en LH

system
2P40
G3-0641/R04
B2P400
Read Highlighted Changes
Revised October 2012

LH
Customer Service: Contact your local representative or find country-specific contact information
on www.abbottdiagnostics.com
Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any
deviations from the instructions in this package insert.

Key to symbols used

List Number Reagent Lot
In Vitro Diagnostic Medical
Control Number
Device

Lot Number Reaction Vessels

Sample Cups
Serial Number

Septum
Expiration Date
Replacement Caps
Store at 2-8°C
Warning: May cause
an allergic reaction
Caution Global Trade Item
Number

Consult instructions for use Product of Ireland

Information needed for

Manufacturer United States of
America only

See REAGENTS section for a full explanation of symbols used in reagent

component naming.

1
NAME REAGENTS
ARCHITECT LH Reagent Kit, 100 Tests/500 Tests
INTENDED USE NOTE: Some kit sizes are not available in all countries or for use on all
ARCHITECT i Systems. Please contact you local distributor.
The ARCHITECT LH assay is a chemiluminescent microparticle
immunoassay (CMIA) for the quantitative determination of human ARCHITECT LH Reagent Kit (2P40)
luteinizing hormone (LH) in human serum and plasma. • 1 Bottle (6.6 mL per 100-test bottle/27.0 mL per
500-test bottle) Anti-ß LH (mouse, monoclonal) antibody coated
SUMMARY AND EXPLANATION OF TEST microparticles in HEPES buffer with protein (bovine, mouse) stabilizers.
Human luteinizing hormone (LH, lutropin) is a glycoprotein hormone with Minimum concentration: 0.04% solids. Preservative: ProClin 300.
two dissimilar subunits (α and β). The α-subunit is essentially identical • 1 Bottle (5.9 mL per 100-test bottle/26.3 mL per
to the α-subunits of follicle stimulating hormone (FSH, follitropin), thyroid 500-test bottle) Anti-α LH (mouse, monoclonal) acridinium-labeled
stimulating hormone (TSH, thyrotropin), and human chorionic gonadotropin conjugate in MES buffer with protein (bovine, casein) stabilizers.
(hCG).1-4 The β-subunit is considerably different from that of FSH and Minimum concentration: 170 ng/mL. Preservatives: ProClin 300 and
TSH.1,4,5 However, the β-subunits of LH and hCG are very similar.1,5,6 ProClin 950.
LH, together with FSH, is secreted by the gonadotroph cells in the
pituitary5,7 in response to the secretion of the gonadotropin releasing Assay Diluent
hormone (LHRH, GnRH) from the medial basal hypothalamus.8-10 Ovarian ARCHITECT i Multi-Assay Manual Diluent (7D82-50)
steroids, principally estrogens, modulate the secretion of LH and FSH • 1 Bottle (100 mL) ARCHITECT
which in turn regulate the menstrual cycle in females. When the follicle i Multi-Assay Manual Diluent containing phosphate buffered saline
and the ovum contained within it, reach maturity, a surge of LH causes the solution. Preservative: antimicrobial agent.
follicle to rupture releasing the ovum. The follicular remnant is transformed Other Reagents
into a corpus luteum, which secretes progesterone and estradiol. During
ARCHITECT i Pre-Trigger Solution
the follicular and luteal phases, LH concentrations are much lower than
the levels observed at the time of the LH surge. During the follicular and • Pre-Trigger Solution containing 1.32% (w/v)
luteal phases, the estrogens exert a negative feedback on the release of hydrogen peroxide.
LH. Shortly before the mid-cycle surge in LH, ovarian steroids, specifically ARCHITECT i Trigger Solution
estradiol, exert a positive feedback on the release of LH.11-13 • Trigger solution containing 0.35 N sodium
Determination of the concentration of LH is essential for the prediction of hydroxide.
ovulation, in the evaluation of infertility, and the diagnosis of pituitary and ARCHITECT i Wash Buffer
gonadal disorders.11,14 Increasing concentrations of LH precede ovulation • Wash buffer containing phosphate buffered saline
and in cases in which the period of optimal fertility needs to be defined for solution. Preservatives: antimicrobial agents.
the timing of intercourse or artificial insemination, daily concentrations of
LH are important for the prediction of ovulation. More frequent sampling is WARNINGS AND PRECAUTIONS
