7K75-25

en
FSH
ARCHITECT 7K75-20 7K75
FSH 7K75-35 G6-5315 / R11
7K75-30 B7K750
Read Highlighted Changes: Revised January 2016.

Package insert instructions must be carefully followed. Reliability of Abnormal FSH concentrations may also indicate dysfunction of the
assay results cannot be guaranteed if there are any deviations from hypothalamic-pituitary axis. In sexually mature adults, FSH deficiency,
the instructions in this package insert. together with low concentrations of LH and sex steroids, may
indicate panhypopituitarism.7 This can result either from a decrease
ll
NAME in the release of GnRH or from a lack of response of the pituitary
ARCHITECT FSH to GnRH. Determination of serum FSH, following administration of
ll
INTENDED USE GnRH, may allow differentiation of these two conditions.5, 7 The use
The ARCHITECT FSH assay is a Chemiluminescent Microparticle of oral contraceptives usually results in reduction of gonadotropin
Immunoassay (CMIA) for the quantitative determination of follicle levels due to negative feedback by these steroids.5
stimulating hormone (FSH) in human serum and plasma. ll
BIOLOGICAL PRINCIPLES OF THE PROCEDURE
ll
SUMMARY AND EXPLANATION OF THE TEST The ARCHITECT FSH assay is a two-step immunoassay to determine
Human Follicle Stimulating Hormone (FSH, follitropin) is a the presence of FSH in serum and plasma using CMIA technology
glycoprotein of approximately 30,000 daltons which, like luteinizing with flexible assay protocols, referred to as Chemiflex.
hormone (LH, lutropin), human chorionic gonadotropin (hCG) and 1. Sample and anti-β FSH coated paramagnetic microparticles are
thyroid stimulating hormone (TSH, thyrotropin), consists of two combined. The FSH present in the sample binds to the anti-β
noncovalently associated subunits designated α and β.1 The α FSH coated microparticles.
subunit of FSH contains 92 amino acids and is very similar to the α 2. After washing, anti-α FSH acridinium-labeled conjugate is added
subunits of LH, hCG, and TSH.1 The β subunit of FSH is unique and to create a reaction mixture.
confers its immunological and functional specificity.1 3. Following another wash cycle, Pre-Trigger and Trigger Solutions
FSH and LH control growth and reproductive activities of the gonadal are added to the reaction mixture.
tissues.2, 3 FSH promotes follicular development in the ovary and 4. The resulting chemiluminescent reaction is measured as relative
gametogenesis in the testis.3, 4 The gonadotroph cells of the anterior light units (RLUs). There is a direct relationship between the
pituitary secrete both FSH and LH in response to gonadotropin amount of FSH in the sample and the RLUs detected by the
releasing hormone (LHRH or GnRH) from the medial basal ARCHITECT iSystem optics.
hypothalamus.5 Both FSH and LH are secreted in a pulsatile manner, For additional information on system and assay technology, refer to
with rapid fluctuations over the normal range.3, 6, 7 The pulsatility the ARCHITECT System Operations Manual, Section 3.
of FSH is less pronounced than that of LH. Release of both FSH
and LH from the pituitary is under negative feedback control by the ll
REAGENTS
gonads.5 Kit Contents
FSH in mature females acts to stimulate development of the ovarian ARCHITECT FSH 7K75
follicles. Circulating FSH levels vary throughout the menstrual cycle NOTE: Some kit sizes are not available in all countries or for use on
in response to estradiol and progesterone. A small, but significant all ARCHITECT iSystems. Please contact your local distributor.
increase in circulating FSH accompanies the mid-cycle LH surge.
However, the physiological significance of this increase is unknown. 7K75-25 7K75-20 7K75-35 7K75-30
Circulating levels of FSH decline in the luteal phase in response 100 400 500 2000
to estradiol and progesterone production by the developing corpus
luteum.2, 5 1 x 6.6 mL 4 x 6.6 mL 1 x 27.0 mL 4 x 27.0 mL
At menopause, ovarian function is diminished with concomitant 1 x 5.9 mL 4 x 5.9 mL 1 x 26.3 mL 4 x 26.3 mL
decrease in estradiol secretion. FSH and LH then increase
significantly in response to diminished feedback inhibition of  Anti-β FSH (mouse, monoclonal) coated
gonadotropin release.8, 9 In males, FSH, LH, and testosterone Microparticles in MES buffer with protein (murine and caprine)
regulate spermatogenesis by the Sertoli cells in the seminiferous stabilizers. Minimum concentration: 0.1% solids. Preservative:
tubules of the testes. FSH is less sensitive to feedback inhibition by antimicrobial agents.
testosterone than is LH and is thought to be regulated independently  Anti-α FSH (mouse, monoclonal) acridinium-labeled
by the inhibitory peptide inhibin produced by the Sertoli cells.10, 11 Conjugate in MES buffer with protein (bovine) stabilizers. Minimum
Because of the negative feedback mechanisms regulating concentration: 45 ng/mL. Preservative: antimicrobial agents.
gonadotropin release, elevated concentrations of LH and FSH
are indicative of gonadal failure when accompanied by low
concentrations of the gonadal steroids. In males, these observations
suggest primary testicular failure or anorchia.4 FSH may also be
elevated in Klinefelter’s syndrome (seminiferous tubule dysgenesis)
or as a consequence of Sertoli cell failure.4 In females, situations in
which FSH is elevated and gonadal steroids are depressed include
menopause, premature ovarian failure, and ovariectomy, while with
polycystic ovarian syndrome the LH/FSH ratio may be increased.7

