6K89-30

AMMONIA ULTRA
NOTE: This package insert must be read carefully prior to product use. WARNINGS AND PRECAUTIONS
Package insert instructions must be followed accordingly. Reliability of
assay results cannot be guaranteed if there are any deviations from the Precautions for Users
instructions in this package insert. • For in vitro diagnostic use.
NOTE: Changes Highlighted • Do not use components beyond the expiration date.
• Do not mix materials from different kit lot numbers.
INTENDED USE • CAUTION: This product requires the handling of human specimens.
The MULTIGENT Ammonia Ultra assay is intended for the quantitative It is recommended that all human-sourced materials be considered
enzymatic determination of ammonia in human plasma on the potentially infectious and be handled in accordance with the OSHA
ARCHITECT c Systems. Standard on Bloodborne Pathogens.3 Biosafety Level 24 or other
appropriate biosafety practices5,6 should be used for materials that
SUMMARY AND EXPLANATION OF TEST contain or are suspected of containing infectious agents.
Ammonia, derived from the catabolism of amino acids and from the • This product contains sodium azide; for a specific listing, refer to
action of intestinal bacteria on dietary protein, is converted to urea the REAGENTS section of this package insert. Contact with acids
in the liver hepatocytes and so rendered non-toxic.1 Studies have liberates very toxic gas. This material and its container must be
shown that excess ammonia can have a toxic effect on the central disposed of in a safe way.
nervous system and clinical manifestations are typically neurological NOTE: Refer to Section 8 of the ARCHITECT System Operations
disturbances. Elevated ammonia may also be observed in severe liver Manual for proper handling and disposal of reagents containing
failure, as may occur in Reye’s Syndrome, viral hepatitis, or cirrhosis. sodium azide.
Hyperammonemia occurs with genetic defects of the urea cycle and • The following warnings and precautions apply to the :
some other hereditary disorders. Therefore, elevated plasma ammonia
may occur in the pediatric population. Elevated ammonia has also been WARNING: Contains methylisothiazolone.
reported due to administration of valproic acid.2 H317 May cause an allergic skin reaction.
Prevention
PRINCIPLES OF PROCEDURE P261 Avoid breathing mist/vapors/spray.
Ammonia, in the presence of glutamate dehydrogenase (GLDH), P280 Wear protective gloves/protective clothing/
combines with α-ketoglutarate and NADH to yield glutamate and NAD+. eye protection.
The decrease in absorbance (NADH to NAD+) at 340 nm is proportional P272 Contaminated work clothing should not be
to the ammonia concentration in the examined plasma. The reagent allowed out of the workplace.
contains lactate dehydrogenase (LDH) in excess, to rapidly reduce Response
endogenous pyruvate so that it does not interfere with the assay system. P302+P352 IF ON SKIN: Wash with plenty of soap and
Methodology: Glutamate Dehydrogenase water.
P333+P313 If skin irritation or rash occurs: Get
REAGENTS medical advice/attention.
P363 Wash contaminated clothing before reuse.
Reagent Kit
6K89-30 MULTIGENT Ammonia Ultra is supplied as a SPECIMEN COLLECTION AND HANDLING
two-component kit, which contains:
3 x 20 mL Suitable Specimens
1 x 10 mL Plasma
Estimated tests per kit: 243 • Use nonhemolyzed plasma collected by standard venipuncture
techniques. Hemolyzed samples should not be used as erythrocytes
Calculation is based on the minimum reagent fill volume per kit. contain ammonia levels approximately three times that of plasma.7
Reactive Ingredients Concentration • Acceptable anticoagulants are lithium heparin (with or without gel
barrier), sodium heparin, and EDTA. Do not use ammonium heparin.
Tris Buffer (pH 8.7) 100 mmol/L
AMMONIA ULTRA α-Ketoglutarate 7.5 mmol/L • The collection tube must be completely filled with blood and
