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INHIBIN A

A36097
Intended Use The Access Inhibin A assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of dimeric inhibin A in human serum and plasma (heparin and EDTA) as an aid in the diagnosis and monitoring of various hormonal reproductive disorders using the Access Immunoassay Systems. Inhibins are heterodimeric protein hormones secreted by granulosa cells of the ovary in the female and Sertoli cells of the testis in the male. They selectively suppress the secretion of pituitary follicle stimulating hormone (FSH) and also have local paracrine actions in the gonads.1,2 The fully processed form of the inhibin molecule has a molecular weight of approximately 32 kD and consists of the two distinct chains ( and ), linked by disulfide bridges. Higher molecular weight forms, with precursor forms of the -subunit, also occur in follicular fluid and serum. In addition, free -subunit forms, unassociated with a -subunit and lacking inhibin bioactivity, are also present.3,4,5,6 Inhibin A consists of an -subunit and a A-subunit. Measurements of Inhibin A have been shown to be useful in studies of human reproductive physiology.7,8,9 Several published reports indicate the utility of inhibin A measurement as an endocrine marker for monitoring ovarian function.10,11,12,13,14,15,16 The Access Inhibin A assay is a sequential two-step immunoenzymatic (sandwich) assay. A sample is added to a reaction vessel and incubated with paramagnetic particles coupled with anti-inhibin A monoclonal antibody. Excess sample and reagents are removed by washing. Anti-inhibin A monoclonal antibody-alkaline phosphatase conjugate is then added to a reaction mixture in order to detect inhibin A bound to the particles during the previous incubation. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate Lumi-Phos* 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of inhibin A in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve. Access Inhibin A Reagent Pack Cat. No. A36097: 100 determinations, 2 packs, 50 tests/pack Provided ready to use. Store upright and refrigerate at 2 to 8C. Refrigerate at 2 to 8C for a minimum of two hours before use on the instrument. Stable until the expiration date stated on the label when stored at 2 to 8C. Stable at 2 to 8C for 28 days after initial use. Signs of possible deterioration are a broken elastomeric layer on the pack or control values out of range. If the reagent pack is damaged (i.e., broken elastomer), discard the pack. All antisera are monoclonal unless otherwise indicated.

Summary and Explanation

Principles of the Procedure

Product Information

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R1a:

Paramagnetic particles coated with mouse monoclonal anti-inhibin A, BSA, TRIS buffered matrix, < 0.1% sodium azide, and 0.1% ProClin** 300. Mouse monoclonal anti-inhibin A alkaline phosphatase (bovine) conjugate, BSA, phosphate buffered matrix, < 0.1% sodium azide, and 0.25% ProClin 300. TRIS buffered saline, BSA, proteins (bovine, murine), < 0.1% sodium azide, and 0.25% ProClin 300. Phosphate buffer, oxidizer. TRIS buffer, detergents, < 0.1% sodium azide, and 0.1% ProClin 300.

R1b:

R1c: R1d: R1e: Warnings and Precautions

For in vitro diagnostic use. Patient samples and blood-derived products may be routinely processed with minimum risk using the procedure described. However, handle these products as potentially infectious according to universal precautions and good clinical laboratory practices, regardless of their origin, treatment, or prior certification. Use an appropriate disinfectant for decontamination. Store and dispose of these materials and their containers in accordance with local regulations and guidelines. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal of liquids, flush with a large volume of water to prevent azide build-up.17 Xi. Irritant: 0.25% ProClin 300. R 43: May cause sensitization by skin contact. S 28-37: After contact with skin, wash immediately with plenty of soap and water. Wear suitable gloves. The Material Safety Data Sheet (MSDS) is available upon request.

