INSTRUCTIONS FOR USE
VITROS Immunodiagnostic Products TSH Reagent Pack VITROS Immunodiagnostic Products TSH Calibrators Intended Use
For in vitro diagnostic use only.
TSH
191 2997 148 7289
VITROS Immunodiagnostic Products TSH Reagent Pack
For the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
VITROS Immunodiagnostic Products TSH Calibrators
For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin).
Summary and Explanation of the Test
TSH secretion by the anterior pituitary is controlled by thyrotropin releasing hormone, a tripeptide produced by the hypothalamus. TSH stimulates the production of thyroxine (T4) and triiodothyronine (T3) by the thyroid gland. The circulating free fractions of T4 and T3 in turn regulate the secretion of TSH by a negative feedback mechanism at the pituitary and possibly the hypothalamus.1 The diagnosis of overt hypothyroidism by the finding of a low total T4 or free T4 concentration is readily confirmed by a raised TSH concentration.2 Measurement of low or undetectable TSH concentrations may assist the diagnosis of hyperthyroidism,3, 4 where concentrations of T4 and T3 are elevated and TSH secretion is suppressed. TSH tests with high levels of precision and functional sensitivity claims of 0.010.02 mIU/L have been termed third generation tests.5 These have the advantage of discriminating between the concentrations of TSH observed in thyrotoxicosis, compared with the low, but detectable, concentrations that occur in subclinical hyperthyroidism.6
Principles of the Procedure
The VITROS TSH test is performed using the VITROS TSH Reagent Pack and the VITROS TSH Calibrators on the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System using Intellicheck Technology. An immunometric immunoassay technique is used, which involves the simultaneous reaction of TSH present in the sample with a biotinylated antibody (mouse monoclonal anti-whole TSH) and a horseradish peroxidase (HRP)labeled antibody conjugate (mouse monoclonal anti-TSH -subunit). The antigen-antibody complex is captured by streptavidin on the wells. Unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction.7 A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is directly proportional to the concentration of TSH present. Time to first result 37 minutes Test Temperature 37 C Reaction Sample Volume 80 L
Test Type Immunometric
System* ECi/ECiQ, 3600, 5600
Incubation Time 29 minutes
* Not all products and systems are available in all countries.
Version 5.0
Pub. No. GEM1001_EN_WW
TSH
Reaction Scheme
INSTRUCTIONS FOR USE
Warnings and Precautions
Warnings and Precautions
WARNING: Potentially Infectious Material Use caution when handling material of human origin. Consider all samples potentially infectious. No test method can offer complete assurance that hepatitis B virus, hepatitis C virus (HCV), human immunodeficiency virus (HIV 1+2) or other infectious agents are absent. Handle, use, store and dispose of solid and liquid waste from samples and test components, in accordance with procedures defined by appropriate national biohazard safety guideline or regulation (e.g. CLSI document M29). 8
WARNING:
Contains Kathon (CAS 55965-84-9) The VITROS TSH Reagent Pack contains Kathon. R43: May cause sensitization by skin contact. S24: Avoid contact with skin. S37: Wear suitable gloves.
Reagents
Reagent Pack Contents
1 reagent pack containing: 100 coated wells (streptavidin, binds 3 ng biotin/well) 6.2 mL conjugate reagent (HRP-mouse monoclonal anti-TSH subunit, binds 608.4 IU TSH/mL) in buffer with bovine gamma globulin, bovine serum albumin and antimicrobial agent 9.1 mL biotinylated antibody reagent (biotin-mouse monoclonal anti-TSH, binds 202.8 IU TSH/mL) in buffer with bovine gamma globulin, bovine serum albumin and antimicrobial agent
Reagent Pack Handling
The reagent pack is supplied ready for use. The reagent pack contains homogeneous liquid reagents that do not require shaking or mixing prior to loading on the system. As with all immunoassay protein-based solutions, inappropriate handling of the reagent pack can cause foam to occur on the surface of the reagent. Avoid agitation, which may cause foaming or the formation of bubbles. If reagent packs are dropped or agitated, small levels of fine foam could be generated that may not be detected by the system. Reagent packs containing fine foam that is not detected by the system, may show a negative bias. If you must use a dropped or agitated reagent pack before it has been allowed to settle, you should verify performance by running high and low quality control samples in duplicate after loading the pack on the system.