required if the precise time of follicular rupture is needed for egg aspiration •
for in vitro fertilization.15 • For In Vitro Diagnostic Use
At menopause, or following ovariectomy in women, concentrations of • Package insert instructions must be carefully followed. Reliability of
estrogens decline to low levels. The lowered concentrations of estrogens assay results cannot be guaranteed if there are any deviations from
result in a loss of the negative feedback on gonadotropin release. the instructions in this package insert.
The consequence is an increase in the concentrations of LH and Safety Precautions
FSH.11,15,16 • CAUTION: This product requires the handling of human specimens.
The primary role of LH in the male is to stimulate the production of It is recommended that all human sourced materials be considered
testosterone by the Leydig cells. LH, through the production of testosterone potentially infectious and handled in accordance with the OSHA
together with FSH, regulates spermatogenesis in the Sertoli cells of Standard on Bloodborne Pathogens.21 Biosafety Level 222 or other
the seminiferous tubules of the testes. Testosterone exerts a negative appropriate biosafety practices23,24 should be used for materials that
feedback on the release of LH.14 contain or are suspected of containing infectious agents.
In sexually mature adults, gonadotropin deficiency is usually an early • The following warnings and precautions apply to these components:
indication of the development of panhypopituitarism. Low concentrations • Microparticles
of LH, FSH, and steroids are observed with this disorder. In contrast,
• Conjugate
gonadotropin secreting tumors of the hypothalamus and pituitary result in
elevated concentrations of LH and FSH.15 WARNING: Contains methylisothiazolones.
Gonadal failure, a cause of infertility, is indicated by elevated H317 May cause an allergic skin reaction.
concentrations of LH and FSH accompanied by low concentrations of
gonadal steroids.11,14,15 In the female, elevated concentrations of LH Prevention
can indicate primary amenorrhea,11 menopause,11,15,16 premature P261 Avoid breathing mist/vapours/spray.
ovarian failure,15,17 polycystic ovarian syndrome,17,18 hypergonadotropic P272 Contaminated work clothing should not be
hypogonadism,11,15 or ovulation. In the male, elevated concentrations allowed out of the workplace.
of LH can result from primary testicular failure, seminiferous tubule P280 Wear protective gloves/
dysgenesis (Klinefelter’s syndrome), Sertoli cell failure, anorchia, or protective clothing/eye protection.
hypergonadotropic hypogonadism.19,20
BIOLOGICAL PRINCIPLES OF THE PROCEDURE Response
The ARCHITECT LH assay is a two-step immunoassay for the quantitative P302+P352 IF ON SKIN: Wash with plenty of water.
determination of luteinizing hormone (LH) in human serum and plasma P333+P313 If skin irritation or rash occurs: Get
using Chemiluminescent Microparticle Immunoassay (CMIA) technology medical advice/attention.
with flexible assay protocols, referred to as Chemiflex. P363 Wash contaminated clothing before reuse.
In the first step, sample and anti-β LH coated paramagnetic microparticles This material and its container must be disposed of in
are combined. LH present in the sample binds to the anti-β LH coated a safe way.
microparticles. After washing, anti-α LH acridinium-labeled conjugate is
added to create a reaction mixture in the second step. Following another • Safety Data Sheets are available at www.abbottdiagnostics.com or
wash cycle, pre-trigger and trigger solutions are added to the reaction contact your local representative.
mixture. The resulting chemiluminescent reaction is measured as relative • For a detailed discussion of safety precautions during system
light units (RLUs). A direct relationship exists between the amount of LH in operation, refer to the ARCHITECT System Operations Manual,
the sample and the RLUs detected by the ARCHITECT i System optics. Section 8.
For additional information on system and assay technology refer to the
ARCHITECT System Operations Manual, Section 3.

