en

Intact PTH
system
8K25
84-6434/R5

Read Highlighted Changes

Intact PTH
Customer Service
United States: 1-877-4ABBOTT
International: Call your Abbott Representative

This package insert must be read carefully before product use. 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

Expiration Date Septum

Store at 2-8°C Replacement Caps

Consult instructions for use Reagent Lot

Serial Number Assay CD-ROM

Manufacturer Control Number

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

1
NAME WARNINGS AND PRECAUTIONS
ARCHITECT Intact PTH • For In Vitro Diagnostic Use.
INTENDED USE Safety Precautions
The ARCHITECT Intact PTH assay is an in vitro chemiluminescent • CAUTION: This product requires the handling of human specimens.
microparticle immunoassay (CMIA) for the quantitative determination of It is recommended that all human sourced materials be considered
intact parathyroid hormone (PTH) in human serum and plasma on the potentially infectious and handled in accordance with the OSHA
ARCHITECT i System. Standard on Bloodborne Pathogens.2 Biosafety Level 23 or other
appropriate biosafety practices4,5 should be used for materials that
SUMMARY AND EXPLANATION OF TEST contain or are suspected of containing infectious agents.
PTH is a single chain polypeptide of 84 amino acids produced by the
• This product contains sodium azide. For a specific listing, refer to
parathyroid gland. Intact PTH1-84 is secreted into the blood stream
the REAGENTS section of this package insert. Contact with acids
and undergoes extensive proteolytic modifications. In contrast to its
liberates very toxic gas. This material and its container must be
degradation products, the concentration of intact PTH is relatively
disposed of in a safe way.
independent of glomerular filtration rate and reflects the biologically
active portion of the hormone.1 • For product not classified as dangerous per European Directive
1999/45/EC as amended - Safety data sheet available for
The primary role of PTH is to regulate the blood calcium level. PTH
professional user on request.
synthesis and secretion are stimulated within a few minutes by low
concentrations of ionized calcium (Cai). The biological activity of PTH • For a detailed discussion of safety precautions during system
is to increase absorption of dietary calcium, decrease renal clearance operation, refer to the ARCHITECT System Operations Manual,
and mobilize skeletal calcium stores. Abnormally high Cai concentrations Section 8.
suppress secretion of PTH.1 Handling Precautions
In conjunction with serum calcium levels, the PTH assay may be used • Do not use reagent kits beyond the expiration date.
as an aid in the differential diagnosis of hypercalcemia, hypocalcemia • Do not pool reagents within a reagent kit or between reagent
and parathyroid disorders. PTH determination is important in monitoring kits.
dialysis patients to manage renal osteodystrophy. • Before loading the ARCHITECT Intact PTH Reagent Kit on the
BIOLOGICAL PRINCIPLES OF THE PROCEDURE system for the first time, the microparticle bottle requires mixing to
The ARCHITECT Intact PTH assay is a two-step sandwich immunoassay resuspend the microparticles that have settled during shipment. For
for the quantitative determination of intact PTH in human serum and microparticle mixing instructions, refer to the PROCEDURE, Assay
plasma using CMIA technology with flexible assay protocols, referred to Procedure section of this package insert.
as Chemiflex. • Septums MUST be used to prevent reagent evaporation and
In the first step, sample, assay diluent, and anti-PTH coated paramagnetic contamination, and to ensure reagent integrity. Reliability of assay
microparticles are combined. Intact PTH present in the sample binds to results cannot be guaranteed if septums are not used according