Reagent Pack Storage and Preparation
Reagent Unopened Opened Opened Storage Condition Refrigerated 28 C (3646 F) On system System turned on Refrigerated 28 C (3646 F) Stability expiration date 8 weeks 8 weeks
The VITROS TSH Reagent Pack is suitable for use until the expiration date on the carton when stored and handled as specified. Do not use beyond the expiration date. Pub. No. GEM1001_EN_WW Version 5.0
INSTRUCTIONS FOR USE
Specimen Collection, Preparation and Storage
Do not freeze unopened reagent packs. Load reagent packs directly from refrigerated storage to minimize condensation. Store opened refrigerated reagent packs in a sealed reagent pack storage box that contains dry desiccant.
TSH
Calibrator Contents
1 set of VITROS TSH Calibrators 1, 2 and 3 (recombinant TSH in bovine serum with antimicrobial agent, 2.3 mL); nominal values 0; 0.092 and 15.9 mIU/L (IU/mL) (2nd IRP 80/558) Lot calibration card Protocol card 24 calibrator bar code labels (8 for each calibrator)
Calibrator Handling
Use only with reagent packs of the same lot number. Mix thoroughly by inversion and bring to 1530 C (5986 F) before use. Each pack contains sufficient for a minimum of 6 determinations of each calibrator. Handle calibrators in stoppered containers to avoid contamination and evaporation. To avoid evaporation, limit the amount of time calibrators are on the system. Refer to the operating instructions for your system. Return to 28 C (3646 F) as soon as possible after use, or load only sufficient for a single determination.
Calibrator Storage and Preparation
Calibrator Unopened Opened Opened Storage Condition Refrigerated 28 C (3646 F) Refrigerated 28 C (3646 F) Frozen -20 C (-4 F) Stability expiration date 13 weeks 13 weeks
VITROS TSH Calibrators are supplied ready for use. VITROS TSH Calibrators are suitable for use until the expiration date on the carton when they are stored and handled as specified. Do not use beyond the expiration date. Opened calibrators may be stored frozen (with no more than 1 freeze-thaw cycle). The VITROS TSH test uses 80 L of calibrator for each determination. The VITROS TSH Calibrators may be used directly on the VITROS Immunodiagnostic and VITROS Integrated Systems. Alternatively, transfer an aliquot of each calibrator into a sample container (taking account of the minimum fill volume of the container), which may be bar coded with the labels provided. For details on minimum fill volume of sample cups or containers, refer to the operating instructions for your system.
Specimen Collection, Preparation and Storage
Patient Preparation
No special patient preparation is necessary.
Specimens Recommended
Serum Heparin plasma EDTA plasma
Specimens Not Recommended
Do not use turbid specimens. Turbidity in specimens may affect test results.
Special Precautions
Important: Certain collection devices have been reported to affect other analytes and tests.9 Owing to the variety of specimen collection devices available, Ortho-Clinical Diagnostics is unable to provide a definitive statement on the performance of its products with these devices. Confirm that your collection devices are compatible with this test.
Version 5.0
Pub. No. GEM1001_EN_WW
TSH
Specimen Collection and Preparation
INSTRUCTIONS FOR USE
Testing Procedure
Collect specimens using standard procedures.10,11 Samples should be thoroughly separated from all cellular material. Failure to do so may lead to an erroneous result. Thoroughly mix samples by inversion and bring to 1530 C (5986 F) before use. The VITROS TSH test uses 80 L of sample for each determination. This does not take account of the minimum fill volume of the chosen sample container. For details on minimum fill volume of sample cups or containers, refer to the operating instructions for your system.
Handling and Storage Conditions
Handle samples in stoppered containers to avoid contamination and evaporation. The amount of time samples are on the system prior to analysis should be limited to avoid evaporation. Refer to the operating instructions for your system. Return to 28 C (3646 F) as soon as possible after use, or load sufficient for a single determination. Serum and plasma samples may be stored for up to 7 days at 28 C (3646 F) or 4 weeks at -20 C (-4 F). Avoid repeated freeze-thaw cycles.