2
Handling Precautions SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS
• Do not use reagent kits beyond the expiration date. Specimen Types
• Do not pool reagents within a kit or between reagent kits. The specimen collection tubes listed below were verified for use with the
• Before loading the ARCHITECT LH Reagent Kit on the system for ARCHITECT LH assay. Other specimen collection tubes have not been
the first time, the microparticle bottle requires mixing to resuspend tested with this assay.
microparticles that have settled during shipment. For microparticle • Human serum (including serum collected in serum separator tubes)
mixing instructions, refer to the PROCEDURE, Assay Procedure • Human plasma collected in:
section of this package insert. • Potassium-EDTA
• Septums MUST be used to prevent reagent evaporation and • Sodium-Heparin
contamination and to ensure reagent integrity. Reliability of assay
• Liquid anticoagulants may have a dilution effect resulting in lower
results cannot be guaranteed if septums are not used according to
concentrations for individual patient specimens.
the instructions in this package insert.
• The ARCHITECT i System does not provide the capability to verify
• To avoid contamination, wear clean gloves when placing a septum on
specimen type. It is the responsibility of the operator to verify that the
an uncapped reagent bottle.
correct specimen types are used in the ARCHITECT LH assay.
• Once a septum has been placed on the reagent bottle, do not
invert the bottle as this will result in reagent leakage and may Specimen Conditions
compromise assay results. • Do not use specimens with the following conditions:
• Over time, residual liquids may dry on the septum surface. These • heat-inactivated
are typically dried salts, which have no effect on assay efficacy. • pooled
• For a detailed discussion of handling precautions during system • grossly hemolyzed (> 500 mg/dL hemoglobin)
operation, refer to the ARCHITECT System Operations Manual, • obvious microbial contamination
Section 7. • cadaver specimens or any other body fluids
Storage Instructions • For accurate results, serum and plasma specimens should be free of
fibrin, red blood cells, and other particulate matter. Serum specimens
from patients receiving anticoagulant or thrombolytic therapy may
• The ARCHITECT LH Reagent Kit must be stored at 2-8°C contain fibrin due to incomplete clot formation.
in an upright position and may be used immediately after removal • Use caution when handling patient specimens to prevent cross
from 2-8°C storage. contamination. Use of disposable pipettes or pipette tips is
• When stored and handled as directed, reagents are stable until the recommended.
expiration date. • For optimal results, inspect all specimens for bubbles. Remove bubbles
• The ARCHITECT LH Reagent Kit may be stored on board the with an applicator stick before analysis. Use a new applicator stick for
ARCHITECT i System for a maximum of 30 days. After 30 days, the each specimen to prevent cross contamination.
reagent kit must be discarded. For information on tracking onboard
time, refer to the ARCHITECT System Operations Manual, Section 5. Preparation for Analysis
• Reagents may be stored on or off the ARCHITECT i System. If reagents • Follow the tube manufacturer’s processing instructions for serum
are removed from the system, store them at 2-8°C (with septums and and plasma collection tubes. Gravity separation is not sufficient for
replacement caps) in an upright position. For reagents stored off the specimen preparation.
system, it is recommended that they be stored in their original trays and • Mix thawed specimens thoroughly by low speed vortexing or by
boxes to ensure they remain upright. If the microparticle bottle does inverting 10 times. Visually inspect the specimens. If layering or
not remain upright (with a septum installed) while in refrigerated stratification is observed, continue mixing until specimens are visibly
storage off the system, the reagent kit must be discarded. For homogeneous.
information on unloading reagents, refer to the ARCHITECT System • To ensure consistency in results, specimens must be transferred to a
Operations Manual, Section 5. centrifuge tube and centrifuged at ≥ 10000 RCF (Relative Centrifugal
Force) for 10 minutes before testing if
Indications of Reagent Deterioration
• they contain fibrin, red blood cells, or other particulate matter,
When a control value is out of the specified range, it may indicate
deterioration of the reagents or errors in technique. Associated test • they require repeat testing, or
results are invalid and samples must be retested. Assay recalibration may • they were frozen and thawed.
be necessary. For troubleshooting information, refer to the ARCHITECT Transfer clarified specimen to a sample cup or secondary tube for
System Operations Manual, Section 10. testing.
INSTRUMENT PROCEDURE • Centrifuged specimens with a lipid layer on the top must be transferred
• The ARCHITECT LH assay file must be installed on the ARCHITECT to a sample cup or secondary tube. Care must be taken to transfer
i System from an ARCHITECT i System Assay CD-ROM. only the clarified specimen without the lipemic material.
• For detailed information on assay file installation and on viewing and Storage
editing assay parameters, refer to the ARCHITECT System Operations If testing will be delayed more than 24 hours, remove serum or plasma
Manual, Section 2. from the clot, red blood cells, or separator gel. Specimens may be stored
• For information on printing assay parameters, refer to the ARCHITECT for up to 7 days refrigerated at 2-8°C prior to being tested. If testing will
System Operations Manual, Section 5. be delayed more than 7 days, store frozen (< - 10°C).
• For a detailed description of system procedures, refer to the Specimens that encountered three freeze/thaw cycles showed no
ARCHITECT System Operations Manual. performance difference. Avoid multiple freeze/thaw cycles.
• The default result unit for the ARCHITECT LH assay is mIU/mL. An Shipping
alternate result unit, IU/L, may be selected for reporting results by • Before shipping specimens, it is recommended that specimens be
editing assay parameter “Result units” to IU/L. The conversion factor removed from the clot, red blood cells, or separator gel.
used by the system is 1. • When shipping specimens, package and label specimens in compliance
with applicable state, federal, and international regulations covering
the transport of clinical specimens and infectious substances.
• Specimens may be shipped thermally controlled refrigerated or frozen
on dry ice. Do not exceed the storage time limitations listed above.