the anti-PTH coated microparticles. After washing, anti-PTH acridinium- to the instructions in this package insert.
labeled conjugate is added to create a reaction mixture in the second • To avoid contamination, wear clean gloves when placing a
step. Following another wash cycle, pre-trigger and trigger solutions are septum on an uncapped reagent bottle.
added to the reaction mixture. The resulting chemiluminescent reaction • Once a septum has been placed on an open reagent bottle, do
is measured as relative light units (RLUs). not invert the bottle as this will result in reagent leakage and
A direct relationship exists between the amount of intact PTH in the may compromise assay results.
sample and the RLUs detected by the ARCHITECT i System optics. • Over time, residual liquids may dry on the septum surface.
For additional information on system and assay technology, refer to the These are typically dried salts, which have no effect on assay
ARCHITECT System Operations Manual, Section 3. efficacy.
REAGENTS • For a detailed discussion of handling precautions during system
operation, refer to the ARCHITECT System Operations Manual,
Reagent Kit
Section 7.
NOTE: Some kit sizes are not available in all countries. Please contact
your local distributor. Storage Instructions
ARCHITECT Intact PTH Reagent Kit (8K25)
• 1 or 4 Bottle(s) (6.6 mL each) Anti-PTH (goat,
• The ARCHITECT Intact PTH Reagent Kit must be stored
polyclonal) coated microparticles in TRIS buffer. Preservative:
at 2-8°C in an upright position and may be used immediately after
sodium azide.
removal from 2-8°C storage.
• 1 or 4 Bottle(s) (5.9 mL each) Anti-PTH (goat,
polyclonal) acridinium-labeled conjugate in MES buffer with protein • When stored and handled as directed, reagents are stable until the
(bovine, goat) stabilizer. Preservative: sodium azide. expiration date.
• 1 or 4 Bottle(s) (10.0 mL each) Intact PTH Assay • The ARCHITECT Intact PTH Reagent Kit may be stored on board
Diluent containing phosphate buffer with protein (bovine, goat) the ARCHITECT i System for a maximum of 30 days. After 30 days,
stabilizer. Preservative: sodium azide. the reagent kit must be discarded. For information on tracking
onboard time, refer to the ARCHITECT System Operations Manual,
Assay Diluent Section 5.
ARCHITECT i Multi-Assay Manual Diluent (7D82-50) • Reagents may be stored on or off the ARCHITECT i System. If
• 1 Bottle (100 mL) ARCHITECT reagents are removed from the system, store them at 2-8°C (with
i Multi-Assay Manual Diluent containing phosphate buffered saline septums and replacement caps) in an upright position. For reagents
solution. Preservative: antimicrobial agent. stored off the system, it is recommended that they be stored in
Other Reagents their original trays and boxes to ensure they remain upright. If any
ARCHITECT i Pre-Trigger Solution bottle does not remain upright (with a septum installed) while
in refrigerated storage off the system, the reagent kit must be
• Pre-Trigger Solution containing 1.32%
discarded. After reagents are removed from the system, initiate a
(w/v) hydrogen peroxide.
reagent scan to update the onboard stability timer.
ARCHITECT i Trigger Solution
• Trigger Solution containing 0.35 N sodium Indications of Reagent Deterioration
hydroxide. When a control value is out of the specified range, it may indicate
deterioration of the reagents or errors in technique. Associated test
ARCHITECT i Wash Buffer
results are invalid and samples must be retested. Assay recalibration may
• Wash Buffer containing phosphate buffered saline be necessary. For troubleshooting information, refer to the ARCHITECT
solution. Preservative: antimicrobial agent. System Operations Manual, Section 10.