Testing Procedure
Materials Provided
VITROS Immunodiagnostic Products TSH Reagent Pack VITROS Immunodiagnostic Products TSH Calibrators VITROS Immunodiagnostic Products Signal Reagent VITROS Immunodiagnostic Products Universal Wash Reagent VITROS Immunodiagnostic Products High Sample Diluent A Quality control materials such as VITROS Immunodiagnostic Products Total Thyroid Controls or VITROS Immunodiagnostic Products Free Thyroid Controls VITROS Immunodiagnostic Products Reagent Pack Storage Box (optional) with desiccant
Materials Required but not Provided
Operating Instructions
Check the inventory regularly to aid the management of reagents and ensure that sufficient VITROS Signal Reagent, VITROS Universal Wash Reagent and calibrated reagent lots are available for the work planned. When performing panels of tests on a single sample, ensure that the sample volume is sufficient for the tests ordered. For detailed information refer to the operating instructions for your system. NOTE: Do not use visibly damaged product.
Sample Dilution
Serum or plasma (EDTA or heparin) samples with concentrations greater than the measuring range may be automatically diluted on the system up to 10-fold (1 part sample with 9 parts diluent) by the VITROS Immunodiagnostic and VITROS Integrated Systems with the VITROS High Sample Diluent A Reagent Pack prior to test. Refer to the High Sample Diluent A Reagent Pack instructions for use.
Default Test Name
The default test name which will appear on patient reports is TSH. The default short name that will appear on the test selection menus and laboratory reports is TSH. These defaults may be reconfigured, if required. For detailed information refer to the operating instructions for your system.
Calibration
Calibration Procedure
Calibration is lot specific; reagent packs and calibrators are linked by lot number. Reagent packs from the same lot may use the same calibration. A Master Calibration (a dose response curve covering the full calibration range) is established for each new reagent lot. Concentrations for the linked lot of calibrators are determined from the Master Calibration. Ensure that the Master Calibration for each new reagent lot is available on your system. Process calibrators in the same manner as samples. Calibration need not be programmed if bar code labels are used; load the calibrators in any order, calibration will be initiated automatically.
Pub. No. GEM1001_EN_WW
Version 5.0
INSTRUCTIONS FOR USE
Quality Control
TSH
When the calibrators are processed the signal expected for each calibrator is compared against the actual signal obtained. The Master Calibration is then rescaled to reflect the differences between the actual and expected signals. The validity of this calibration curve is assessed against a range of quality parameters, and if acceptable, it is stored for use with any reagent pack of that lot. The quality of calibration cannot be completely described by a single parameter. The calibration report should be used in conjunction with acceptable control values to determine the validity of the calibration. Recalibration is required after a pre-determined calibration interval, or when a different reagent lot is loaded. Calibration results are assessed against a range of quality parameters. Failure to meet any of the defined quality parameter ranges will be coded in the calibration report. For actions to be taken following a failed calibration refer to the operating instructions for your system. Refer to the operating instructions for your system for detailed instructions on the calibration process.
When to Calibrate
Calibrate when the reagent pack and calibrator lot changes. Calibrate every 28 days. After specified service procedures have been performed. If quality control results are consistently outside of your acceptable range. For additional information on when to calibrate, refer to the operating instructions for your system.
Traceability of Calibration
Calibration of the VITROS TSH test is traceable to in-house reference calibrators, which have been value assigned to correlate to another commercially available test, with reference to the 2nd International Reference Preparation 80/558.
Calibration Model
A modified four-parameter logistic curve fit function is used to construct the Master Calibration. The calibration process rescales the Master Calibration to establish a valid stored curve for the VITROS Immunodiagnostic System and VITROS Integrated Systems.
Measuring (Reportable) Range
System 3600 5600 ECi/ECiQ (Lot 2850 and above) ECi/ECiQ (Lot 2849 and below) Measuring (Reportable) Range 0.015*100 mIU/L (IU/mL) 0**100 mIU/L (IU/mL)
* Lower limit of measuring range reported by the system software is based on the functional sensitivity. ** Lower limit reported by the system software is 0 mIU/L (IU/mL).