1
Other Reagents * Reagents may be stored on or off the ARCHITECT iSystem. If
reagents are removed from the system, store them at 2-8°C (with
1 x 100 mL ARCHITECT Multi-Assay
septums and replacement caps) in an upright position. For reagents
Manual Diluent, 7D82-50, containing phosphate buffered saline
stored off the system, it is recommended that they be stored in
solution. Preservative: antimicrobial agent.
their original trays and boxes to ensure they remain upright. If the
ARCHITECT Pre-Trigger Solution containing microparticle bottle does not remain upright (with a septum
1.32% (w/v) hydrogen peroxide. installed) while in refrigerated storage off the system, the reagent
ARCHITECT Trigger Solution containing 0.35 N kit must be discarded. For information on unloading reagents, refer
sodium hydroxide. to the ARCHITECT System Operations Manual, Section 5.
ARCHITECT Wash Buffer containing phosphate Indications of Reagent Deterioration
buffered saline solution. Preservatives: antimicrobial agents. When a control value is out of the specified range, it may indicate
deterioration of the reagents or errors in technique. Associated test
NOTE: Bottle and volume varies based on order. results are invalid, and samples must be retested. Assay recalibration
Warnings and Precautions may be necessary. For troubleshooting information, refer to the
• ARCHITECT System Operations Manual, Section 10.
• For In Vitro Diagnostic Use ll
INSTRUMENT PROCEDURE
Safety Precautions The ARCHITECT FSH assay file must be installed on the ARCHITECT
CAUTION: This product requires the handling of human specimens. iSystem from an ARCHITECT iSystem Assay CD-ROM prior to
It is recommended that all human-sourced materials be considered performing the assay.
potentially infectious and handled in accordance with the OSHA For detailed information on assay file installation and viewing
Standard on Bloodborne Pathogens. Biosafety Level 2 or other and editing assay parameters, refer to the ARCHITECT System
appropriate biosafety practices should be used for materials that Operations Manual, Section 2.
contain or are suspected of containing infectious agents.12-15 For information on printing assay parameters, refer to the
Safety Data Sheets are available at www.abbottdiagnostics.com or ARCHITECT System Operations Manual, Section 5.
contact your local representative. For a detailed description of system procedures, refer to the
For a detailed discussion of safety precautions during system ARCHITECT System Operations Manual.
operation, refer to the ARCHITECT System Operations Manual, Alternate Result Units
Section 8. Edit assay parameter "Result concentration units" to select an
Reagent Handling alternate unit.
• Do not use reagent kits beyond the expiration date. Conversion formula:
• Do not pool reagents within a kit or between kits. (Concentration in Default result unit) x (Conversion factor) =
• Before loading the reagent kit on the system for the first time, the (Concentration in Alternate result unit)
microparticle bottle requires mixing to resuspend microparticles Default result unit Conversion factor Alternate result unit
that may have settled during shipment. For microparticle mixing mIU/mL 1 IU/L
instructions, refer to the PROCEDURE, Assay Procedure section
of this package insert. ll
SPECIMEN COLLECTION AND PREPARATION
• Septums MUST be used to prevent reagent evaporation and FOR ANALYSIS
contamination and to ensure reagent integrity. Reliability of Specimen Types
assay results cannot be guaranteed if septums are not used
Verified specimen types to be used with this assay:
according to the instructions in this package insert.
• To avoid contamination, wear clean gloves when placing a Specimen Types Collection Tubes
septum on an uncapped reagent bottle. Human serum Serum
• Once a septum has been placed on an open reagent bottle, Serum separator tubes
do not invert the bottle as this will result in reagent leakage Human plasma Lithium heparin
and may compromise assay results. Sodium heparin
• Over time, residual liquids may dry on the septum surface. Potassium EDTA
These are typically dried salts and have no effect on assay
• Other anticoagulants have not been validated for use with the
efficacy.
ARCHITECT FSH assay.
For a detailed discussion of handling precautions during system
• The instrument does not provide the capability to verify specimen
operation, refer to the ARCHITECT System Operations Manual,
type. It is the responsibility of the operator to verify that the
Section 7.
correct specimen types are used in the assay.
Reagent Storage
Specimen Conditions
When stored and handled as directed, reagents are stable until the
• For optimal results, serum and plasma specimens should be free
expiration date.
of fibrin, red blood cells or other particulate matter.
Storage Maximum Additional Storage
Temperature Storage Time Instructions
• Ensure that complete clot formation in serum specimens has
taken place prior to centrifugation. Some specimens, especially
Unopened/ 2-8°C Until May be used immediately
those from patients receiving anticoagulant or thrombolytic
Opened* expiration after removal from 2-8°C
therapy, may exhibit increased clotting time. If the specimen is
date storage.
centrifuged before a complete clot forms, the presence of fibrin
Store in upright position. may cause erroneous results.
On board System 30 days Discard after 30 days. • To prevent cross contamination, use of disposable pipettes or
temperature For information on tracking pipette tips is recommended.
onboard time, refer to
the ARCHITECT System
Operations Manual,
Section 5.