Specimen Collection and Preparation

1. Serum and plasma (heparin and EDTA) are the recommended samples. 2. Observe the following recommendations for handling, processing, and storing blood samples:18 Collect all blood samples observing routine precautions for venipuncture. Allow serum samples to clot completely before centrifugation. Keep tubes stoppered at all times. Within two hours after centrifugation, transfer at least 500 L of cell-free sample to a storage tube. Tightly stopper the tube immediately. Store samples tightly stoppered at room temperature (15 to 30C) for no longer than eight hours. If the assay will not be completed within eight hours, refrigerate the samples at 2 to 8C. If the assay will not be completed within 48 hours, or for shipment of samples, freeze at -20C or colder. Thaw samples only once. 3. Use the following guidelines when preparing specimens: Ensure residual fibrin and cellular matter have been removed prior to analysis. Follow blood collection tube manufacturers recommendations for centrifugation. 4. Each laboratory should determine the acceptability of its own blood collection tubes and serum separation products. Variations in these products may exist between manufacturers and, at times, from lot-to-lot. 5. Avoid assaying lipemic/ hemolyzed samples.

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Materials Provided Materials Required But Not Provided

R1

Access Inhibin A Reagent Packs

1. Access Inhibin A Calibrators Provided at zero and approximately 10, 50, 100, 500, 1000, and 1500 pg/mL. Cat. No. A36098 2. Access Inhibin A Quality Control (QC) (Provided at approximately 150, 400, and 800 pg/mL) or other commercially available control material. Cat. No. A36100 3. Access Sample Diluent A Cat. No. 81908 4. Access Substrate Cat. No. 81906 5. Access, Access 2, SYNCHRON LXi, UniCel DxC 600i: Access Wash Buffer II, Cat. No. A16792 UniCel DxI: UniCel DxI Wash Buffer II, Cat. No. A16793 1. Refer to the appropriate system manuals and/or Help system for a specific description of installation, start-up, principles of operation, system performance characteristics, operating instructions, calibration procedures, operational limitations and precautions, hazards, maintenance, and troubleshooting. 2. Mix contents of new (unpunctured) reagent packs by gently inverting pack several times before loading on the instrument. Do not invert open (punctured) packs. 3. Use 70 L of sample for each determination in addition to the sample container and system dead volumes. Refer to the appropriate system manuals and/or Help system for the minimum sample volume required. 4. The system default unit of measure for sample results is pg/mL. To change sample reporting units to the International System of Units (SI units), IU/mL, refer to the appropriate system manuals and/or Help system. To manually convert concentrations to the International System, divide pg/mL by 25.1. Refer to the appropriate system manuals and/or Help system for information on managing samples, configuring tests, requesting tests, and reviewing test results. An active calibration curve is required for all tests. For the Access Inhibin A assay, calibration is required every 28 days. Refer to the appropriate system manuals and/or Help system for information on calibration theory, configuring calibrators, calibrator test request entry, and reviewing calibration data. Quality control materials simulate the characteristics of patient samples and are essential for monitoring the system performance of immunochemical assays. Because samples can be processed at any time in a random access format rather than a batch format, quality control materials should be included in each 24-hour time period.19 Include Access Inhibin A QC or other commercially available quality control materials that cover at least three levels of analyte. Follow manufacturers instructions for reconstitution and storage. Each laboratory should establish mean values and acceptable ranges to assure proper performance. Quality control results that do not fall within acceptable ranges may indicate invalid test results. Examine all test results generated since obtaining the last acceptable quality control test point for this analyte. Refer to the appropriate system manuals and/or Help system for information about reviewing quality control results.