The lower limit reported by the system can be reconfigured if desired. For details on how to reconfigure the lower limit refer to the operating instructions for your system.
Quality Control
Quality Control Material Selection
VITROS Total Thyroid Controls or VITROS Free Thyroid Controls are recommended for use with the VITROS Immunodiagnostic and VITROS Integrated Systems. VITROS Total Thyroid Controls and VITROS Free Thyroid Controls contain 3 levels of TSH (low, medium and high). The performance of other commercial control fluids should be evaluated for compatibility with this test before they are used for quality control. Control materials may show a difference when compared with other TSH methods if they contain high concentrations of preservatives, stabilizers, or other nonphysiological additives, or otherwise depart from a true sample matrix. Appropriate quality control value ranges must be established for all quality control materials used with the VITROS TSH test.
Quality Control Procedure Recommendations
Good laboratory practice requires that controls be processed to verify the performance of the test. Choose control levels that check the clinically relevant concentrations. To verify system performance, analyze control materials: After calibration According to local regulations or at least once each day that the test is being performed After specified service procedures are performed If quality control procedures within your laboratory require more frequent use of controls, follow those procedures. Analyze quality control materials in the same manner as patient specimens. Pub. No. GEM1001_EN_WW 5
Version 5.0
TSH
INSTRUCTIONS FOR USE
Results
If control results fall outside your acceptable range, investigate the cause before deciding whether to report patient results. Refer to published guidelines for general quality control recommendations.12 For more detailed information, refer to the operating instructions for your system.
Quality Control Material Preparation and Storage
Refer to the manufacturers product literature for preparation, storage, and stability information.
Results
Results are automatically calculated by the VITROS Immunodiagnostic and VITROS Integrated Systems.
Reporting Units and Unit Conversion
Analyte results are quoted in units of mIU/L or IU/mL. To configure the units, refer to the operating instructions for your system. Conventional mIU/L (IU/mL 1) Alternate IU/mL (mIU/L 1)
Limitations of the Procedure
Known Interferences
The VITROS TSH test was evaluated for interference consistent with CLSI document EP7.13 Commonly encountered substances were tested on 2 lots of reagents. Of the compounds tested, none was found to cause a bias of >10%. Refer to Specificity for a list of compounds tested that did not show interference.
Other Limitations
The results from this or any other diagnostic test should be used and interpreted only in the context of the overall clinical picture. Biotin levels in serum remain elevated for up to 24 hours after oral or intravenous biotin administration.14 Heterophilic antibodies in serum or plasma samples may cause interference in immunoassays.15 These antibodies may be present in blood samples from individuals regularly exposed to animals or who have been treated with animal serum products. Results which are inconsistent with clinical observations indicate the need for additional testing. Certain drugs and clinical conditions are known to alter TSH concentrations in vivo. For additional information, refer to one of the published summaries.16,17,18 Thyroid hormone autoantibodies in samples may cause interference with this test.19 Results which are inconsistent with clinical observations indicate the need for additional testing. The performance of this test has not been established using neonatal specimens. The VITROS TSH Test has no high dose hook effect up to 5000 mIU/L (IU/mL). Do not use quality control materials preserved with azide.
Expected Values and Interpretation of Results
It is recommended that each laboratory establish its own expected values for the population it serves.
Euthyroid Reference Interval
Units = mIU/L (IU/mL) 0.4654.68 Mean: 1.48 This reference interval is the central 95% of results of a study of 525 patients of euthyroid status who were not on thyroid treatment. Of 114 hypothyroid patients tested, all had concentrations >4.68 mIU/L (IU/mL). Of 100 hyperthyroid patients tested, all had TSH concentrations <0.465 mIU/L (IU/mL).
Interpretation of Results
For patient sample values outside your established reference interval, the system may be configured to display a flag LO or HI. For detailed information refer to the operating instructions for your system.