3
PROCEDURE • Load samples.
Materials Provided • For information on loading samples, refer to the ARCHITECT
• 2P40 ARCHITECT LH Reagent Kit System Operations Manual, Section 5.
Materials Required but not Provided • Press RUN.
• ARCHITECT i System • For additional information on principles of operation, refer to the
ARCHITECT Operations Manual, Section 3.
• ARCHITECT LH assay file, obtained from the
• For optimal performance, it is important to perform routine maintenance
• ARCHITECT i System e-Assay CD-ROM found on
as described in the ARCHITECT System Operations Manual, Section 9.
www.abbottdiagnostics.com or Perform maintenance more frequently when required by laboratory
• ARCHITECT i System Assay CD-ROM procedures.
• 2P40-01 ARCHITECT LH Calibrators
Specimen Dilution Procedures
• Abbott Immunoassay-MCC (Liquid) or other control material Specimens with a LH concentration of > 250.00 mIU/mL (> 250.00 IU/L)
• 7D82-50 ARCHITECT i will be flagged as “>250.00” and may be diluted with either the Automated
• ARCHITECT i Dilution Protocol or the Manual Dilution Procedure.
• ARCHITECT i • Only specimens with a concentration of greater than 2.00 mIU/mL
• ARCHITECT i (2.00 IU/L) should be diluted.
• ARCHITECT i • If using the Automated Dilution Protocol, the system performs
• ARCHITECT i a 1:4 dilution of the specimen and automatically calculates the
• ARCHITECT i concentration of the specimen before dilution and reports the result.
Specimens exceeding 1000.00 mIU/mL (1000.00 IU/L) are flagged
• ARCHITECT i with the code “>1000.00” when run using the Automated Dilution
• Pipettes or pipette tips (optional) Protocol.
For information on materials required for maintenance procedures, refer to • Manual dilutions should be performed as follows:
the ARCHITECT System Operations Manual, Section 9. • The suggested dilution for the ARCHITECT LH assay is 1:4. It is
Assay Procedure recommended not to exceed a 1:4 dilution.
• Before loading the ARCHITECT LH Reagent Kit on the system for • Add 40 μL of the patient specimen to 120 μL of ARCHITECT
the first time, the microparticle bottle requires mixing to resuspend i Multi-Assay Manual Diluent.
microparticles that have settled during shipment. After the first time • The operator must enter the dilution factor in the Patient or
the microparticles have been loaded, no further mixing is required. Control order screen. The system will use this dilution factor to
• Invert the microparticle bottle 30 times. automatically calculate the concentration of the sample before
• Visually inspect the bottle to ensure microparticles are dilution and report the result.
resuspended. If microparticles remain adhered to the bottle, • For detailed information on ordering dilutions, refer to the ARCHITECT
continue inverting the bottle until the microparticles have been System Operations Manual, Section 5.
completely resuspended.
Calibration
• If the microparticles do not resuspend, DO NOT USE. Contact • To perform an ARCHITECT LH calibration, test calibrators A, B, C, D, E,
your local Abbott representative. and F in duplicate. Calibrators should be priority loaded. To evaluate
• Once the microparticles have been resuspended, place a septum the calibration of this assay using commercially available controls, a
on the bottle. For instructions on placing septums on bottles refer single sample of all levels of controls should be tested to evaluate
to the Handling Precautions section of this package insert. the assay calibration. Ensure that assay control values are within the
• Load the ARCHITECT LH Reagent Kit on the ARCHITECT i System. established ranges.
• Verify that all necessary assay reagents are present. • Calibration Range: 0.00 - 250.00 mIU/mL (0.00 – 250.00 IU/L).
• Ensure that septums are present on all reagent bottles. • Once an ARCHITECT LH calibration is accepted and stored, all
• Order calibration, if necessary. subsequent samples may be tested without further calibration
• For information on ordering calibrations, refer to the ARCHITECT unless:
System Operations Manual, Section 6. • A reagent kit with a new lot number is used.
• Order tests. • Controls are out of range.
• For information on ordering patient specimens and controls and • For detailed information on how to perform an assay calibration, refer
for general operating procedures, refer to the ARCHITECT System to the ARCHITECT System Operations Manual, Section 6.
Operations Manual, Section 5.
QUALITY CONTROL PROCEDURES
• The minimum sample cup volume is calculated by the system and Additional controls may be tested in conformance with local, state,
is printed on the Orderlist report. No more than 10 replicates may and/or federal regulations or accreditation requirements and your
be sampled from the same sample cup. To minimize the effects of laboratories quality control policy. Each laboratory should establish control
evaporation, verify adequate sample cup volume is present before ranges to monitor the acceptable performance of the assay.
running the test.
If a control is out of its specified range, the associated test results are
• Priority: 75 μL for the first ARCHITECT LH test plus 25 μL for each invalid and samples must be retested. Recalibration may be indicated.
additional ARCHITECT LH test from the same sample cup.
Laboratories should establish their own concentration ranges for new control
• ≤ 3 hours on board: 150 μL for the first ARCHITECT LH test plus lots at each clinically relevant control level. This can be accomplished by
25 μL for each additional ARCHITECT LH test from the same assaying a minimum of 20 replicates over several (3-5) days. Sources of
sample cup. variation that can be expected should be included in this study in order to
• > 3 hours on board: additional sample volume is required. For be representative of future system performance. These may include:
information on sample evaporation and volumes, refer to the • Multiple stored calibrations
ARCHITECT System Operations Manual, Section 5.
• Multiple reagent lots
• If using primary or aliquot tubes, use the sample gauge to ensure
• Multiple calibrator lots
sufficient patient specimen is present.
• Multiple processing modules
• Prepare calibrators.
• Data points collected at different times of the day
• Mix ARCHITECT LH Calibrators by gentle inversion before use.
• To obtain the recommended volume requirements for the
ARCHITECT LH Calibrators, hold the bottles vertically and
dispense 4 drops of each calibrator into each respective sample
cup.
• Prepare controls as per supplier information.