Procedural Comments

Procedure

Calibration Details

Quality Control

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Results

Patient test results are determined automatically by the system software using a smoothing spline math model. The amount of analyte in the sample is determined from the measured light production by means of the stored calibration data. Patient test results can be reviewed using the appropriate screen. Refer to the appropriate system manuals and/or Help system for complete instructions on reviewing sample results. 1. Samples can be accurately measured within the analytic range of the lower limit of detection and the highest calibrator value (approximately 11500 pg/mL). If a sample contains less than the lower limit of detection for the assay, report the result as less than that value (i.e., < 1 pg/mL). If a sample contains more than the stated value of the highest Access Inhibin A Calibrator (S6) report the result as greater than that value (i.e., > 1500 pg/mL). Alternatively, dilute one volume of sample with 2 or 10 volumes of Access Sample Diluent A. Refer to the appropriate system manuals and/or Help system for instructions on entering a sample dilution in a test request. The system reports the results adjusted for the dilution. 2. For assays employing antibodies, the possibility exists for interference by heterophile antibodies in the patient sample. Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies, e.g. HAMA, that interfere with immunoassays. Additionally, other heterophile antibodies such as human anti-goat antibodies may be present in patient samples.20,21 Such interfering antibodies may cause erroneous results. Carefully evaluate the results of patients suspected of having these antibodies. 3. The Access Inhibin A results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information. 4. The Access Inhibin A assay does not demonstrate any hook effect. 5. Occasional third trimester pregnancy samples (2740 weeks gestation) demonstrate non-linear dilution when diluted in Access Sample Diluent A. 6. This kit is not intended to be used for the risk evaluation of trisomy 21. 1. Each laboratory should establish its own reference ranges to assure proper representation of specific populations. 2. Serial, serum samples (n 13) were collected from 98 females across one menstrual cycle. Inhibin A concentrations were measured using the Access Inhibin A assay. The median and 95% central fraction limits are listed in the table below. Postmenopausal females and normal males were also tested and all results were near the analytical sensitivity of the Access Inhibin A assay.
Population
Normal Cycling Females (days from LH surge) Early Follicular Phase (-14 to -10) Mid Follicular Phase (-9 to -4) Late Follicular Phase (-3 to -1) Mid-Cycle (Day 0, LH surge) Early Luteal Phase (1 to 3) Mid Luteal Phase (4 to 11) Late Luteal Phase (12 to 14) Postmenopausal Females Males 211 264 121 96 122 344 138 58 67 6.4 11.7 29.0 41.8 43.7 38.3 12.5 1.1 1.1 1.8 3.5 9.8 16.9 16.1 3.9 2.7 < 1.0 < 1.0 17.3 31.7 90.3 91.8 97.5 87.7 47.1 2.1 2.0

Limitations of the Procedure

Expected Values

Median (pg/mL)

2.5% Lower Limit (pg/mL)

97.5% Upper Limit (pg/mL)

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Specific Performance Characteristics

Methods Comparison

A comparison of 124 values generated from first and second trimester pregnant female serum samples using the Access Inhibin A assay on the Access Immunoassay system and a commercially available immunoassay kit gave the following statistical data using Passing-Bablock. The 95% CI is shown for the slope and intercept.
Range of Observations (pg/mL)
75570

n
124

Intercept (pg/mL)
-0.894 (-8.74 6.64)

Slope
0.958 (0.92 1.00)

Correlation Coefficient (r)


0.97

Dilution Recovery (Linearity)

Serial dilutions of three serum samples, from pregnant females in their second trimester of pregnancy, were diluted in Access Sample Diluent A. The recovery results are summarized in the following tables:
Patient 1
Neat 1:2 1:4 1:8 1:16 1:32

Expected
574.25 287.13 143.56 71.78 35.60 17.80

Recovery (%)
NA 116.20 110.27 123.08 118.67 108.00 115

Mean % Recovery

Patient 2
Neat 1:2 1:4 1:8 1:16 1:32

Expected
115.07 57.53 28.77 14.38 7.13 3.57

Recovery (%)
NA 103.59 105.33 105.16 102.68 93.21 102

Mean % Recovery

Patient 3
Neat 1:2 1:4 1:8 1:16 1:32

Expected
197.60 98.80 49.40 24.70 12.25 6.13

Recovery (%)
NA 111.03 111.59 108.10 99.79 101.62 106

Mean % Recovery

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Imprecision

This assay exhibits total imprecision 8% at concentrations greater than 30 pg/mL. One study, using spiked and unspiked human female serum samples generating a total of 80 assays, 2 replicates per assay, over 20 days provided the following data, analyzed via analysis of variance (ANOVA).22, 23
Mean Dose (pg/mL)
51.633 78.456 176.239 331.710 676.600

Sample
1 2 3 4 5

Within Run (%CV)


4.04 4.17 4.01 3.96 3.83 Mean = 4.00%

Between Run (%CV)


4.28 2.91 3.72 2.91 6.05 Mean = 3.97%

Total Imprecision (%CV)