Pub. No. GEM1001_EN_WW
Version 5.0
INSTRUCTIONS FOR USE
Performance Characteristics
TSH
Performance Characteristics
Limit of Detection
The Limit of Detection (LoD) for VITROS TSH is 0.014 mIU/L (IU/mL), determined consistent with NCCLS document EP1720 and with proportions of false positives () less than 1% and false negatives () less than 1%; based on 700 determinations, with 1 blank and 5 low-level samples. The Limit of Blank (LoB) is 0.001 mIU/L (IU/mL). The Limit of Quantitation (LoQ) is 0.097 mIU/L (IU/mL) as determined by the lowest concentration at which precision and accuracy design requirements are still met and within the linear range of the test. For the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, the LoB and LoD were verified consistent with NCCLS document EP17.20 The LoQ was verified using 88 replicate determinations of a test fluid that were collected over a 22 day test interval that included 5 calibration events. A Total Error of 22.8% was used to assess bias between individual determinations of the test fluid and its assigned value. The data presented are a representation of the product performance.
Limit of Blank, Limit of Detection and Limit of Quantitation
LoB* mIU/L (IU/mL) 0.001 LoD** mIU/L (IU/mL) 0.014 LoQ mIU/L (IU/mL) 0.097
* Limit of Blank, or the highest value likely to be observed with a sample containing no analyte, replaces the term "analytical sensitivity." ** Proportions of false positives () and false negatives () were less than 1%; based on 700 determinations, with 1 blank and 5 low-level samples.
Functional Sensitivity
The functional sensitivity of this test is typically 0.015 mIU/L (0.015 IU/mL). Functional sensitivity is defined as the concentration which corresponds to the 20% between-test coefficient of variation from the precision dose profile.21 The functional sensitivity of the VITROS TSH test was calculated across a single 28 day calibration interval, using a human serum matrix. The functional sensitivity of this test was verified on the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System across 5 days, using a human serum matrix.
Accuracy (Method Comparison)
Accuracy was evaluated consistent with NCCLS document EP9.22 The plot and table show the results of a method comparison study using patient serum samples from a variety of clinical categories analyzed on the VITROS ECi/ECiQ Immunodiagnostic System compared with those analyzed using the DPC Immulite Third Generation TSH test. The relationship between the 2 methods was determined by Deming regression.23 The table also shows the results of method comparison studies24 using patient serum and plasma samples analyzed on the VITROS ECi/ECiQ Immunodiagnostic System compared with those analyzed using the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. The relationship between the 2 methods was determined by Passing and Bablok regression.25 Conventional Units Alternate Units
Comparative Method: DPC Immulite Third Generation TSH (mIU/L)
VITROS ECi/ECiQ (IU/mL)
VITROS ECi/ECiQ (mIU/L)
Comparative Method: DPC Immulite Third Generation TSH (IU/mL)
Version 5.0
Pub. No. GEM1001_EN_WW
TSH
INSTRUCTIONS FOR USE
Performance Characteristics
Conventional Units (mIU/L) System ECi/ECiQ vs. Comparative Method 3600 vs. ECi/ECiQ 5600 vs. ECi/ECiQ n Correlation Slope Coefficient 0.996 0.999 0.998 Range of Samples <0.01596.4 0.09195.8 0.09196.0 Intercept 0.252 0.154 0.160 Alternate Units (IU/mL) Range of Samples <0.01596.4 0.09195.8 0.09196.0 Intercept 0.252 0.154 0.160
133 0.974 103 105 1.01 1.02
Precision
VITROS ECi/ECiQ Immunodiagnostic System
Precision was evaluated consistent with NCCLS document EP5.26 Two replicates each of 3 freeze-dried control samples were tested on 2 separate occasions per day on at least 20 different days. The experiment was performed using 2 reagent lots on 2 different systems. The data presented are a representation of the product performance.
VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System
Precision was evaluated consistent with NCCLS document EP5.27 Two replicates of each of 3 freeze-dried control samples were tested on 2 separate occasions per day on at least 20 different days. The experiment was performed using 1 reagent lot on each system. The data presented are a representation of the product performance. Units = mIU/L (IU/mL) Within-run* System ECi/ECiQ system 1 ECi/ECiQ system 2 3600 Mean TSH Conc. 0.169 2.21 40.5 0.162 2.19 38.0 0.074 1.62 24.3 0.078 1.68 25.2 SD 0.00552 0.0317 0.502 0.00866 0.0221 0.508 0.00196 0.0178 0.261 0.00303 0.0152 0.262 CV (%) 3.3 1.4 1.2 5.3 1.0 1.3 2.7 1.1 1.1 3.9 0.9 1.0 Within-calibration** SD 0.0100 0.0729 1.40 0.0120 0.0819 2.05 0.0041 0.0321 0.423 0.0056 0.0379 0.540 CV (%) 5.9 3.3 3.5 7.4 3.7 5.4 5.6 2.0 1.7 7.2 2.3 2.1 Within-lab*** SD 0.0121 0.0885 1.39 0.0142 0.0887 2.10 0.0051 0.0368 0.656 0.0051 0.0351 0.496 CV (%) 7.2 4.0 3.4 8.8 4.1 5.5 6.7 2.3 2.7 6.7 2.1 2.0 No. Observ. 80 80 80 80 80 80 88 88 88 88 88 88 No. Days 20 20 20 20 20 20 22 22 22 22 22 22
5600
* Within-run (repeatability). Between Duplicate precision averaged over all runs ** Within-calibration. Total precision with weighted components of within-run, betweenrun and between-day variation. *** Within-lab. A measure of the effect of recalibration on total precision, calculated within reagent lot, using data from at least 4 calibrations
Specificity
Substances that do not Interfere
The VITROS TSH test was evaluated for interference consistent with CLSI document EP7.13 Of the compounds tested, none was found to cause a bias of >10% with the test at the concentrations indicated at TSH concentrations of 2.022.29 mIU/L (IU/mL). Compound Bilirubin Biotin FSH HCG Hemoglobin* LH Triolein Concentration 0.342 mmol/L 20.0 mg/dL 20.5 nmol/L 0.5 g/dL 1000 IU/L 1000 mIU/mL 500,000 IU/L 500,000 mIU/mL 0.310 mmol/L 500 mg/dL 1000 IU/L 1000 mIU/mL 33.9 mmol/L 3000 mg/dL
* Hemolysate was added to a series of specimens with VITROS TSH concentration of 0.1498.90 mIU/L (IU/mL).
Pub. No. GEM1001_EN_WW
Version 5.0
INSTRUCTIONS FOR USE
References
TSH
References
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. Evered D.: Diseases of the Thyroid Gland. Clinics in Endocrinology and Metabolism 3: 425-450; 1974. Evered DC et al.: Grades of hypothyroidism. British Medical Journal 1: 657-662; 1973. Caldwell G et al.: A new strategy for thyroid function testing. Lancet 1: 1117-1119; 1985. Kerr DJ & Alexander WD.: Is the TRH test usually unnecessary? Lancet 2: 1161-1162; 1984. Spencer CA.: Thyroid profiling for the 1990s: free T4 estimate or sensitive TSH measurement. Journal Clinical Immunology 12: 82-89; 1989. Nicoloff JT & Spencer CA.: The use and misuse of the sensitive thyrotropin assays. Journal of Clinical Endocrinology & Metabolism 71: 553-558; 1990. Summers M et al.: Luminogenic Reagent Using 3-Chloro 4-Hydroxy Acetanilide to Enhance Peroxidase/Luminol Chemiluminescence. Clinical Chemistry 41. S73; 1995. CLSI. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - Third Edition. CLSI document M29-A3 (ISBN 1-56238-567-4). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005. Calam RR.: Specimen Processing Separator Gels: An Update. J Clin Immunoassay 11: 86-90; 1988. CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard Sixth Edition. CLSI document H3-A6 (ISBN 1-56238-650-6). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2007. NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard Fifth Edition. NCCLS document H4-A5 [ISBN 1-56238-538-0]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA, 2004. CLSI. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline - Third Edition. CLSI document C24-A3 [ISBN 1-56238-613-1]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA, 2006. NCCLS. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS document EP7-P (ISBN 1-56238-020-6). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1986. Scientific Committee on Food. Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Biotin. European Commission, SCF/CS/NUT/UPPLEV/55 Final, Brussels, 2001. Levinson SS.: The Nature of Heterophillic Antibodies and Their Role in Immunoassay Interference. J Clin Immunoassay 15: 108-115; 1992. Young DS. Effects of Drugs on Clinical Laboratory Tests ed. 4. Washington, D.C.: AACC Press; 1995. Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. ed. 3. Washington, D.C.: AACC Press; 1997. Tryding N, Tufvesson C, Sonntag O (eds). Drug Effects in Clinical Chemistry. ed. 7. Stockholm: The National Corporation of Swedish Pharmacies, Pharmasoft AB, Swedish Society for Clinical Chemistry; 1996. Keefer JH. Preanalytical considerations in testing thyroid function. Clinical Chemistry 42: 125-134; 1996. NCCLS. Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. NCCLS document EP17-A (ISBN 156238-551-8). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 2004. Spencer CA et al. Interlaboratory/Intermethod Differences in Functional Sensitivity of Immunometric Assays of Thyrotropin (TSH) and Impact of Reliability of Measurement of Subnormal Concentrations of TSH. Clin Chem 41: 367-374, 1995. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS document EP9-A (ISBN 1-56238-283-7). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1995. Deming WE, Statistical Adjustment of Data. New York, NY: John Wiley and Sons; 1943. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition. NCCLS document EP9-A2 (ISBN 1-56238-472-4). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2002. Passing H., W. A New Biometrical Procedure of Testing the Equality of Measurements from Two Different Analytical Methods. J Clin Chem Biochem. 21:709-720 1983. NCCLS. Evaluation of Precision Performance of Clinical Chemistry Devices Second Edition; Tentative Guideline. NCCLS document EP5-T2 (ISBN 1-56238-145-8). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1992. NCCLS. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline Second Edition. CLSI document EP5A2 (ISBN 1-56238-542-9). CLSI, 940 West Valley Road, Suite 1400, Wayne Pennsylvania 19087-1898 USA, 2004.
Version 5.0
Pub. No. GEM1001_EN_WW
TSH
Glossary of Symbols
INSTRUCTIONS FOR USE
Glossary of Symbols
10
Pub. No. GEM1001_EN_WW
Version 5.0
INSTRUCTIONS FOR USE
Revision History
TSH
Revision History
Date of Revision 2010-05-26 Version 5.0 Description of Technical Changes* Measuring (Reportable) Range: amended lot numbers US address: updated Brazilian address: updated Reagent Pack Storage and Preparation: updated wording Quality Control Procedure Recommendations: updated wording Limit of Detection: updated wording Brazilian address: updated New format that combines the following into one document: TSH Reagent Pack (GEM1001_EN_XUS), version 2.0 TSH Reagent Pack (J03776_EN_US), version 2.0 TSH Calibrators (GEMC001_EN_WW), version 1.0 Added information for the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Updated risk and safety statements Measuring (Reportable) Range: added lower limit based on functional sensitivity for the VITROS Immunodiagnostic and VITROS Integrated Systems Other Limitations: added azide statement Limit of Detection: added new section Analytical Sensitivity: removed section References: updated Glossary of Symbols: updated
2009-09-16
4.0
2008-11-11
3.0
The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.
When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory policies, as appropriate.
_________________________________ Signature
_____________ Obsolete Date
Version 5.0
Pub. No. GEM1001_EN_WW
11
TSH
INSTRUCTIONS FOR USE
Revision History
Conditions of supply: all supplies are made subject to the standard terms and conditions of Ortho-Clinical Diagnostics or its distributors. Copies of these are available on request.
Distributed in the US by: Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626
Ortho-Clinical Diagnostics Johnson & Johnson 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4DP United Kingdom
VITROS is a trademark of Ortho-Clinical Diagnostics, Inc. Ortho-Clinical Diagnostics, Inc., 2008-2010.
12
Pub. No. GEM1001_EN_WW
Version 5.0
