FSH - MagnaBioSciences
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1. MagnaBbiosciences LLC a Quantum Design International company gt 2 Quantitative FSH Test in Human Serum 850002 INTENDED USE MICT FSH is an in vitro diagnostic test for the quantitative measurement of follicle stimulating hormone FSH levels in human serum using the MICT System INTRODUCTION Follicle stimulating hormone FSH is a glycoprotein with a molecular weight of approximately 30KD It is produced by the pituitary gland in response to gonadotropin releasing hormone GnRH secreted by the hypothalamus I FSH is a heterodimer composed of two different sub units alpha a and beta 8 The a sub unit contains 89 amino acids is common to other gonadotropins such as LH hCG and TSH The B sub unit contains 118 amino acids is specific for 1 FSH and confers its biochemical specificity FSH stimulates the growth and maturation of the ovarian follicles in women spermatogenesis and the maturation of germ cells in men Immunoassays for serum levels of FSH and for luteinizing hormone LH are useful in the evaluation of disorders of reproduction and puberty such as hypogonadism ovulation irregularity and infertility In addition serum levels of FSH and LH are monitored in ovulation induction and in the clinical administration of gonadotropins PRINCIPLE OF THE TEST MICT FSH is a magnetic immuno chromatographic test MICT using Super Para magnetic Particles SPMPs as the labeling agent The SPMP mag2. ble with a maximum time limit of 2 hours from centrifugation Remove any residual fibrin or cellular matter Turbid serum samples containing particular matter should be transferred from the original tube and re centrifuged prior to assay Samples should be tested within 8 hours of blood draw ASSAY PROCEDURE Open the foil pouch take out the conjugate tube and the test cassette Place the cassette on a dry flat surface The cassette should be used immediately after opening the pouch Mark patient ID on the cassette as necessary Hold the conjugate tube or place it in a rack Make sure that the small conjugate pellet is at the bottom of the tube by gently tapping the wall of the tube Use a standard 100 uL pipette and add 100 uL of patient serum sample into the conjugate tube Mix the serum with the lyophilized conjugate pellet by pipetting up and down 8 4 times Use the same pipette tip from the previous step transfer the entire contents of the mixed solution into the sample well on the test cassette Set a timer and wait for 30 minutes After the 30 minutes insert the test cassette into the MICT instrument and close the door The instrument will immediately initiate the barcode reading and perform test verification In approximately 10 15 seconds the verification will be complete as indicated by the illuminated green READY light Verify test name and sample source displayed on the instrument screen input patient ID an
3. d or patient number and then press the START button This initiates the MICT analysis of the test and control lines The FSH serum concentration in mIU mL is displayed and printed For detailed instructions on how to use the MICT instrument refer to the MICT Instrument User Manual RESULTS The MICT instrument automatically determines FSH concentration in the sample using the information on the cassette barcode label CALIBRATION A calibration master curve is generated for each lot of MICT FSH using master calibrators referenced to the WHO 2 international standard for human FSH IS 94 632 The master curve information is transferred to the MICT instrument through the barcode label on the test cassette The MICT TSH assay requires no calibration at the customer site MICT FSH 148002 Rev B MagnaBioSciences LLC Page 2 of 6 QUALITY CONTROL A MICT Instrument Verification The performance of the MICT instrument can be tested on a regular basis using the verification cassette Supplied with the MICT instrument The verification cassette contains three test regions on the strip that are pre measured and are stable magnetic signals These signals are used to verify the instrument internal calibration and system performance After inserting the verification cassette the MICT instrument will perform a series of measurements and compare the results to the calibrated values stored in the test device barcode Verification results shoul
4. d pass on all test items including the Overall Test Accuracy and Noise B Built in Procedural Control A built in control line is present to assure that 1 reagents and test devices are functional 2 test procedures are carried out correctly and 3 test results are valid If the control line value does not meet the specific QC standard an error message will appear indicating that the test is invalid If this occurs the test must be repeated C FSH Controls Good laboratory practice including the use of control materials should be followed to ensure the test performance Follow the federal state and local requirements for each individual laboratory If FSH controls are out of range re run the test If the problem continues contact MagnaBioSciences or your local distributors for technical support LIMITATION OF PROCEDURE The performance of the MICT FSH has been established using serum samples only Specimens can be measured within the reportable range For accurate results serum FSH levels greater than 100 mIU mL should be tested with another method Specimens from patients who have been exposed to mouse monoclonal antibodies may interfere with the test results and show falsely elevated or depressed FSH values For diagnostic purposes the MICT FSH results should always be assessed in conjunction with other diagnostic findings and information obtained by the physician If the FSH level is inconsistent with clinical evidence ad