5.89 5.09 5.47 4.91 6.05 Mean = 5.48%

Analytical Specificity/Interferences

The following drugs/interferents were added at the concentrations indicated below to normal female serum samples. All Inhibin A values obtained in the presence of each drug/interferent indicate that these substances do not interfere with the assay.
Drug/interferent Acetaminophen Bilirubin Hemoglobin Human serum albumin Ibuprofen Salicylic acid Triolein Concentration tested
200 g/mL 400 g/mL 5 mg/mL 6 mg/mL 400 g/mL 500 g/mL 5 mg/mL

Each of the following potential cross-reacting proteins were added in the concentrations listed to Access Inhibin A Calibrator S0 and assayed in replicates of five. The data presented below indicates no significant cross-reactivity in the Access Inhibin A assay.
Substance
2Macroglobulin Activin A Activin AB Activin B AFP Follistatin hCG LH Prolactin TSH

Analyte Added (g/mL)


10 1 1 1 20 1 10 100 100 100

% CrossReactivity
< 0.001% -0.006% -0.002% -0.003% < 0.001% < 0.001% < 0.001% < 0.001% < 0.001% < 0.001%

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Analytical Sensitivity

The lowest detectable level of Inhibin A distinguishable from zero (Access Inhibin A Calibrator S0) with 95% confidence is < 1 pg/mL. This value is determined by processing a complete seven point calibration curve, controls, and 10 replicates of the zero calibrator in multiple assays. The analytical sensitivity value is calculated from the curve at the point that is two standard deviations from the mean measured zero calibrator signal.

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INHIBIN A CALIBRATORS
A36098
Intended Use The Access Inhibin A Calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric inhibin A levels in human serum and plasma (heparin and EDTA) as an aid in the diagnosis and monitoring of various hormonal reproductive disorders using the Access Immunoassay Systems. Quantitative assay calibration is the process by which samples with known analyte concentrations (i.e., assay calibrators) are tested like patient samples to measure the response. The mathematical relationship between the measured responses and the known analyte concentrations establishes the calibration curve. This mathematical relationship, or calibration curve, is used to convert RLU (Relative Light Unit) measurements of patient samples to specific quantitative analyte concentrations. The measurand (analyte) in the Access Inhibin A Calibrators is traceable to the manufacturers working calibrators. Traceability process is based on EN ISO 17511. To convert sample values obtained with the Access Inhibin A kit to equivalent WHO 91/624 units, use the equation below. WHO (91/624) equivalent value (IU/mL) = Access Inhibin A value (pg/mL) divided by 25.1. The assigned values were established using representative samples from this lot of calibrator and are specific to the assay methodologies of the Access reagents. Values assigned by other methodologies may be different. Such differences, if present, may be caused by inter-method bias. Product Information Access Inhibin A Calibrators Cat. No. A36098: S0S6, 2.5 mL/vial Provided ready to use. Store upright and refrigerate at 2 to 8C. Mix contents by gently inverting before use. Avoid bubble formation. Unopened vial is stable until the expiration date stated on the label when stored at 2 to 8C. Opened vial is stable at 2 to 8C for 28 days after initial use. Signs of possible deterioration are control values out of range. Refer to calibration card for exact concentrations.
r

Summary and Explanation

Traceability

S0: S1, S2, S3, S4, S5, S6: Calibration Card:

Buffered BSA matrix, < 0.1% sodium azide, and 0.5% ProClin** 300. Contains 0.0 pg/mL inhibin A. Recombinant human inhibin A at levels of approximately 10, 50, 100, 500, 1000, and 1500 pg/mL, respectively, in buffered BSA matrix, < 0.1% sodium azide, 0.5% ProClin 300. 1

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Warnings and Precautions

For in vitro diagnostic use. Patient samples and blood-derived products may be routinely processed with minimum risk using the procedure described. However, handle these products as potentially infectious according to universal precautions and good clinical laboratory practices, regardless of their origin, treatment, or prior certification. Use an appropriate disinfectant for decontamination. Store and dispose of these materials and their containers in accordance with local regulations and guidelines. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal of liquids, flush with a large volume of water to prevent azide build-up.17 Xi. Irritant: 0.5% ProClin 300. R 43: May cause sensitization by skin contact. S 28-37: After contact with skin, wash immediately with plenty of soap and water. Wear suitable gloves. The Material Safety Data Sheet (MSDS) is available upon request.