2
INSTRUMENT PROCEDURE • To ensure consistency in results, specimens must be transferred
• The ARCHITECT Intact PTH assay file (assay number 581) must be to a centrifuge tube and centrifuged at ≥ 10,000 RCF (Relative
installed on the ARCHITECT i System from the ARCHITECT i Assay Centrifugal Force) for 10 minutes before testing if
CD-ROM Addition E before performing the assay. • they contain fibrin, red blood cells, or other particulate matter,
• The ARCHITECT Intact PTH STAT assay file (assay number 585) or
must be installed on the ARCHITECT i System with STAT protocol • they require repeat testing.
capability from the ARCHITECT i Assay CD-ROM Addition E before Transfer clarified specimens to a sample cup or secondary tube
performing the assay. for testing.
• The Routine assay may not be available on all ARCHITECT i Systems. • Centrifuged specimens with a lipid layer on the top must be
• For detailed instructions on the assay file installation and on viewing transferred to a sample cup or secondary tube. Care must be taken
and editing assay parameters, refer to the ARCHITECT System to transfer only the clarified specimens without the lipemic material.
Operations Manual, Section 2.
Storage
• For information on printing assay parameters, refer to the ARCHITECT • Specimens may be stored on or off the clot, or red blood cells for up
System Operations Manual, Section 5. to 2 days refrigerated at 2-8°C.
• For a detailed description of system procedures, refer to the • If testing will be delayed more than 2 days, remove serum or plasma
ARCHITECT System Operations Manual. from the clot, or red blood cells and store frozen.
• The default result unit for the ARCHITECT Intact PTH assay is pg/mL. • Specimens stored frozen for 6 months showed no performance
An alternate result unit, pmol/L, may be selected for reporting results difference. Avoid more than 5 freeze/thaw cycles.
by editing assay parameter “Result concentration units” to pmol/L.
The conversion factor used by the system is 0.106. Shipping
• Conversion formula: (Concentration in pg/mL) x (0.106) = pmol/L. • Before shipping specimens, it is recommended that specimens be
removed from the clot or red blood cells.
SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS • When shipping specimens, package and label specimens in
Specimen Types compliance with applicable state, federal, and international
The specimen collection tubes listed below were verified to be used with regulations covering the transport of clinical specimens and
the ARCHITECT Intact PTH assay. infectious substances.
• Human serum (use of serum separator tubes may result in a • Specimens may be shipped on wet ice or on dry ice. Do not exceed
decrease in concentration). the storage time limitations listed above.
• Human plasma collected in:
PROCEDURE
• Lithium Heparin
Materials Provided
• Sodium Heparin • 8K25 ARCHITECT Intact PTH Reagent Kit
• Potassium EDTA
• Liquid anticoagulants may have a dilution effect resulting in lower Materials Required but not Provided
concentrations for individual patient specimens. • ARCHITECT i System
• The ARCHITECT i System does not provide the capability to verify • 1L66 ARCHITECT i - WW (excluding US) - Addition E
specimen type. It is the responsibility of the operator to verify that • 8K25-01 ARCHITECT Intact PTH Calibrators
the correct specimen types are used in the ARCHITECT Intact PTH • 8K25-10 ARCHITECT Intact PTH Controls
assay. • 7D82-50 ARCHITECT i
• Sodium Citrate, Sodium Fluoride/Potassium Oxalate, and Ammonium • ARCHITECT i
Heparin tubes cannot be used with the ARCHITECT Intact PTH • ARCHITECT i
assay.
• ARCHITECT i
Specimen Conditions • ARCHITECT i
• Do not use specimens with the following conditions: • ARCHITECT i
• heat-inactivated • ARCHITECT i
• pooled • ARCHITECT i
• grossly hemolyzed (> 500 mg/dL) • Pipettes or pipette tips (optional)
• obvious microbial contamination For information on materials required for maintenance procedures, refer
• cadaver specimens or any other body fluids to the ARCHITECT System Operations Manual, Section 9.
• For accurate results, serum and plasma specimens should be free of Assay Procedure
fibrin, red blood cells or other particulate matter. Serum specimens
• Before loading the ARCHITECT Intact PTH Reagent Kit on the
from patients receiving anticoagulant or thrombolytic therapy may
system for the first time, the microparticle bottle requires mixing to
contain fibrin due to incomplete clot formation.
resuspend the microparticles that have settled during shipment. After
• Use caution when handling patient specimens to prevent cross the first time the microparticles have been loaded, no further mixing
contamination. Use of disposable pipettes or pipette tips is is required.
recommended.
• Invert the microparticle bottle 30 times.
• For optimal results, inspect all specimens for bubbles. Remove
• Visually inspect the bottle to ensure microparticles are
bubbles with an applicator stick before analysis. Use a new applicator
resuspended. If microparticles remain adhered to the bottle,
stick for each specimen to prevent cross contamination.
continue inverting the bottle until the microparticles have been
Preparation for Analysis completely resuspended.
• Follow the tube manufacturer’s processing instructions for serum • If the microparticles do not resuspend, DO NOT USE. Contact
and plasma collection tubes. Gravity separation is not sufficient for your local Abbott representative.
specimen preparation. • Once the microparticles have been resuspended, place a
• Mix thawed specimens thoroughly by low speed vortexing or by septum on the bottle. For instructions on placing septums
inverting 10 times. Visually inspect the specimens. If layering or on bottles, refer to the Handling Precautions section of this
stratification is observed, continue mixing until specimens are visibly package insert.
homogeneous.