4
The recommended control requirement for the ARCHITECT LH assay is EXPECTED VALUES
that a single sample of all control levels be tested once every 24 hours The suggested normal range for the ARCHITECT LH assay represents
each day of use. If the quality control procedures in your laboratory require the LH values obtained from 199 normal males, 124 postmenopausal
more frequent use of controls to verify test results, follow your laboratory- females (not on hormone replacement therapy - HRT), and 64 normally
specific procedures or your federal, state and/or local accrediting agency menstruating females. For this study, the follicular phase was defined as
requirements or regulations. the period of time from 10 to 4 days prior to the mid-cycle peak. The luteal
Commercial controls should be used according to the guidelines and phase was defined as the period of time from 4 to 10 days following the
recommendations of the control manufacturer. In addition, each laboratory mid-cycle peak. Cycle days were synchronized to the mid-cycle peak, the
should establish its own concentration ranges for new control lots at each day on which the LH concentration was most elevated. The results are
control level employed. These ranges should be established according to presented in the following table.
your laboratory quality control policy and/or any local, state, and/or federal
LH Values (mIU/mL)
regulations or accreditation requirements. Concentration ranges provided
in the control package insert should be used only for guidance. Median/ Central 95% of Data
For any control material in use, the laboratory should ensure that the n Mean* Lower Limit Upper Limit
matrix of the control material is suitable for use in the assay per the assay Normal Males 199 2.96 0.57 12.07
package insert. Normally Menstruating
Refer to published guidelines for information or general control Females
recommendation, for example, Clinical Standards Institute (CLSI) Document Follicular Phase 303 3.98 1.80 11.78
C24-A325, Statistical Quality Control for Quantitative Measurement Mid-Cycle Peak 64 26.00* 7.59 89.08
Procedures: Principles and Definitions; Approved Guideline - Third Edition or
other published guidelines for general quality control recommendations. Luteal Phase 294 2.79* 0.56 14.00
Postmenopausal
Verification of Assay Claims Females
For protocols to verify package insert claims, refer to the ARCHITECT Without HRT 124 25.73* 5.16 61.99
System Operations Manual, Appendix B. The ARCHITECT LH assay
belongs to method group 6. It is recommended that each laboratory establish its own reference range
that is appropriate for the laboratory’s patient population (i.e., a normal
RESULTS range that reflects the type of specimen and demographic variables such
The ARCHITECT LH assay uses a 4 Parameter Logistic Curve fit as age and sex, as applicable).
(4PLC, Y-weighted) data reduction method to generate a calibration
curve. SPECIFIC PERFORMANCE CHARACTERISTICS
The ARCHITECT i System calculates the Calibrator A through F mean Data in the section SPECIFIC PERFORMANCE CHARACTERISTICS were
chemiluminescent signal from two Calibrator A through F replicates, generated using the ARCHITECT i2000SR System.
generates a calibration curve and stores the result. Assay results obtained in individual laboratories may vary from data
The default result unit for the ARCHITECT LH assay is mIU/mL. An presented.
alternate result unit, IU/L, may be selected for reporting results by editing Precision
assay parameter “Result units” to IU/L. The conversion factor used by The ARCHITECT LH assay is designed to have an assay imprecision
the system is 1. of ≤ 7% total (within laboratory) CV for LH values ≤ 70 mIU/mL and
Flags ≤ 10% total CV for LH values > 70 mIU/mL. For values < 1mIU/mL down
Some results may contain information in the Flags field. For a description to 0.5 mIU/mL the assay is designed to have an assay imprecision of
of the flags that may appear in this field, refer to the ARCHITECT System ≤ 0.07 SD.
Operations Manual, Section 5. A study was performed based on guidance from the CLSI protocol
EP5-A229. Four serum based panels (panel member 1-4) and four
Measuring Interval (Reportable Range)
plasma based panels (panel member 5-8) were assayed using two lots
Measuring interval is defined as the range of values in mIU/mL which meets of reagents, on two instruments, in replicates of three at two separate
the limits of acceptable performance for both imprecision and bias for an times per day for 20 days. Data from this study are summarized in the
undiluted sample. For the verification studies described in this package insert, following table.**
the range was 0.09 mIU/mL (Limit of Quantitation - LoQ) to 250.00 mIU/mL.
When using the manual or automated dilution procedure, the assay can report Within
values up to 1000.00 mIU/mL. Mean Laboratory
Panel Reagent Instru- Conc. Within Run (Total)
LIMITATIONS OF THE PROCEDURE
Member Lot ment n (mIU/mL) SD %CV SD %CV
• If the LH results are inconsistent with clinical evidence, additional
testing is suggested to confirm the result. 1 1 120 3.52 0.099 2.8 0.101 2.9
• For diagnostic purposes, results should be used in conjuction with 1 2 120 3.79 0.122 3.2 0.130 3.4
1
other data; e.g. symptoms, results of other tests, clinical impressions, 2 1 120 3.39 0.068 2.0 0.087 2.6
etc. 2 2 120 3.40 0.124 3.6 0.131 3.9
• Specimens from patients who have received preparations of mouse 1 1 119 16.01 0.297 1.9 0.389 2.4
monoclonal antibodies for diagnosis or therapy may contain human
1 2 120 17.18 0.487 2.8 0.533 3.1
anti-mouse antibodies (HAMA).26,27 Specimens containing HAMA 2
may produce anomalous values when tested with assay kits (such 2 1 120 15.84 0.307 1.9 0.464 2.9
as ARCHITECT LH) that employ mouse monoclonal antibodies.26 2 2 120 15.56 0.454 2.9 0.502 3.2
Additional information may be required for diagnosis. 1 1 119 47.69 1.086 2.3 1.291 2.7
• Heterophilic antibodies in human serum can react with reagent 1 2 120 51.03 1.522 3.0 1.989 3.9
immunoglobulins, interfering with in vitro immunoassays.28 Patients 3
2 1 120 47.82 1.012 2.1 1.442 3.0
routinely exposed to animals or to animal serum products can be
2 2 120 46.55 1.200 2.6 1.633 3.5
prone to this interference and anomalous values may be observed.
Additional information may be required for diagnosis. 1 1 120 222.58 4.913 2.2 7.937 3.6
1 2 120 239.29 7.147 3.0 7.927 3.3
4
2 1 120 228.31 5.188 2.3 8.962 3.9
2 2 119 220.87 4.888 2.2 6.160 2.8