Procedure

Refer to the appropriate system manuals and/or Help system for information on calibration theory, configuring calibrators, calibrator test request entry, and reviewing calibration data. The Access Inhibin A Calibrators are provided at 7 levels zero and approximately 10, 50, 100, 500, 1000, and 1500 pg/mL. Assay calibration data are valid up to 28 days. Calibrators run in duplicate.

Calibration Details

Limitations of the Procedure

If there is evidence of microbial contamination or excessive turbidity in a reagent, discard the vial.

2007 Beckman Coulter, Inc.

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INHIBIN A QC
A36100
Intended Use The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay. Quality control materials simulate the characteristics of patient samples and are essential for monitoring the system performance of the Access Inhibin A immunoassay. In addition, they are an integral part of good laboratory practices.19,24,25,26,27,28 When performing assays with Access reagents for inhibin A, include quality control materials to validate the integrity of the assays. The assayed values should fall within the acceptable range if the test system is working properly. The measurand (analyte) in the Access Inhibin A QC is traceable to the manufacturers working calibrators. Traceability process is based on EN ISO 17511. The assigned values were established using representative samples from this lot of QC and are specific to the assay methodologies of the Access reagents. Values assigned by other methodologies may be different. Such differences, if present, may be caused by inter-method bias. Product Information Access Inhibin A QC Cat. No. A36100: 2.5 mL/vial, 2 vials each level Provided ready to use. Store upright and refrigerate at 2 to 8C. Mix contents by gently inverting before use. Avoid bubble formation. Unopened vial is stable until the expiration date stated on the label when stored at 2 to 8C. Opened vial is stable at 2 to 8C for 28 days after initial use. Signs of possible deterioration are control values out of range. Refer to the QC value card for mean values and standard deviations (SD). QC 1: QC 2: QC 3: QC Value Card: Warnings and Precautions Recombinant human inhibin A at a level of approximately 150 pg/mL, buffered BSA matrix, < 0.1% sodium azide, and 0.5% ProClin** 300. Recombinant human inhibin A at a level of approximately 400 pg/mL, buffered BSA matrix, < 0.1% sodium azide, and 0.5% ProClin 300. Recombinant human inhibin A at a level of approximately 800 pg/mL, buffered BSA matrix, < 0.1% sodium azide, and 0.5% ProClin 300. 1

Summary and Explanation

Traceability

For in vitro diagnostic use. Patient samples and blood-derived products may be routinely processed with minimum risk using the procedure described. However, handle these products as potentially infectious according to universal precautions and good clinical laboratory practices, regardless of their origin, treatment, or prior certification. Use an appropriate disinfectant for decontamination. Store and dispose of these materials and their containers in accordance with local
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regulations and guidelines. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal of liquids, flush with a large volume of water to prevent azide build-up.17 Xi. Irritant: 0.5% ProClin 300. R 43: May cause sensitization by skin contact. S 28-37: After contact with skin, wash immediately with plenty of soap and water. Wear suitable gloves. The Material Safety Data Sheet (MSDS) is available upon request. Procedure Determine the concentration of inhibin A in the Access Inhibin A QC materials using the Access Immunoassay System in the same manner as a patient sample. Refer to the appropriate system manuals and/or Help system for information on quality control theory, configuring controls, quality control sample test request entry, and reviewing quality control data. If there is evidence of microbial contamination or excessive turbidity in a reagent, discard the vial. For the value assignment of the Access Inhibin A QC material, a number of samples, representative of the entire lot, are selected and assayed to provide a reliable estimate of the mean value. The mean values and standard deviations are listed on the QC value card. Variations, such as in technique, equipment, or reagents may result in values different from those listed. Therefore, each laboratory should establish its own mean values and standard deviations (SD).