NADH ≥ 0.2 mmol/L immediately placed on ice.
6K89-30 • Centrifuge the cold sample as quickly as possible and separate the
GLDH ≥ 4,000 U/L
LDH ≥ 30,000 U/L plasma from blood cells according to the specimen collection tube
Symbols in Product Labeling manufacturer’s instructions. Ensure centrifugation is adequate to
Ammonium Sulfate 500 μg/dL (293.50 μmol/L)
Calibrator remove platelets.
Nonreactive Ingredients: contains sodium azide (< 0.1%). NOTE: Rapid separation of plasma from blood cells is critical for
Concentration contains preservative. obtaining reliable results. The standard recommendation is no more
than 15 minutes from sample collection to the start of centrifugation.
Contents of kit For product questions contact Abbott Laboratories Customer Support. REAGENT HANDLING AND STORAGE Timing is especially critical for patients with liver disease.8 Delays
United States: 1-877-4ABBOTT exceeding 15 minutes have been shown to increase ammonia
Contains sodium azide. Contact with acids Reagent Handling
liberates very toxic gas. Canada: 1-800-387-8378 (English speaking customers) concentration even at 0°C.1 Follow the plasma ammonia protocol
1-800-465-2675 (French speaking customers) • Ready for use. established for your laboratory.
Identifies products to be used together International: Call your local Abbott representative • Ready for use. Sources of contamination include (but are not restricted to) cigarette
• Remove air bubbles, if present in the reagent cartridge, with a new smoking (patient and phlebotomy staff), air in the laboratory, and
Ingredients applicator stick. Alternatively, allow the reagent to sit at the laboratory glassware.
appropriate storage temperature to allow the bubbles to dissipate.
In vitro diagnostic medical device For total sample volume requirements, refer to the ASSAY PARAMETERS
To minimize volume depletion, do not use a transfer pipette to remove
section of this package insert and Section 5 of the ARCHITECT System
Batch code/Lot number the bubbles.
Operations Manual.
CAUTION: Reagent bubbles may interfere with proper detection of
SENTINEL CH. SpA reagent level in the cartridge, causing insufficient reagent aspiration
Reagent 1
Via Robert Koch, 2
Specimen Storage
that could impact results. Plasma
Catalog number/List number Milan 20152 Italy
Serial number
Reagent Storage Temperature Maximum Storage Bibliographic
• Unopened and are stable until the expiration date when Reference
Warning: May cause an allergic reaction. stored at 2 to 8°C. 2 to 8°C 2 hours 9, 10
• Reagent stability is 15 days if the reagent is uncapped and onboard. -20°C 3 weeks 9
Consult instructions for use Guder et al.9 suggest storage of frozen specimens at -20°C for no longer
• Opened calibrator is stable for 120 days at 2 to 8°C if contamination
Distributed by is avoided and vials are recapped immediately after use. than the time interval cited above. However, limitations of laboratory
Use by/Expiration date
Abbott Laboratories Inc.
equipment make it necessary in practice for clinical laboratories to
Abbott Park, IL 60064 USA
Indications of Deterioration establish a range around -20°C for specimen storage. This temperature
Manufacturer and Reagents and calibrator must be clear. Instability or deterioration should range may be established from either the freezer manufacturer’s
ABBOTT be suspected if there are visible signs of leakage, turbidity, microbial specifications or your laboratory standard operating procedure(s) for
Temperature limitation 65205 Wiesbaden, Germany
growth, or if calibration does not meet the appropriate package insert specimen storage.
November 2010 and/or ARCHITECT System Operations Manual criteria. NOTE: Stored specimens must be inspected for particulates. If present,
6K8930_IFU_01 mix and centrifuge the specimen to remove particulates prior to testing.