5
 Within Sensitivity
Laboratory Limit of Blank, Limit of Detection and Limit of Quantitation
Mean
Panel Reagent Instru- Conc. Within Run (Total) The ARCHITECT LH assay is designed to have a Limit of Quantitation
Member Lot ment n (mIU/mL) SD %CV SD %CV (LoQ) of ≤ 0.5 mIU/mL.
1 1 120 1.00 0.029 2.9 0.035 3.5 The Limit of Quantitation (LoQ) of the ARCHITECT LH assay was
determined based on guidance from CLSI protocol EP17-A31. The LoQ is
1 2 120 1.08 0.037 3.5 0.044 4.1
5 defined as the lowest amount of analyte in a sample that can be accurately
2 1 119 0.95 0.023 2.4 0.028 2.9 quantitated with a total allowable error of ≤ 22%. The study was performed
2 2 120 0.94 0.028 3.0 0.031 3.3 with 4 blank (zero-level) samples and 8 samples with LH concentrations
1 1 120 5.21 0.109 2.1 0.230 4.4 ranging from 0.05 to 0.11 mIU/mL. These samples were tested over a
1 2 119* 5.58 0.171 3.1 0.180 3.2 period of minimum 3 days using 2 reagent lots and 2 instruments. The
6 observed LoQ for the ARCHITECT LH assay was 0.09 mIU/mL.
2 1 120 5.01 0.121 2.4 0.149 3.0
The Limit of Blank (LoB) and Limit of Detection (LoD) of the ARCHITECT
2 2 120 5.00 0.134 2.7 0.187 3.7 LH assay were determined, using proportions of false positives (α) less
1 1 120 46.23 0.787 1.7 1.073 2.3 than 5% and false negatives (β) less than 5%. These determinations were
1 2 120 49.17 1.581 3.2 1.827 3.7 performed using 4 blank (240 replicates) and 8 low level LH samples
7 (478 replicates); LoB = 0.01 mIU/mL and LoD = 0.03 mIU/mL.
2 1 120 46.08 1.271 2.8 1.738 3.8
2 2 120 45.76 1.032 2.3 1.227 2.7 Specificity
1 1 120 93.33 2.949 3.2 8.152 8.7 The specificity of the ARCHITECT LH assay was determined by studying
1 2 120 96.54 3.524 3.6 5.342 5.5 potential cross-reacting hormones (FSH at 150 mIU/mL, TSH at
8 100 µIU/mL, and hCG at 200,000 mIU/mL).
2 1 120 93.21 2.942 3.2 8.316 8.9
A study was performed with the ARCHITECT LH assay and data are
2 2 120 91.25 2.295 2.5 4.871 5.3
summarized in the following table*. Aliquots of ARCHITECT LH Calibrator A,
* One aberrant result was identified for panel member 6 and the within containing essentially no LH (0 mIU/mL), as well as a pool of normal
run and total imprecision were calculated with this replicate excluded. male serum (≤ 10 mIU/mL) and spiked normal male serum samples
** Representative data; results in individual laboratories may vary from (50‑70 mIU/mL) were supplemented with potential cross-reactants at the
these data. concentrations listed and tested for LH.
Accuracy by Recovery Cross- LH Analyte Level % Cross-
The ARCHITECT LH assay is designed to have a mean recovery of 100% Reactant Concentration mIU/mL Reactivitya
± 8% when analyzing samples spiked with known concentrations of LH 169 mIU/mL 0 0.01
at each level tested across the range of 10 to 70 mIU/mL. A study was FSH 179 mIU/mL ≤ 10 0.00
performed where known concentrations of LH were added to 15 specimens
162 mIU/mL 50-70 0.15
with different endogenous LH levels. Human pituitary luteinizing hormone
(lyophilized, > 95% purity) diluted in normal human male serum was used 124 µIU/mL 0 0.00
to spike stock solutions. The concentration of LH was obtained using the TSH 126 µIU/mL ≤ 10 0.01
ARCHITECT LH assay and the resulting percent recovery was calculated. 137 µIU/mL 50-70 -0.69
Data from this study are summarized in the following table.* 209,770 mIU/mL 0 0.01
Endogenous Value hCG 218,532 mIU/mL ≤ 10 0.01
Level LH Added Obtained 206,844 mIU/mL 50-70 0.01
Specimen (mIU/mL) (mIU/mL) (mIU/mL) % Recoverya * Representative data; results in individual laboratories may vary from
1 1.99 9.93 12.67 107.5 these data.
2 2.04 11.91 15.15 110.1 mean LH test concentration
3 3.95 9.86 13.28 94.6 a % Cross-Reactivity = – mean LH reference concentration x 100
4 5.21 11.77 15.64 88.6 concentration of cross-reactant
5 8.12 4.86 12.76 95.4
6 8.34 4.85 13.08 97.8 Interference
7 10.28 19.85 32.13 110.1 Potential interference in the ARCHITECT LH assay from hemoglobin,
8 11.76 24.78 38.40 107.5 bilirubin, triglycerides, and protein is designed to be within ± 8% in the
range of 10 to 70 mIU/mL.
9 12.02 54.50 65.64 98.4
Interference was demonstrated by a study based on guidance from the
10 19.37 39.43 58.45 99.1 CLSI protocol EP7-A234. Data from this study are summarized in the
11 20.14 44.32 62.44 95.5 following table*.
12 28.84 24.46 56.02 111.1
Potentially
13 24.06 34.35 58.41 100.0
Interfering % Change in Measured
14 31.67 8.90 39.37 86.5 Substance Concentration Concentration
15 43.37 19.32 65.83 116.2 10-20 mIU/mL 50-70 mIU/mL
Average Recovery: 101.2% Bilirubin ≥20 mg/dL 0 -1
* Representative data; results in individual laboratories may vary from Protein ≥12 g/dL -8 -8
these data. Triglycerides ≥3000 mg/dL 0 -2
a % Recovery = Value obtained - Endogenous level x 100 Hemoglobin ≥500 mg/dL 1 0
LH added * Representative data; results in individual laboratories may vary from
Linearity these data.
Based on guidance from CLSI protocol EP6-A30, a study was performed
to establish the linear range of the ARCHITECT LH assay. The assay
demonstrated linearity within the range of LoQ to 250.00 mIU/mL with an
absolute deviation from linearity of ≤ 1 mIU/mL for samples within LoQ
and 10 mIU/mL, ≤ 11% for samples within 10 and 70 mIU/mL, and ≤ 15%
for samples above 70 mIU/mL.