3
• Load the ARCHITECT Intact PTH Reagent Kit on the ARCHITECT Calibration
i System or the ARCHITECT i System with STAT protocol capability. • To perform an ARCHITECT Intact PTH calibration, test calibrators
• Verify that all necessary assay reagents are present. A, B, C, D, E, and F in replicates of two. A single sample of each Intact
• Ensure that septums are present on all reagent bottles. PTH control level must be tested to evaluate the assay calibration.
• Order calibration, if necessary. Ensure that assay control values are within the concentration ranges
specified in the control package insert. Calibrators should be priority
• For information on ordering calibrations, refer to the ARCHITECT loaded.
System Operations Manual, Section 6.
• Calibration Range:
• Order tests.
• Routine protocol: 0.0 – 3000.0 pg/mL
• For information on ordering patient specimens and controls
and for general operating procedures, refer to the ARCHITECT • STAT protocol: 0.0 – 2500.0 pg/mL
System Operations Manual, Section 5. • Once an ARCHITECT Intact PTH calibration is accepted and stored,
• The minimum sample cup volume is calculated by the system and all subsequent samples may be tested without further calibration
is printed on the Orderlist report. No more than 9 replicates may unless:
be sampled from the same sample cup. To minimize the effects of • A reagent kit with a new lot number is used.
evaporation, verify adequate sample cup volume is present before • Controls are out of range.
running the test. • For detailed information on how to perform an assay calibration,
• Priority: 200 μL for the first ARCHITECT Intact PTH test plus refer to the ARCHITECT System Operations Manual, Section 6.
150 μL for each additional ARCHITECT Intact PTH test from the QUALITY CONTROL PROCEDURES
same sample cup.
The recommended control requirement for the ARCHITECT Intact PTH
• ≤ 3 hours on board: 200 μL for the first ARCHITECT Intact PTH assay is that a single sample of each control be tested once every
test plus 150 μL for each additional ARCHITECT Intact PTH test 24 hours each day of use. If laboratory quality control procedures
from the same sample cup. require more frequent use of controls to verify test results, follow those
• > 3 hours on board: additional sample volume is required. For procedures.
information on sample evaporation and volumes, refer to the The ARCHITECT Intact PTH Control values must be within the acceptable
ARCHITECT System Operations Manual, Section 5. ranges specified in the control package insert. If a control is out of its
• If using primary or aliquot tubes, use the sample gauge to ensure specified range, the associated test results are invalid and samples must
sufficient patient specimen is present. be retested. Recalibration may be indicated.
• Prepare calibrators and controls.
Verification of Assay Claims
• Mix ARCHITECT Intact PTH Calibrators and Controls by gentle For protocols to verify package insert claims, refer to the ARCHITECT
inversion before use. System Operations Manual, Appendix B. The ARCHITECT Intact PTH
• To obtain the recommended volume requirements for the assay belongs to method group 1. ARCHITECT Intact PTH Calibrators
ARCHITECT Intact PTH Calibrators and Controls, hold the bottles may be used when MasterCheck is not available. Refer to the ARCHITECT
vertically and dispense 15 drops of each calibrator or 10 drops System Operations Manual, Appendix B.
of each control into each respective sample cup.
• Load samples. RESULTS
• For information on loading samples, refer to the ARCHITECT Calculation
System Operations Manual, Section 5. The ARCHITECT Intact PTH assay uses a point to point data reduction
method to generate a calibration curve.
• Press RUN.
• For additional information on principles of operation, refer to the Flags
ARCHITECT Operations Manual, Section 3. • Some results may contain information in the Flags field. For a
• For optimal performance, it is important to perform routine description of the flags that may appear in this field, refer to the
maintenance as described in the ARCHITECT System Operations ARCHITECT System Operations Manual, Section 5.
Manual, Section 9. When a laboratory requires more frequent Measurement Range (Reportable Range)
maintenance, follow those procedures. The measurement range for the ARCHITECT Intact PTH assay is
Specimen Dilution Procedures - STAT protocol: 4.0 pg/mL to 2500.0 pg/mL
Specimens with an intact PTH concentration of > 3000.0 pg/mL - Routine protocol: 3.0 pg/mL to 3000.0 pg/mL
(Routine protocol) or > 2500.0 pg/mL (STAT protocol) will be flagged as Results below the range of measurement should be reported as
“> 3000.0 pg/mL” or “> 2500.0 pg/mL” and may be diluted with the < 4.0 pg/mL or < 3.0 pg/mL, respectively.
Manual Dilution Procedure.
• Manual dilutions should be performed as follows:
LIMITATIONS OF THE PROCEDURE
• If the Intact PTH results are inconsistent with clinical evidence,
• The suggested dilution for the ARCHITECT Intact PTH assay
additional testing is suggested to confirm the result.
is 1:2.
• For diagnostic purposes, the results should be used in conjunction
• Add 150 μL of the patient specimen to 150 μL of ARCHITECT
with other data; e.g., symptoms, results of other tests, clinical
i Multi-Assay Manual Diluent.
impressions, etc.
• The operator must enter the dilution factor in the Patient or
• Heterophilic antibodies in human serum can react with reagent
Control order screen. The system will use this dilution factor to
immunoglobulins, interfering with in vitro immunoassays.6 Patients
automatically calculate the concentration of the sample before
routinely exposed to animals or to animal serum products can be
dilution and report the result. The result (before dilution factor is
prone to this interference and anomalous values may be observed.
applied) should be greater than 1.0 pg/mL.
Additional information may be required for diagnosis.
• For detailed information on ordering dilutions, refer to the ARCHITECT
System Operations Manual, Section 5.