2
Preparation for Analysis • Load the reagent kit on the ARCHITECT iSystem.
• Follow the tube manufacturer’s processing instructions for • Verify that all necessary reagents are present.
specimen collection tubes. • Ensure that septums are present on all reagent bottles.
• Specimens must be mixed THOROUGHLY after thawing, by LOW • Order calibration, if necessary.
speed vortexing or by gently inverting, and centrifuged prior to • For information on ordering calibrations, refer to the
use to remove red blood cells or particulate matter to ensure ARCHITECT System Operations Manual, Section 6.
consistency in the results. • Order tests.
• Inspect all specimens for bubbles. Remove bubbles with an • For information on ordering patient specimens and
applicator stick before analysis. Use a new applicator stick for controls and for general operating procedures, refer to the
each specimen to prevent cross contamination. ARCHITECT System Operations Manual, Section 5.
Specimen Storage • Minimum sample cup volume is calculated by the system
Specimen Type Storage Temperature Maximum Storage Time and printed on the Orderlist report. To minimize the effects of
Serum/Plasma 2-8°C ≤ 7 days evaporation, verify adequate sample cup volume is present prior
to running the test.
If testing will be delayed more than 24 hours, remove serum or Maximum number of replicates sampled from the same sample
plasma from the clot, serum separator or red blood cells. Specimens cup: 10
may be stored for up to 7 days at 2-8°C prior to being tested. • Priority:
If testing will be delayed more than 7 days, specimens should be Sample volume for first test: 75 µL
frozen at -10°C or colder. Specimens stored frozen at -10°C or colder
Sample volume for each additional test from same sample
for 12 months showed no performance difference.
cup: 25 µL
Avoid multiple freeze/thaw cycles.
• ≤ 3 hours on board:
Specimen Shipping Sample volume for first test: 150 µL
• Package and label specimens in compliance with applicable Sample volume for each additional test from same sample
state, federal, and international regulations covering the transport
cup: 25 µL
of clinical specimens and infectious substances.
• > 3 hours on board: Additional sample volume is required.
• Do not exceed the storage limitations listed above.
Refer to the ARCHITECT System Operations Manual, Section
ll
PROCEDURE 5 for information on sample evaporation and volumes.
Materials Provided • If using primary or aliquot tubes, use the sample gauge to
ensure sufficient patient specimen is present.
7K75 ARCHITECT FSH Reagent Kit
• Prepare ARCHITECT FSH Calibrators and Controls.
Materials Required but not Provided • Mix calibrator(s) and controls by gentle inversion before use.
• ARCHITECT FSH Assay file obtained from the ARCHITECT
• Hold bottles vertically and dispense recommended volumes
iSystem e-Assay CD-ROM found on www.abbottdiagnostics.com.
into each respective sample cup.
• 7K75-01 ARCHITECT FSH Calibrators
• Recommended volumes:
• 7K75-10 ARCHITECT FSH Controls
for each calibrator: 4 drops
• 7D82-50 ARCHITECT Multi-Assay Manual Diluent
for each control: 3 drops
• ARCHITECT Pre-Trigger Solution
• Load samples.
• ARCHITECT Trigger Solution
• For information on loading samples, refer to the ARCHITECT
• ARCHITECT Wash Buffer
System Operations Manual, Section 5.
• ARCHITECT Reaction Vessels
• Press RUN.
• ARCHITECT Sample Cups
• For additional information on principles of operation, refer to the
• ARCHITECT Septum ARCHITECT System Operations Manual, Section 3.
• ARCHITECT Replacement Caps • For optimal performance, it is important to perform routine
• Pipettes or pipette tips (optional) to deliver the volumes specified maintenance as described in the ARCHITECT System Operations
on the patient or control order screen. Manual, Section 9. Perform maintenance more frequently when
For information on materials required for maintenance procedures, required by laboratory procedures.
refer to the ARCHITECT System Operations Manual, Section 9.
Specimen Dilution Procedures
Assay Procedure Specimens with an FSH value exceeding 150.00 mIU/mL are flagged
• Before loading the reagent kit on the system for the first time, the with the code “ >150.00” and may be diluted using either the
microparticle bottle requires mixing to resuspend microparticles Automated Dilution Protocol or the Manual Dilution Procedure.
that may have settled during shipment. After the first time the Automated Dilution Protocol
microparticles have been loaded, no further mixing is required. The system performs a 1:5 dilution of the specimen and
• Invert the microparticle bottle 30 times. automatically calculates the concentration of the specimen before
• Visually inspect the bottle to ensure microparticles are dilution and reports the result.
resuspended. If microparticles are still adhered to the bottle,
continue to invert the bottle until the microparticles have
been completely resuspended.
• If the microparticles do not resuspend, DO NOT USE.
Contact your local Abbott representative.
• Once the microparticles have been resuspended, place a
septum on the bottle. For instructions about placing septums
on bottles, refer to the Reagent Handling section of this
package insert.