6
For interference by rheumatoid factor (RF) and HAMA the ARCHITECT LH 9. Harris GW, Naftolin F. The Hypothalamus and Control of Ovulation.
assay is designed to have a recovery of 100 ± 8% when analyzing RF or Br Med Bull 1970; 26:3-9.
HAMA positive samples spiked with known amounts of LH across the range 10. Knobil E. The Neuroendocrine Control of the Menstrual Cycle. Recent
of 10 to 70 mIU/mL. Results are summarized in the following table*. Prog Horm Res 1980; 36:53-88.
Potentially 11. Ross GT. Disorders of the Ovary and Female Reproductive Tract.In:
Interfering Wilson JD and Foster DW, editors. Williams Textbook of Endocrinology.
Substance Mean % Recovery Philadelphia: Saunders 1985; 206-58.
12. Vande Wiele RL, Bogumil J, Dyrenfurth I, et al. Mechanisms
10-20 mIU/mL 50-70 mIU/mL Overall
Regulating the Menstrual Cycle in Women. Recent Prog Horm Res
HAMA 101 97 99 1970; 26:63‑103.
RF 97 90 94 13. Bonnar J. Gynaecology and Obstetrics; The Hypothalamus and
* Representative data; results in individual laboratories may vary from Reproductive Function. In: Scott RB and Walker RM, editors. The
these data. Medical Annual. Bristol (England): J Wright & Sons 1973; 251-8.
14. Griffin JE, Wilson JD. Disorders of the Testes and Male Reproductive
Method Comparison Tract. In: Wilson JD and Foster DW, editors. Williams Textbook of
Correlation Endocrinology. Philadelphia: Saunders 1985; 259-311.
The ARCHITECT LH (2P40) assay is designed to have a slope of 0.9 to 1.15 15. Beastall GH, et al. Assays for Follicle Stimulating Hormone and
and a correlation coefficient of ≥ 0.95 for samples across the range of Luteinizing Hormone: Guidelines for the Provision of a Clinical
0 to 250 mIU/mL when compared to the ARCHITECT LH (6C25) assay. Biochemistry Service. Ann Clin Biochem 1987; 24:246-62.
A study was performed with the ARCHITECT LH assay based on guidance 16. Judd HL. Hormonal Dynamics Associated with the Menopause. Clin
from the CLSI protocol EP9-A2-IR32, where 107 unique specimens were Obstet Gynecol 1976; 19:775-88.
tested in replicates of two on both the investigational and comparator
17. Kletzky OA, Davajan V. Differential Diagnosis of Secondary
assays. Regression analysis was performed on the mean of the two
Amenorrhea. In: Mishell DR Jr, Brenner PF, editors. Management of
replicates using the Passing-Bablok33 and least squares methods. Data
Common Problems in Obstetrics and Gynecology. Oradell: Medical
from this study are summarized in the following table*.
Economics Books 1983; 352-6.
Regression Correlation 18. Lachelin G. The Polycystic Ovary Syndrome. In: Studd J, editor. Prog
Method n Slope Intercept Coefficient Obstet Gynecol. Edinburgh: Churchill Livingstone 1984; 290-301.
Least Squares 107 0.98 1.56 0.99 19. Franchimont P. Human Gonadotropin Secretion in Male Subjects. In:
Passing-Babloka 107 1.04 -0.27 0.99 James VHT, Serio M and Martini L editors. The Endocrine Function of
a A linear regression method with no special assumptions regarding the the Human Testis. New York: Academic Press 1973; 439-58.
distribution of the samples and measurement errors. 20. Marshall JC. Investigative Procedures. Pituitary-Gonadal Relations in
Infancy. J Clin Endocrinol Metab 1975; 4:545-51.
* Representative data; variables such as differences in sampling size and
sample population may impact the correlation of the assay, therefore, 21. US Department of Labor, Occupational Safety and Health
results in individual laboratories may vary from these data. Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
In this evaluation, specimen concentrations ranged from 1.00 mIU/mL 22. US Department of Health and Human Services. Biosafety in
to 207.80 mIU/mL with the ARCHITECT LH (2P40) assay and from Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
1.11 mIU/mL to 236.20 mIU/mL with the ARCHITECT LH (6C25) assay. The US Government Printing Office; December 2009.
specimens included in the study were sourced from external commercial 23. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
vendors and derived from different sample categories (normal males, Geneva: World Health Organization; 2004.
normally menstruating females, and postmenopausal females without 24. Clinical and Laboratory Standards Institute (CLSI). Protection
HRT). Since samples greater than 100 mIU/mL are rarely expected in of Laboratory Workers from Occupationally Acquired Infections:
normal populations, 7 normal male samples were spiked with LH containing Approved Guideline – Third Edition. CLSI Document M29-A3. Wayne,
material to cover the upper measuring range of the assay. PA: Clinical and Laboratory Standards Institute; 2005.
25. Clinical and Laboratory Standards Institute (CLSI). Statistical Quality
BIBLIOGRAPHY
Control for Quantitative Measurement Procedures: Principles and
1. Pierce JG, Parsons TF. Glycoprotein Hormones: Structure and
Definitions; Approved Guideline - Third Edition. CLSI Document
Function. Annu Rev Biochem 1981; 50:465-95.
C24-A3. Wayne, PA: Clinical and Laboratory Standards Institute
2. Shome B, Parlow AF. Human Follicle Stimulating Hormone (hFSH): 2006.
First Proposal for the Amino Acid Sequence of the α-subunit and
26. Primus FJ, Kelley EA, Hansen HJ, Goldbery DM. “Sandwich”-Type
First Demonstration of its α-subunit identity with an α-subunit of
Immunoassay of Carcinoembryonic Antigen in Patients Receiving
human Luteinizing Hormone (hLHα) J Clin Endocrinol Metab 1974;
Murine Monoclonal Antibodies for Diagnosis and Therapy. Clin Chem
39:199‑202.
1988; 34:261-4.
3. Sairam MR, Li CH. Human Pituitary Thyrotropin. Isolation and Chemical
27. Schroff RW, Foon KA, Beatty SM, Oldham RK, Morgan AC Jr.
Characterization of its Subunits. Biochem Biophys Res Commun 1973;
Human Anti-Murine Immunoglobulin Responses in Patients Receiving
51:336-42.
Monoclonal Antibody Therapy. Cancer Res 1985; 45:879-85.
4. Vaitukaitis JL, Ross GT, Braunstein GD, et al. Gonadotropins And Their
28. Boscato LM, Stuart MC. Heterophilic Antibodies: A Problem for All
Subunits: Basic and Clinical Studies. Recent Prog Horm Res 1976;
Immunoassays. Clin Chem 1988; 34:27.
32:289-331.
29. Clinical and Laboratory Standards Institute. Evaluation of Precision
5. Bishop WH, Nureddin A, Ryan RJ. Pituitary Luteinizing and Follicle
Performance of Quantitative Measurement Methods: Approved
Stimulating Hormones. In: Parons JA, editor. Peptide Hormones.
Guideline - Second Edition. CLSI Document EP5-A2. Wayne, PA:
Baltimore: University Park Press, 1976; 273-98.
Clinical and Laboratory Standards Institute, 2004.
6. Keutmann HT, Williams RM, Ryan RJ. Structure of Human Luteinizing
30. Clinical and Laboratory Standards Institute. Evaluation of the Linearity
Hormone Beta Subunit: Evidence for a Related Carboxyl-Terminal
of Quantitative Measurement Procedures: A Statistical Approach;
Sequence Among Certain Peptide Hormones. Biochem Biophys Res
Approved Guideline. CLSI Document EP6-A. Wayne, PA: Clinical and
Commun 1979; 90:842-8.
Laboratory Standards Institute, 2003.
7. Daughaday WH. The Adenohypophysis. In: Wilson JD and Foster DW,
31. Clinical and Laboratory Standards Institute. Protocols for Determination
editors. Williams Textbook of Endorcrinology. Philadelphia: Saunders,
of Limits of Detection and Limits of Quantitation: Approved Guideline.
1985; 80-3.
CLSI Document EP17-A. Wayne, PA: Clinical and Laboratory Standards
8. Schally AV, Arimura A, Kastin AJ, et al. Gonadotropin Releasing Institute, 2004.
Hormone: One Polypeptide Regulates Secretion of Luteinizing and
Follicle Stimulating Hormones. Science 1971; 173:1036-8.

7
32. Clinical and Laboratory Standards Institute. Method Comparison and
Bias Estimation Using Patient Samples; Approved Guideline - Second
Edition (Interim Revision). CLSI Document EP9-A2-IR. Wayne, PA:
Clinical and Laboratory Standards Institute, 2010.
33. Passing H, Bablok W. New biometrical procedure for testing the
equality of measurements from two different analytical methods.
J Clin Chem Clin Biochem 1983; 21:709-20.
34. Clinical and Laboratory Standards Institute. Interference Testing
in Clinical Chemistry; Approved Guideline - Second Edition. CLSI
Document EP7-A2. Wayne, PA: Clinical and Laboratory Standards
Institute, 2005.

The following US Patents are relevant to the ARCHITECT i System or its

components. There are other such patents and patent applications in the
United States and worldwide.

5,468,646 5,543,524 5,545,739

5,565,570 5,669,819 5,783,699

ARCHITECT and Chemiflex are trademarks of Abbott Laboratories in

various jurisdictions.
ProClin is property of its respective owner.

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

Distributed by Abbott Laboratories

Abbott Park, IL 60064 USA
and
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October 2012
© 2010, 2012 Abbott Laboratories