic medical device Temperature limitation Contains sufficient for lt n gt tests IE AAEE 23 Nano nfek www henryschein com requestinfo www henryschein com frend ed Manufactured by NanoEnTek Inc HQ 12F 5 Digital ro 26 gil Guro gu Seoul 152 740 Korea Tel 82 2 6220 7940 Fax 82 2 6220 7721 US Branch NanoEnTek USA Inc 5627 Stoneridge Drive Suite 304 Pleasanton CA 94588 USA Tel 1 925 225 0108 1 888 988 0108 Toll free Fax 1 925 225 0109 EC REP MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St Ingbert Germany SK Medical Beijing Co Ltd 26F SK tower No 6 Jia Jianguomenwai Avenue Chaoyang District Beijing 100022 P R China Tel 86 10 5920 7844 Fax 86 10 5920 5697 Revised on 2014 03 14
18. ples and other quality control products in the lab may be derived from human materials please use standard laboratory safety procedures when handling all specimens and controls Do not use the cartridges beyond the expiration date on the pouch Do not use the cartridge if the pouch is damaged or the seal is broken Perform testing as specified in the Package Insert and User Manual TSH cartridges are disposable single use devices Do not reuse them under any circumstances Keep the cartridge sealed in the pouch until just ready for use Use the cartridge immediately after opening its pouch Wear disposable gloves when handling the cartridges and the samples Wash hands thoroughly and often after handling reagent cartridges or samples Do not use the silica gel pouch in the cartridge for human consumption TSH has been designed so that the high dose hook effect is not a problem for the vast majority of samples Samples with TSH concentrations between 25 and 2 500 mlU L will read gt 25 mlU L The hook effect phenomenon may occur only at TSH concentrations gt 2 500 mlU L Values this high are not seen clinically Handle specimens in accordance with the OSHA Standard on Bloodborne Pathogens Storage and stability All unopened materials are stable until the expiration date on the label when stored at the specified temperature Cartridge stability has been demonstrated for twelve months from the date of manufacture The exp
19. tability between run between day and within laboratory precision data Sample MeanTSH Repeatability Between run Between day oor miu sD evea so eves so Jove sD Ilove 1 0496 0043 86 0012 24 oo17 34 0047 96 2 5948 0353 59 0082 14 0031 05 0364 61 3 11989 0555 46 0375 3 1 o1se 13 loess 57 4 23763 0846 36 0478 20 o000 00 0972 41 Specificity The a subunits of luteinizing hormone LH follicle stimulating hormone FSH human chorionic gonadotropin hCG and thyroid stimulating hormone TSH are all very similar though their B subunits are not Because of the structural similarities the specificity of the FREND TSH must be examined in the presence of large amounts of these possible cross reactants The following substances were evaluated for potential cross reactivity with the FREND TSH at the concentrations indicated below Testing was done according to the instructions recommended in CLSI protocol EP07 A No significant cross reactivity was found 17 Specificity of FREND TSH pape ter Interferent Material added fe ross Cone mIU L Reactivity 0 49 hCG 200 000 mIU mL 2x 10 0 55 LH 500 mIU mL 2x 10 0 55 FSH 500 mIU mL 5 x 10 6 22 hCG 200 000 mIU mL 3x 107 6 06 LH 500 mIU mL 3x 10 6 06 FSH 500 mIU mL 1x 10 Analytical sensitivity The Limit of Detection LoD for the FREND TSH
20. to the Code chip slot at the rear of the FREND System following the arrows 3 Press the Setup button on the Main screen 4 Press the Code chip button on the Setup screen 5 The information embedded on the FREND TSH Code chip is automatically saved on the FREND System 6 When the Code chip installation is completed press the OK button to go to the Setup screen 7 Press the Item button on the Setup screen 8 Check the FREND TSH cartridge lot number and the installation date of the Code chip 9 Press the Home button to go to the Main screen to begin running external quality control and patient samples Quality control FREND System QC cartridge FREND QC Cartridge contains multiple controls to check optic part of the system By testing QC Cartridge part of analytical components of the system of 1 laser power 2 alignment and 3 mechanical integrity are confirmed For each day of patient testing perform QC Cartridge testing Refer to the quality control procedures section in the User Manual of FREND System In brief perform QC cartridge testing for the following conditions 1 Upon initial setup of the system 2 Each day of patient testing 3 When the system has been transported or moved 4 Whenever there is uncertainty about the performance of the system 5 Whenever required by your laboratory s quality control requiremen