3
Manual Dilution Procedure • Heterophilic antibodies in human serum can react with reagent
Suggested dilution: 1:5 immunoglobulins, interfering with in vitro immunoassays. Patients
It is recommended that dilutions not exceed 1:5. routinely exposed to animals or to animal serum products can
be prone to this interference, and anomalous values may be
1. Add 20 μL of the patient specimen to 80 μL of ARCHITECT
observed. Additional information may be required for diagnosis.18
Multi-Assay Manual Diluent (7D82-50).
2. The operator must enter the dilution factor in the Patient or ll
EXPECTED VALUES
Control order screen. The system will use this dilution factor The suggested normal range for the ARCHITECT FSH assay
to automatically calculate the concentration of the sample represents the FSH values obtained from 150 normal males, 34
before dilution and report the result. The result should be post-menopausal females (not on hormone replacement therapy)
> 0.25 mIU/mL before the dilution factor is applied. and 44 normal cycling females. For this study, the follicular phase
3. If the operator does not enter the dilution factor, the reported was defined as the period of time from 10 to 4 days prior to the
result will be that of the diluted sample. This result should be mid-cycle peak. The luteal phase was defined as the period of time
> 0.25 mIU/mL. from 4 to 10 days following the mid-cycle peak. Cycle days were
For detailed information on ordering dilutions, refer to the ARCHITECT synchronized to the mid-cycle peak (the day when LH values are
System Operations Manual, Section 5. most elevated). The results are presented in the following table.
(NOTE: 44 women participated in the study for serial blood draws.
Calibration At the time of testing for ARCHITECT FSH, only 42 of the mid-cycle
• Test Calibrators 1 and 2 in duplicate. The calibrators should be samples were available for testing. Samples from all 44 women were
priority loaded. included in the Follicular and Luteal Phase expected values testing.)
A single sample of each control level must be tested to evaluate
FSH Value (mIU/mL)
the assay calibration. Ensure that assay control values are within
Range (central
the ranges specified in the respective control package insert. n Mean 95 %)
• Calibration Range: 0.00 - 150.00 mIU/mL. Males 150 3.37 0.95 - 11.95
• Once an ARCHITECT FSH calibration is accepted and stored, all Normally Menstruating Females
subsequent samples may be tested without further calibration Follicular Phase 144 4.95 3.03 - 8.08
unless: Mid-Cycle Peak 42 9.62 2.55 - 16.69
• A reagent kit with a new lot number is used or Luteal Phase 138 2.75 1.38 - 5.47
• Controls are out of range. Post-menopausal Females 34 59.71 26.72 - 133.41
• For detailed information on how to perform an assay calibration, It is recommended that each laboratory establish its own reference
refer to the ARCHITECT System Operations Manual, Section 6. range that is appropriate for the laboratory’s patient population (i.e.,
Quality Control Procedures a normal range that reflects the type of specimen and demographic
The recommended control requirement for the ARCHITECT FSH variables such as age and sex, as applicable).