4
EXPECTED VALUES Dilution Observed Values % Mean
It is recommended that each laboratory establish its own reference Sample Factor (pg/mL) Recoverya
range, which may be unique to the population it serves depending on the 1 undiluted 65.6 –
geographical, dietary, or environmental factors.
0.2 to 0.8 53.8 to 12.4 97
A study was performed for the ARCHITECT Intact PTH assay to establish
the reference range using plasma specimens from apparently healthy 2 undiluted 779.9 –
adults. Data from this study are summarized in the following table.* 0.2 to 0.8 644.7 to 163.2 103
3 undiluted 2257.0 –
Intact PTH (pg/mL)
0.2 to 0.8 1860.5 to 435.2 98
2.5th 97.5th
n Median percentile percentile In addition, a dilution study was performed using specimens with different
high and low intact PTH concentration values ranging between 19.1 pg/mL
Healthy Adults 143 35.6 15.0 68.3
and 2038.8 pg/mL. The low level sample was used to dilute the high level
* Representative performance data are shown. Results obtained at sample to different concentrations (dilution factors of 0.25, 0.50 and 0.75).
individual laboratories may vary. Data from this study are summarized in the following table.*
SPECIFIC PERFORMANCE CHARACTERISTICS Undiluted Diluted
Precision Concentration Concentration % Mean
The ARCHITECT Intact PTH assay is designed to have precision of ≤ 9% Sample Level (pg/mL) Range (pg/mL) Recoverya
total CV for the Low Control and of ≤ 7% total CV for the Medium and 1 Low 19.1 168.3 to 101
High Control. A study was performed for the ARCHITECT Intact PTH High 615.0 477.1
assay, based on guidance from the National Committee for Clinical 2 Low 21.5 339.5 to 104
Laboratory Standards Institute (NCCLS) Protocol EP5-A.7 Multiple High 1271.9 989.4
ARCHITECT Intact PTH control lots were assayed using two lots of
reagents in replicates of two at two separate times per day for 20 days 3 Low 22.8 522.6 to 102
at one site on two instruments using the STAT protocol and at a second High 2038.8 1580.8
site on two instruments using the Routine protocol.
In addition, a second precision study was performed, where two lots a % Recovery = Observed Value (pg/mL) x 100
of reagents were assayed in four replicates per run at two separate Expected Value (pg/mL)
times per day over 10 days on one instrument at a third site using the
% Mean Recovery = Mean of % Recovery of all dilutions of a sample
STAT protocol and on one instrument at a fourth site using the Routine
protocol. Each reagent lot used a single calibration curve throughout the * Representative performance data are shown. Results obtained at
study. Data from both studies are summarized in the following tables.* individual laboratories may vary.
ARCHITECT Intact PTH Precision Using STAT Protocol Functional Sensitivity
Mean Conc. Within Run Totala The ARCHITECT Intact PTH assay is designed to have a functional
Sample n (pg/mL) SD %CV SD %CV sensitivity of ≤ 5 pg/mL at a total CV of 20%. A study was performed
using human samples with concentrations targeted at 3 pg/mL, 4 pg/mL
Low Control 878 8.5 0.74 8.7 0.74 8.7
and 5 pg/mL of intact PTH. Those samples were tested in replicates