Limitations of the Procedure Expected Values

2007 Beckman Coulter, Inc.

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SAMPLE DILUENT A
81908
Intended Use The Access Sample Diluent A is intended for use with Access assays to dilute patient samples containing analyte concentrations greater than the analyte specific S6 calibrator. The analyte level in patient samples may exceed the level of the specific S6 calibrator. If a quantitative value is required, it will be necessary to dilute the samples in order to determine the analyte concentration. Access Sample Diluent A Cat. No. 81908: 4 mL/vial Provided ready to use. Allow the contents to stand for 10 minutes at room temperature. Mix gently by inverting before use. Avoid bubble formation. Stable until the expiration date stated on the vial label when stored at 2 to 10C. Diluent: Warnings and Precautions Buffered BSA matrix with surfactant, < 0.1% sodium azide, 0.5% ProClin** 300.

Summary and Explanation

Product Information

For in vitro diagnostic use. Patient samples and blood-derived products may be routinely processed with minimum risk using the procedure described. However, handle these products as potentially infectious according to universal precautions and good clinical laboratory practices, regardless of their origin, treatment, or prior certification. Use an appropriate disinfectant for decontamination. Store and dispose of these materials and their containers in accordance with local regulations and guidelines. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal of liquids, flush with a large volume of water to prevent azide build-up.17 Xi. Irritant: 0.5% ProClin 300. R 43: May cause sensitization by skin contact. S 28-37: After contact with skin, wash immediately with plenty of soap and water. Wear suitable gloves. The Material Safety Data Sheet (MSDS) is available upon request.

Procedure

Samples can be accurately measured within the analytic range of the lower limit of detection and the highest calibrator value of the specific assay. If a sample contains more analyte than the stated value of the S6 calibrator, dilute the sample following dilution instructions in the specific assay labeling under Limitations of the Procedure in the reagent pack section. Refer to the appropriate system manuals and/or Help system for instructions on how to enter a sample dilution in a test request.

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Limitations of the Procedure

If there is evidence of microbial contamination or excessive turbidity in the reagent, discard the vial.