assay is that a single sample of each control level be tested once
every 24 hours each day of use. If the quality control procedures in
ll
SPECIFIC PERFORMANCE CHARACTERISTICS
your laboratory require more frequent use of controls to verify test Precision
results, follow your laboratory-specific procedures. The ARCHITECT FSH Assay is designed to have a total CV of
Ensure that assay control values are within the concentration ranges ≤ 10% for concentrations in the range of the Low, Medium and High
specified in the package insert. Controls. Precision was determined as described in Clinical and
Verification of Assay Claims Laboratory Standards Institute (CLSI, formerly NCCLS) Protocol
EP5-T2.19 A three member calf serum based panel was assayed,
For protocols to verify package insert claims, refer to the ARCHITECT
using two lots of reagents, on two instruments, in replicates of two
System Operations Manual, Appendix B.
at two separate times per day for 20 days. Data from this study are
The ARCHITECT FSH assay belongs to method group 1. summarized in the following table.
ll
RESULTS Panel Reagent Mean Conc. Within Run Total
The ARCHITECT FSH assay utilizes a 4 Parameter Logistic Curve fit Member Lot Instrument n (mIU/mL) SD %CV SD %CV
data reduction method (4PLC, Y-weighted) to generate a calibration 1 1 1 80 5.08 0.143 2.8 0.181 3.6
curve. 1 1 2 80 5.16 0.171 3.3 0.217 4.2
For information on alternate result units, refer to the INSTRUMENT 1 2 1 80 5.55 0.156 2.8 0.204 3.7
PROCEDURE, Alternate Result Units section of this package insert. 1 2 2 80 5.64 0.239 4.2 0.262 4.6
Flags 2 1 1 80 25.09 0.686 2.7 0.965 3.8
Some results may contain information in the Flags field. For a 2 1 2 80 24.95 0.715 2.9 0.895 3.6
description of the flags that may appear in this field, refer to the 2 2 1 80 26.83 0.727 2.7 0.868 3.2
ARCHITECT System Operations Manual, Section 5. 2 2 2 80 26.98 0.767 2.8 1.103 4.1
3 1 1 80 74.72 2.080 2.8 3.027 4.1
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LIMITATIONS OF THE PROCEDURE 3 1 2 80 72.35 1.864 2.6 2.419 3.3
• For diagnostic purposes, results should be used in conjunction
3 2 1 80 78.12 2.554 3.3 3.211 4.1
with other data; e.g., symptoms, results of other tests, clinical
3 2 2 80 76.54 2.311 3.0 2.582 3.4
impressions, etc.
• If the FSH results are inconsistent with clinical evidence, Accuracy by Recovery
additional testing is suggested to confirm the result. Accuracy by recovery of this assay was designed to be ± 15% of
• Specimens from patients who have received preparations of spike level. Known concentrations of World Health Organization
mouse monoclonal antibodies for diagnosis or therapy may (WHO) 1st International Standard (IS) FSH 92/510 were added to 11
contain human anti-mouse antibodies (HAMA). Such specimens aliquots of human serum at 2 concentration levels (20 mIU/mL and
may show either falsely elevated or depressed values when 40 mIU/mL). The concentration of FSH was determined using the
tested with assay kits such as ARCHITECT FSH that employ ARCHITECT FSH assay. The mean recovery of WHO 1st IS FSH is
mouse monoclonal antibodies. Additional information may be 96.05%.
required for diagnosis.16, 17