Medium Control 880 56.5 2.34 4.1 2.35 4.2 of two over 10 days using two reagent lots on two instruments using
High Control 880 208.9 8.62 4.1 8.62 4.1 the STAT protocol and on one instrument using the Routine protocol.
Functional sensitivity was determined to be ≤ 4 pg/mL* for the STAT
ARCHITECT Intact PTH Precision Using Routine Protocol protocol and ≤ 3 pg/mL* for the Routine protocol.
Mean Conc. Within Run Totala * Representative performance data are shown. Results obtained at
Sample n (pg/mL) SD %CV SD %CV individual laboratories may vary.
Low Control 880 10.7 0.65 6.1 0.69 6.4 Analytical Sensitivity
Medium Control 880 69.6 2.28 3.3 2.31 3.3 The ARCHITECT Intact PTH assay is designed to have an analytical
High Control 880 255.8 7.40 2.9 7.56 3.0 sensitivity of ≤ 1 pg/mL. Analytical sensitivity is defined as the concentration
a Total assay variability contains within run, run to run and day to day at two standard deviations above the calibrator A (0.0 pg/mL). In a study
(n = 12 runs, 20 replicates of calibrator A and 10 replicates of calibrator B,
variability.
using three instruments and two reagent lots), the analytical sensitivity
* Representative performance data are shown. Results obtained at was calculated to be 0.23 pg/mL* using the Routine protocol and
individual laboratories may vary. 0.31 pg/mL* using the STAT protocol at a 95% level of confidence.
Recovery * Representative performance data are shown. Results obtained at
The ARCHITECT Intact PTH assay is designed to have a mean recovery individual laboratories may vary.
of 100 ± 10%. A study was performed where known concentrations Specificity
(0, 4.8, 24, 120, 600 pg/mL) of intact PTH were added to 10 aliquots
The specificity of the ARCHITECT Intact PTH assay is designed to
of human plasma with endogenous levels ranging from 22.9 pg/mL to
have a cross-reactivity of ≤ 0.01% when tested with structurally similar
162.8 pg/mL of intact PTH. The concentration of intact PTH and the
compounds listed in the table below. A study was performed with
percent recovery were calculated for each sample. The percent recovery
the ARCHITECT Intact PTH assay based on guidance from NCCLS
of the ARCHITECT Intact PTH assay resulted in a mean of 101%. Data
Protocol EP7-A.8 Aliquots of ARCHITECT Intact PTH Calibrator A were
are representative performance data, but results obtained at individual
supplemented with potential cross-reactants at the concentrations listed
laboratories may vary.
and tested for intact PTH. Data from this study are summarized in the
Linearity following table.*
The ARCHITECT Intact PTH assay is designed to recover diluted specimens
within ± 10% of the expected result in the dilution range from 20% to 80%.
A dilution linearity study was performed using specimens with undiluted
intact PTH values that ranged between 65.6 pg/mL and 2257.0 pg/mL.
These specimens were diluted manually using ARCHITECT i Multi-Assay
Manual Diluent at various dilution factors (0.2 to 0.8) to result in 80%
to 20% of the endogenous intact PTH level. Data from this study are
summarized in the following tables.*