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PROCEDURE LIMITATIONS OF THE PROCEDURE
The Ammonia Ultra assay 6K89-30 is validated for use only on the
Materials Provided ARCHITECT c Systems.
6K89-30 MULTIGENT Ammonia Ultra Kit
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC
Materials Required but not Provided PERFORMANCE CHARACTERISTICS sections of this package insert.
• 6K89-20 MULTIGENT Ammonia Controls
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution EXPECTED VALUES
Assay Procedure Reference Range
For a detailed description of how to run an assay on the ARCHITECT Range (μg/dL) Range (μmol/L)
c Systems, refer to Section 5 of the ARCHITECT System Operations Plasma7 31 to 123 18 to 72
Manual. It is recommended that each laboratory determine its own reference
Specimen Dilution Procedure range based upon its particular locale and population characteristics.
The ARCHITECT c Systems have an automatic dilution feature; refer to For diagnostic purposes, results obtained for ammonia should always be
Section 2 of the ARCHITECT System Operations Manual for additional evaluated taking into consideration the patient’s medical history and all
information. other clinical findings.
Plasma: Specimens with ammonia values exceeding 1,700 μg/dL
(997.90 μmol/L) are flagged and may be diluted using either SPECIFIC PERFORMANCE CHARACTERISTICS
the Automated Dilution Protocol or the Manual Dilution Procedure. Reportable Range
Automated Dilution Protocol The reportable range for MULTIGENT Ammonia Ultra is 8 to 1,700 μg/dL
If using an Automated Dilution Protocol, the system performs a 1:1.85 (4.70 to 997.90 μmol/L).
dilution of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor.
Limit of Detection (LOD)
The LOD for MULTIGENT Ammonia Ultra is 8 μg/dL (4.70 μmol/L).
Manual Dilution Procedure
LOD was calculated on 20 replicates of normal saline and reported as
• Use saline (0.85% to 0.90% NaCl) to dilute the sample. the “mean zero value + 3 SD”.
• The operator must enter the dilution factor in the patient or control
order screen. The system uses this dilution factor to automatically Interfering Substances
correct the concentration by multiplying the result by the entered Interference studies were conducted using an acceptance criteria of
factor. ±10% deviation from the target value. MULTIGENT Ammonia Ultra is
• If the operator does not enter the dilution factor, the result must be not affected by the presence of the following interferents up to the
multiplied by the appropriate dilution factor before reporting the result. concentrations indicated below.
NOTE: If a diluted sample result is flagged indicating it is less than the Interfering Substance Interferent Concentration
linear low limit, do not report the result. Rerun using an appropriate Ascorbic acid 40 mg/dL (2271 μmol/L)
dilution. Bilirubin 20 mg/dL (342 μmol/L)
For detailed information on ordering dilutions, refer to Section 5 of the Pyruvate 6.58 mg/dL (750 μmol/L)
ARCHITECT System Operations Manual. Human triglyceride 700 mg/dL (7.91 mmol/L)
Hemoglobin: hemolyzed samples should not be used as erythrocytes
CALIBRATION contain ammonia levels approximately 3 times that of plasma.7
The MULTIGENT Ammonia Ultra assay must be calibrated using the THIS PAGE INTENTIONALLY LEFT BLANK
calibrator included in the kit. Precision
Calibration is stable for approximately 24 hours and is required with The precision of the MULTIGENT Ammonia Ultra assay is
each change in reagent lot number. Verify calibration curve with at ≤10% Total CV. Precision was determined over 5 days with two runs
least two levels of controls according to the established quality control and four replicates of each control per day. Representative results are
requirements for your laboratory. If control results fall outside acceptable summarized below.
ranges, recalibration may be necessary. Control Level 1 Level 2 Level 3
For a detailed description of how to calibrate an assay, refer to Section 6 N 40 40 40
of the ARCHITECT System Operations Manual. Mean (μg/dL) 56.10 268.63 368.95
SD 1.15 2.06 1.99
Standardization Within Run %CV 2.05 0.77 0.54
The calibrator value is verified using an internal standard obtained from SD 2.53 2.88 1.43
ammonium sulfate puriss. (ultrapure). Between Run %CV 4.50 1.07 0.39
Total SD 2.67 3.40 2.36
QUALITY CONTROL %CV 4.76 1.27 0.64
As appropriate, refer to your laboratory standard operating procedure(s) Method Comparison
and/or quality assurance plan for additional quality control requirements
and potential corrective actions: Plasma results from the MULTIGENT Ammonia Ultra assay on
an ARCHITECT c System were compared with the results from a
• Two levels of controls (normal and abnormal) are to be run every commercially available glutamate dehydrogenase (GLDH) methodology
24 hours.
and a commercially available micro-diffusion methodology.
• If more frequent control monitoring is required, follow the established
quality control procedures for your laboratory. ARCHITECT vs. ARCHITECT vs.
• If quality control results do not meet the acceptance criteria GLDH Assay Micro-diffusion Assay
defined by your laboratory, patient values may be suspect. Follow N 65 60
the established quality control procedures for your laboratory. Y - Intercept 2.5257 21.4942
Recalibration may be necessary. Correlation Coefficient 0.9986 0.9831
• Review quality control results and acceptance criteria following a Slope 0.9927 0.8956
change of reagent or calibrator lot. Range (μg/dL) 38 to 1655 19 to 680