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References

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Vale, WW, Hseuh A, Rivier C, Yu J. The inhibin/activin family of hormones and growth factors. In: Sporn MA and Roberst AB, eds. Peptide growth factors and their receptors: handbook of experimental physiology. Vol 95, Berlin, Springer-Verlag, 1990, 211-248. Burger HG. Evidence for a negative feedback role of inhibin in follicle stimulating hormone regulation in women. Hum Reprod 1993; Suppl 2:129-32. Knight PG, Beard AJ, Wrathall HM, Castillo RJ. Evidence that the bovine ovary secretes large amounts of monomeric inhibin subunit and its isolation from bovine follicular fluid. J Mol Cell Endocrinol. 1989; 2:189-200. Schneyer AL, Sluss PM, Whitcomb RW, Martin KA, Sprengel R, Crowley WF. Precursors of a-inhibin modulate FSH receptor binding and biological activity. Endocrinology. 1991; 129:1987-1999. Robertson DM, Sullivan J, Watson M, Cahir N. Inhibin forms in human plasma. J Endocrinol. 1995; 144:261- 269. Robertson D, Burger HG, Sullivan J, Cahir N, Groome N, Poncelet E, Franchimont P, Woodruff T, Mather JP. Biological band Immunological Characterization of Inhibin Forms in Human Plasma. J Clin Endocrinol & Metab. 81:669-676. Lockwood GM, Muttukrishna S, Ledger WL. Inhibins and activins in human ovulation, conception and pregnancy. Human Reprod Update, 1994; vol. 4 no. 3:284-295. Groome NP, Illingworth PJ, OBrien M, Cooke I, Ganesan TS, Baird DT, and McNeilly A. Detection of Dimeric Inhibin throughout the human menstrual cycle by two-site enzyme immunoassay. Clin Endocrinol. 1994; 40:717-723. Lambert-Messerlian, G., Hall JE, Sluss P, Taylor AL, Martin KA, Groome NP, Crowley WF and Scheyer A. Relatively low levels of Dimeric Inhibin circulate in men and women. J Clin Endocrinol Metab. 1994; 79:45- 50. Muttukrishna S., Fowler PA, Groome NP, Mitchell GC, Robertson WR and Knight PG. Serum concentrations of Dimeric Inhibin during the spontaneous human menstrual cycle and after treatment with exogenous gonadotrophin. Human Reproduction 1994; 9:1634-1642. Lockwood, GM, Muttukrishna, S, Groome, NP, Knight, PG, Ledger, L. Circulating inhibins and activin-A during GnRH downregulation and ovarian hyperstimulation with recombinant FSH for in-vitro fertilization-embryo transfer. Clin Endocrinol. 1996; 45:741-748. Lindheim SR, Chang PL, Vidali A, Ferin M, Sauer MV. The utility of progesterone and Inhibin A for monitoring natural-cycle IVF-ET. J. Assist Reprod Genet. 1998; 15:538-541. Rombauts L, Verhoeven G, Meuleman C, Koninckx PR, Poncelet E, Franchimont P. Dimeric Inhibin A and alpha-subunit immunoreactive maternal serum during spontaneous and in vitro fertilization pregnancies. J Clin Endocrinol Metabol. 1996; 81:985-989. Hall JE, Welt CK, Cramer DW. Inhibin A and inhibin B reflect ovarian function in assisted reproduction but are less useful at predicting outcome. Human Reprod. 1999; 14:409-415. Croftom PM, Illingworth PJ, Groome NP, Stirling HF, Swanston I, Gow S, Wu FCW, McNeilly A, Kelnar CJH. Changes in dimeric inhibin A during normal early puberty in boys and girls. Clin Endocrinol. 1997; 46:109-114. Lockwood GM, Ledger WL, Barlow DH, Groome NP, Muttukrishna S. Measurement of inhibin an activin in early human pregnancy: Demonstration of fetoplacental origin and role in prediction of early-pregnancy outcome. Biology of Reproduction 1997; 57:1490-1494. DHHS (NIOSH) Publication No. 78-127, August 1976. Current Intelligence Bulletin 13 - Explosive Azide Hazard. Available http://www.cdc.gov/niosh. Approved Guideline Procedures for the Handling and Processing of Blood Specimens, H18-A2. 1999. National Committee for Clinical Laboratory Standards. Cembrowski GS, Carey RN. Laboratory quality management: QC QA. ASCP Press, Chicago, IL, 1989. Kricka, L. Interferences in immunoassays still a threat. Clin Chem 2000; 46: 1037. Bjerner J, et al. Immunometric assay interference: incidence and prevention. Clin Chem 2002; 48: 613621. Approved Guideline User evaluation of precision performance of clinical chemistry devices, EP5-A2. 2004. National Committee for Clinical Laboratory Standards, 4(8). Krouwer JS, Rabinowitz R. How to improve estimates of imprecision. Clinical Chemistry, 1984; 30: 290-292. Broome HE, Cembrowski GS, Kahn SN, Martin PL, Patrick CA. Implementation and use of a manual multi-rule quality control procedure. Lab Med 1985; 16: 533-537. Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem 1981; 27: 493-501. Koch DD, Oryall JJ, Quam EF, Feldbruegger DH, et al. Selection of medically useful QC procedures for individual tests done in a multitest analytical system. Clin Chem 1990; 36:230-233. Mugan K, Carlson IH, Westgard JO. Planning QC procedures for immunoassays. J Clin Immunoassay 1994; 17:216-222. Approved Guideline Statistical Quality Control for Quantitative Measurements: Principles and Definitions, C24-A2. February 1999. National Committee for Clinical Laboratory Standards.

Access, SYNCHRON LX, UniCel, DxI and the Beckman Coulter logo are trademarks of Beckman Coulter, Inc. *Lumi-Phos is a trademark of Lumigen, Inc, a subsidiary of Beckman Coulter, Inc. **ProClin is a trademark of Rohm and Haas Company or of its subsidiaries or affiliates. Access Inhibin A Page 14 WB A46221D 2007 Beckman Coulter, Inc.

Manufactured by: Beckman Coulter, Inc. 4300 N. Harbor Blvd. Fullerton, CA 92835 U.S.A.
Printed in U.S.A. Made in U.S.A. Revised November 2007

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Related Interests