4
Analytical Sensitivity ll
BIBLIOGRAPHY
The analytical sensitivity of the ARCHITECT FSH assay was 1. Pierce JG, Parsons TF. Glycoprotein Hormones: Structure and
calculated to be better than 0.05 mIU/mL (n = 36 runs). Analytical Function. Annu Rev Biochem 1981:50:465-495.
sensitivity is defined as the concentration at two standard deviations 2. Daughaday WH. The Adenohypophysis. In: Wilson JD, Foster DW,
from the ARCHITECT FSH MasterCheck Level 0 (0.00 mIU/mL), and editors. Williams Textbook of Endocrinology. Philadelphia: Saunders,
1985:568-613.
represents the lowest measurable concentration of FSH that can be
3. Catt KJ, Pierce JG. Gonadotropic Hormones of the Adenohypophysis.
distinguished from zero. In: Yen SSC and Jaffe RB editors. Reproductive Endocrinology.
Specificity Philadelphia: Saunders, 1978:34-62.
The specificity of the ARCHITECT FSH assay was determined 4. Franchimont P. Human Gonadotropin Secretion in Male Subjects. In:
James VHT, Serio M and Martini L, editors. The Endocrine Function
by studying the cross-reactivity of LH, TSH, and hCG. Aliquots of of the Human Testis. New York: Academic Press, 1973:439-458.
processed bovine serum were supplemented with 250 mIU/mL LH, 5. Bonnar J. Gynaecology and Obstetrics: The Hypothalamus and
100 μIU/mL TSH, and 200,000 mIU/mL hCG and assayed for FSH. Reproductive Function. In: Scott RB and Walker RM, editors. The
The cross-reactivity was calculated as a percent cross-reactivity and Medical Annual. Bristol (England): J Wright and Sons, 1973:251-258.
was shown to be 0.002% for LH, 0.043% for TSH and 0.001% for 6. Crowley WF Jr, Filicori M, Santoro NF. GnRH Secretion Across the
hCG. Normal Menstrual Cycle. In: Crowley WF Jr and Holfler JG, editors.
The Episodic Secretion of Hormones. New York: John Wiley and
Interference Sons, 1987:219-231.
Potential interference from hemoglobin, bilirubin, triglycerides, and 7. Beastall GH, et al. Assays for Follicle Stimulating Hormone and
protein was studied in the ARCHITECT FSH assay. The ARCHITECT Luteinizing Hormone: Guidelines for the Provision of a Clinical
FSH assay demonstrated the following interferences. Biochemistry Service. Ann Clin Biochem 1987;24:246-262.
8. Judd HL. Hormonal Dynamics Associated with the Menopause. Clin
• Hemoglobin ≤ 10% at 500 mg/dL Obstet Gynecol 1976;19:775-788.
• Bilirubin ≤ 10% at 20 mg/dL 9. Ross GT. Disorders of the Ovary and Female Reproductive Tract. In:
• Triglycerides ≤ 10% at 3000 mg/dL Wilson JD, Foster DW, editors. Williams Textbook of Endocrinology.
• Protein ≤ 10% at 2 g/dL and 12 g/dL Philadelphia: WB Saunders Co. 1985:206-258.
10. Jeffcoate SL. The Control of Testicular Function in the Adult. Clinics
in Endocrinology and Metabolism 1975;4:521-543.
Correlation 11. Griffin JE, Wilson JD. Disorders of the Testes and Male Reproductive
The ARCHITECT FSH assay was compared to the AxSYM FSH Tract. In: Wilson JD, and Foster DW, editors. Williams Textbook of
assay. The result of the specimen testing is shown in the following Endocrinology. Philadelphia: W. B. Saunders, Co., 1985;259-311.