5
PTH fragment Concentrations % Cross-Reactivitya BIBLIOGRAPHY
1-34 100000 pg/mL 0.00 1. Goltzman D, Hendy GN. Parathyroid hormone. In: Becker KL, editor.
Principles and Practice of Endocrinology and Metabolism, 3rd edition.
39-68 100000 pg/mL 0.00 Philadelphia, PA: Lippincott Williams & Wilkins; 2001:497-512.
53-84 100000 pg/mL 0.00 2. US Department of Labor, Occupational Safety and Health
44-68 100000 pg/mL 0.00 Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
39-84 100000 pg/mL 0.00 3. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories. 5th. ed. Washington, DC:
Mean Value spiked - US Government Printing Office; January 2007.
a % Cross-Reactivity = Mean Value non spiked (pg/mL)
x 100 4. World Health Organization. Laboratory Biosafety Manual. Geneva:
Concentration of Cross-Reactant (pg/mL) World Health Organization; 2004.
* Representative performance data are shown. Results obtained at 5. Clinical and Laboratory Standards Institute. Protection of Laboratory
individual laboratories may vary. Workers from Occupationally Acquired Infections: Approved
Guideline—Third Edition. CLSI Document M29-A3. Wayne, PA:
Interference Clinical and Laboratory Standards Institute, 2005.
Potential interference in the ARCHITECT Intact PTH assay from 6. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all
hemoglobin, bilirubin, triglycerides, and protein at the levels indicated immunoassays. Clin Chem 1988;34(1):27-33.
below is designed to be ≤ 10%. Interference was demonstrated by a
study based on guidance from the NCCLS Protocol EP7-A.8 There was 7. National Committee for Clinical Laboratory Standards. Evaluation
no significant interference observed since the % mean recovery is within of Precision Performance of Clinical Chemistry Devices–Approved
± 10% of the expected value. Data from this study are summarized in the Guideline. NCCLS document EP5-A. Wayne, PA: NCCLS, 1999.
following table.* 8. National Committee for Clinical Laboratory Standards. Interference
Testing in Clinical Chemistry: Approved Guideline. NCCLS document
Potentially Interfering EP7-A. Wayne, PA: NCCLS, 2002.
Substance Concentration % Mean Recoverya 9. Passing H, Bablok W. A new biometrical procedure for testing the
Hemoglobin 500 mg/dL 102 equality of measurements from two different analytical methods.
Bilirubin 20 mg/dL 98 J Clin Chem Clin Biochem 1983;21:709-20.
Triglycerides 5000 mg/dL 105
Protein low 4 g/dL 106 ARCHITECT and Chemiflex are property of Abbott Laboratories in various
jurisdictions.
Protein high 9.5 g/dL 93
Protein high (Routine protocol) 10.5 g/dL 94**
ABBOTT
a % Recovery = Observed Value (pg/mL) x 100 Max-Planck-Ring 2
Expected Value (pg/mL) 65205 Wiesbaden
Germany
% Mean Recovery = Mean of % Recovery of all tested samples +49-6122-580
* Representative performance data are shown. Results obtained at
individual laboratories may vary. Produced by Biokit S.A., 08186 Barcelona, Spain
** For using the STAT protocol, interference with high levels of protein for Abbott Diagnostics Division
may be observed. Distributed by Abbott Laboratories
Method Comparison Abbott Park, IL 60064 USA
The ARCHITECT Intact PTH assay is designed to have a correlation and
coefficient of ≥ 0.95 when evaluated against a comparison assay. A ABBOTT,
study was performed with the ARCHITECT Intact PTH assay, where
65205 Wiesbaden, Germany
regression analysis was performed using the Passing-Bablok and Least
Squares regression methods. Data from this study are summarized in the ABBOTT
following table.* Diagnostics Division
ARCHITECT Intact PTH vs. Comparison Assay
November 2008
Regression Correlation © 2006, 2008 Abbott Laboratories
Method n Slope Intercept Coefficient
Passing-Babloka 199 1.02 0.61
0.99
Least Squares 199 0.98 9.00
a A linear regression method with no special assumptions regarding the
distribution of samples and measurement errors.9
In this evaluation, specimen concentrations ranged from 5.9 pg/mL to
1277.0 pg/mL with the ARCHITECT Intact PTH assay and from 7.5 pg/mL
to 1344.3 pg/mL with the comparison assay.
Another study was performed comparing the ARCHITECT Intact PTH
assay to a diagnostic assay commercially available. In the study
709 specimens were analyzed resulting in a correlation coefficient
of 0.99*. The specimen concentrations ranged from 1.5 to
2326.9 pg/mL with the ARCHITECT Intact PTH assay and from
1.2 to 1813.0 pg/mL with the commercially available diagnostic kit. The
specimen categories included in the study are as follows: normal adults
(285), series of intraoperative measurements of parathyroidectomy (32),
Hypoparathyroidism (20), Primary Hyperparathyroidism (39), Chronic
Renal Failures (93), Hypercalcemia of malignancies (40), randomized
PTH levels (200).
* Representative performance data are shown. Variables such as
differences in sampling size and sample population may impact the
correlation of the assay, therefore, results obtained at individual
laboratories may vary from these data.