5. ditional FSH testing is suggested to confirm the result _MICT FSH immunoassay does not show a high dose hook effect up to 5 000 mIU mL EXPECTED RANGE Expected values in serum for FSH are summarized in the table below Ea a Females Midcycle Peak Luteal Phase 133 1008 PERFORMANCE CHARACTERISTICS Precision The reproducibility of MICT FSH was measured by duplicate testing of pooled serum samples n 60 over a ten day period using two MICT Systems and two lots of MICT FSH tests The test precision data are summarized below MICT FSH Precision CV Mean FSH Between Run Between Analyzer Between Reagent Lot TOTAL mIU mL CV CV CV CV 13 5 a ee ee 2 46 oo O 20 T 5o o T mos 3s as 70 30 40 86 MICT FSH 148002 Rev B MagnaBioSciences LLC Page 3 of 6 Method Comparison One hundred and twenty three 123 clinical samples were used to compare the serum values measured by the MICT FSH and the Siemens ADVIA Centaur FSH immunoassay The agreement of the two methods was evaluated using Demings regression analysis Pearson correlation r value was used to test association between the values Range of Observations mIU mL Intercept mlU mL Slope r 0 3 128 Linearity Linearity was determined in accordance with CLSI protocol EP6 A High and low value patient serum samples were used to prepare a set of linearity samples The two samples were mixed in different ratios a
6. ls required but not provided MICT Instrument 100 mini pipette Serum collection tube Centrifuge Timer MICT FSH 148002 Rev B MagnaBioSciences LLC Page 1 of 6 STORAGE Store at 1 30 C PRECAUTIONS The test is designed for in vitro diagnostics and is for professional use only Wear protective gloves and masks throughout the test procedure Wash hands thoroughly after handling specimens Do not pipette by mouth Do not eat drink or smoke in designated work areas Follow standard guidelines for proper handling and disposal of patient specimens chemical reagents used cassettes and all other materials used during the test MICT tests are stable within the expiration date when stored and handled as directed Do not use MICT tests beyond the expiration date Do not use a cassette from a compromised pouch Specimens with repeated freeze thaw cycles can cause abnormal results SPECIMEN COLLECTION AND STORAGE For handling processing and storing blood samples read the following notes as well as the manufacturer s procedures on sample collection tubes Follow routine procedures and precautions for venipuncture Draw blood into serum collection tubes Keep the tubes sealed at all times For serum samples allow blood to clot completely before centrifugation Samples should be centrifuged and refrigerated within 2 hours of blood draw Serum should be physically separated from cells as soon as possi
7. nd the FSH values determined using the MICT system and the results compared them with expected values The graph below summarizes the data Linearity Plot FSH mIU mL Measured FSH mIU mL Expected Interfering Substances Interfering substances were added to serum samples containing known amounts of FSH The value obtained for the serum with each interfering substance was compared to the value obtained for the serum without the interfering substance These additives did not show interference at the levels indicated Additives 20 mg dL 300 mg dL 1 000 mg dL Sensitivity and Assay Range Two lots of the MICT FSH test were evaluated for sensitivity using the CLSI EP17 A protocol The LOB LOD and LOQ are summarized as the average obtained from the two lots Sensitivity Parameter mlU mL Limit of Blank LOB Limit of Detection LOD Limit of Quantitation LOQ The assay range is 0 22 mIU mL to 100 mIU mL MICT FSH 148002 Rev B MagnaBioSciences LLC Page 4 of 6 Specificity The antibodies used in the MICT FSH were tested for potential cross reactivity against the closely related hormones TSH hCG and LH The results are summarized below Hormone Concentration _ Cross Reactivity 2 mIU mL 200K mIU mL 3000 mIU mL MICT FSH 148002 Rev B MagnaBioSciences LLC Page 5 of 6 REFERENCES 1 Rose MP Rose E Das G and Balen AH Definition and Measurement of Follicle Stimulating Hormone Endocrine Review
8. netic field is quantified by a MICT Instrument MICT FSH is based on the principle of capillary flow and separation of immune complexes bound to SPMPs within a porous matrix In the test device FSH antibody Ab antigen Ag immune reactions occur on a narrow strip of capillary membrane The narrow strip is housed in a disposable plastic cassette to form a test device The specimen containing the FSH antigens is mixed with a lyophilized conjugate pellet and added into the sample well of the MICT cassette As the FSH Ab Ag SPMP immune complexes migrate through the test strip they are captured by the second antibodies at the test line A Control line is formed by the control SPMP immune complexes The MICT instrument is used to analyze the quantity of magnetic particles captured on both control and test lines A visible line is not necessary for interpreting the MICT test result The FSH concentration is directly proportional to the magnetic signal and is reported based on the predetermined test algorithms that are embedded in the cassette barcode labels REAGENTS AND EQUIPMENT Reagents and materials supplied e MICT FSH Device packs 20 Each pack contains 1 MICT FSH cassette which contains murine monoclonal anti FSH antibodies test line and control goat anti rabbit IgG polyclonal antibodies control line and 1 lyophilized FSH antibody conjugate tube which contains anti FSH monoclonal antibodies covalently coupled to the SPMPs Materia
9. s 2000 21 1 5 22 2 Dahl KD and Stone MP FSH Isoforms Radioimmunoassays Bioassays and their Significance J of Andrology 1992 13 11 22 3 Scott MG Ladenson JH Green ED et al Hormonal Evaluation of Female Infertility and Reproductive Disorders Clin Chem 1989 35 620 29 4 Hayes FJ Sluss PM Reproductive Endocrinology In Lewandrowski K editor Clinical Chemistry Laboratory Management and Clinical Correlates New York Lippincott Williams and Williams 2002 p 625 38 5 Demiers LM Pituitary Function In Burtis CA and Ashwood ER editors Tietz Textbook of Clinical Chemistry W B Saunders Company 1999 p 1485 ECIREP a 30 C TECHNOLOGY promedt AltenhofstraRe 80 D 66386 St Ingbert Germany Tel 49 0 6894 581020 www mt procons com TECHNICAL SUPPORT For direct technical assistance contact your local distributor or MagnaBioSciences 6325 Lusk Blvd San Diego CA 92121 USA MagnaBioSciences LLC TEL 1 858 481 4400 FAX 1 858 481 7410 a Quantum Design International company e Email info magnabiosciences com powered by mAAR The MICT measurement technology and assays are covered by US Patents 6 046 585 6 275 031 6 437 563 6 483 303 6 518 747 6 597 176 6 607 922 6 927 570 and foreign equivalents Other patents are pending MICT FSH 148002 Rev B MagnaBioSciences LLC Page 6 of 6
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