table.** 12. US Department of Labor, Occupational Safety and Health
Abbott ARCHITECT FSH vs. Abbott AxSYM FSH Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
Number of Correlation 13. US Department of Health and Human Services. Biosafety in
Method Specimens Intercept Slope Coefficient Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
US Government Printing Office; December 2009.
Least Squares Linear 627 -0.09 1.02 0.99
14. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
Regression
Geneva: World Health Organization; 2004.
Passing-Bablok Linear 627 -0.12 1.03 0.99 15. Clinical and Laboratory Standards Institute (CLSI). Protection
Regression* of Laboratory Workers From Occupationally Acquired Infections;
In this evaluation, serum specimens ranged from 0.46 to Approved Guideline—Fourth Edition. CLSI Document M29-A4. Wayne,
PA: CLSI; 2014.
120.45 mIU/mL with the ARCHITECT FSH assay. 16. Primus FJ, Kelley EA, Hansen HJ, et al. “Sandwich”-type
* A linear regression method with no special assumptions regarding immunoassay of carcinoembryonic antigen in patients receiving
the distribution of the samples and measurement errors.20 murine monoclonal antibodies for diagnosis and therapy. Clin Chem
** Representative data; variables such as differences in sampling 1988;34(2):261-264.
size and sample population may impact the correlation of the assay; 17. Schroff RW, Foon KA, Beatty SM, et al. Human anti-murine
immunoglobulin responses in patients receiving monoclonal antibody
therefore, results in individual laboratories may vary from these data.
therapy. Cancer Res 1985;45(2):879-885.
18. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all
immunoassays. Clin Chem 1988;34(1):27-33.
19. National Committee for Clinical Laboratory Standards (NCCLS).
Evaluation of Precision Performance of Clinical Chemistry Devices;
Tentative Guideline—Second Edition. NCCLS Document EP5-T2.
Villanova, PA: NCCLS; 1992.
20. Passing HA, Bablok W. A new biometrical procedure for testing the
equality of measurements from two different analytical methods. J
Clin Chem Clin Biochem 1983;21:709-720.

5
ll
Key to Symbols
Consult instructions for use

Manufacturer

Sufficient for

Temperature limitation

Use by/Expiration date

Conjugate
Control Number
Distributed in the USA by
Information needed for United
States of America only
In Vitro Diagnostic Medical
Device
Lot Number
Microparticles
Multi-Assay Manual Diluent
Product of Ireland
Pre-Trigger Solution
Reaction Vessels
Reagent Lot
List Number
Replacement Caps
Sample Cups
Septum
Serial number
Trigger Solution
Wash Buffer

ARCHITECT, AxSYM, MasterCheck, and Chemiflex are trademarks of

Abbott Ireland
Diagnostics Division
Lisnamuck, Longford
Co. Longford
Ireland
+353-43-3331000

Abbott Laboratories
Abbott Park, IL 60064 USA
Customer Service: Contact your local representative
or find country-specific contact information on
www.abbottdiagnostics.com
Revised January 2016.
©2006, 2016 Abbott Laboratories