21. ts Internal procedural controls FREND TSH test cartridge contains built in control features Fluorescence signal in the reference zone of each cartridge shows 1 that enough volume is added 2 that proper flow is obtained and 3 that the antibody is reactive If this reference zone signal is missing or lower than threshold the FREND System consider it as an incorrect or failed test not producing a test result but an error message In addition with each cartridge run the system monitors in part for 1 flow of sample 2 speed of sample flow 3 shelf life of cartridge components 4 function of internal barcode scanner and 5 function of scanner s mechanical components External quality control testing Commercially available controls from a variety of manufacturers are available that contain TSH as a measured analyte It is recommended that a minimum of at least two 2 levels of controls be run at least once per month or once for each new lot whichever comes earlier However Controls should be run with a minimum frequency depending on number of tests run in the laboratory Each laboratory should establish its own criteria based on the following parameters 1 Each new lot 2 Each new shipment even if from the same lot previously received 3 Each new operator an individual who has not run the tests for at least two weeks 4 Monthly as a continued check on storage conditions 5 Whenever proble
22. was determined using the CLSI EP17 A protocol The analytical sensitivity of the FREND TSH was determined to be 0 06 mIU L Interference Interference is defined for purposes of this claim to be recovery outside 10 of the known mean concentration In other words recovery from 90 to 110 of the expected is considered acceptable performance in interference studies as listed below Endogenous interferents These interference studies on endogenous substances were performed using the FREND TSH on the FREND System according to the recommendations in the CLSI protocol EP07 A 18 Added hemoglobin up to 500 mg dL does not interfere with the assay Average recovery when added to serum containing TSH at 0 3 and 8 mIU L was 98 8 Added conjugated bilirubin up to 20 mg dL does not interfere with the assay Average recovery when added to serum containing TSH at 0 3 and 8 mlU L was 100 0 Added total protein up to 12 0 g dL does not interfere with the assay Average recovery when added to serum containing TSH at 0 3 and 8 mlU L was 100 4 Added triglyceride up to 3 g dL does not interfere with this assay Average recovery when added to serum containing TSH at 0 3 and 8 mlU L was 101 6 19 Pharmaceutical interferents A variety of common medications were tested for interference with the FREND TSH The testing showed there was no significant interference lt 10 from the tested drugs that would affect th
23. where X equals the original concentration of the unknown sample and indicates multiplication 1 X mIU L 19 0 25 mIU L 12 6 mlU L 20 12 6 mlU L X mlU L 4 75 mIU L 20 20 12 6 mIU L X mlU L 4 75 252 0 mlU L X mlU L 4 75 mIU L 252 0 mIU L 4 75 mlU L X mIU L 247 25 mlU L XmlU L Original unknown concentration of TSH equals 247 25 mIU L To use this formula to calculate the original concentration of any unknown sample TSH which exceeds the assay linearity and is diluted with another sample previously measured with the FREND TSH just substitute the appropriate measured result on the diluted sample the dilution factor and the diluent TSH concentration for those used above in the example To do a quick check on your result the original concentration for the unknown should always be just slightly less than the diluted result multiplied by the dilution factor without taking into consideration the TSH value of the sample used as the diluent Calculation of results The FREND System performs all sample and reagent handling operations automatically within the cartridge once the sample has been manually loaded to the sample inlet in the cartridge and the cartridge placed into the FREND System The rate of fluorescence produced by the reaction is read at various intervals during the analysis process blank readings are subtracted after which the net rate is automatically converted to Thyroid
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