RESULTS
Refer to Appendix C of the ARCHITECT System Operations Manual for
information on results calculations.
To convert results from μg/dL to μmol/L, multiply μg/dL by 0.587. 11
Representative performance data are given in the EXPECTED VALUES
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
package insert. Results obtained in individual laboratories may vary.

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 BIBLIOGRAPHY
1. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry,
3rd ed. Philadelphia, PA: WB Saunders; 1999:1146–7.
2. Wadzinski J, Franks R, Roane D, et al. Valproate-associated
hyperammonemic encephalopathy. J Am Board Fam Med 2007;
20(5):499–502.
3. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030. Bloodborne Pathogens.
4. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories, 5th ed. Washington,
DC: US Government Printing Office, January 2007.
5. World Health Organization. Laboratory Biosafety Manual, 3rd ed.
Geneva: World Health Organization, 2004.
6. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved
Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and Laboratory
Standards Institute, 2005.
7. Pesce AJ, Kaplan LA, editors. Methods in Clinical Chemistry. St
Louis, MO: CV Mosby; 1987:1088–92.
8. Huizenga JR, Tangerman A, Gips CH. Determination of ammonia in
biological fluids. Ann Clin Biochem 1994;31:529–43.
9. Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of
Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:16–7.
10. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
11. Tietz NW, editor. Clinical Guide to Laboratory Tests, 3rd ed.
Philadelphia, PA: WB Saunders; 1995:44–5.

TRADEMARKS
The ARCHITECT c System family of instruments consists of c 4000,
c 8000, and c16000 Systems.
ARCHITECT, c 4000, c 8000, c16000, c System, MULTIGENT, and
SmartWash are trademarks of Abbott Laboratories in various
jurisdictions.
All trademarks are property of their respective owners.

6K8930_IFU_01

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 c Systems Assay Parameters
Ammonia Ultra Plasma—Conventional and SI Units

Configure assay parameters — General Configure assay parameters — SmartWash

● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWash о Results о Interpretation
Assay: Amm Type: Photometric Version: † Assay: Amm
Number: 2969
COMPONENT REAGENT / ASSAY WASH Volume Replicates
Run controls for onboard reagents by:* Lot
Cuvette Trig** 10% Detergent B 345
● Reaction definition о Reagent / Sample о Validity checks
Reaction mode: Rate down ** Not required for ARCHITECT Software Version 7.00 and above.
Primary Secondary Read times
Wavelength: 340 / 660 Main: 3–7
Last required read: 7 Flex: ___ – ___
Absorbance range: 0.9000 – 1.9000 Color correction: ___ – ___ Ammonia Ultra Plasma—Conventional Units
Sample blank type: None
Configure assay parameters — Results
о Reaction definition ● Reagent / Sample о Validity checks о General о Calibration о SmartWash ● Results о Interpretation
R1 Assay: Amm Assay number: 2969
Reagent: AMM0S Reagent volume: 200 Dilution default range: Result units: µg/dL
Diluent: Saline Water volume: ___ Low-Linearity: 8
Diluent dispense mode: Type 0 Dispense mode: Type 0 High-Linearity: 1700
Gender and age specific ranges:
Diluted Default GENDER AGE (UNITS) NORMAL EXTREME
Dilution name Sample sample Diluent Water Dilution factor dilution
Either 0 – 130 (Y) 31 – 123
STANDARD : 35.0 ___ ___ ___ = 1:1.00 ●
DIL 1 : 17.5 ___ ___ ___ = 1:1.85 о
________ : ___ ___ ___ ___ = ___ о

о Reaction definition о Reagent / Sample ● Validity checks Configure result units

Reaction check: None Assay: Amm
Version: †
Result units: µg/dL
Rate linearity %: ___ Decimal places: 0 [Range 0 – 4]
Correlation factor: 1.0000
Intercept: 0.0000
Configure assay parameters — Calibration
о General ● Calibration о SmartWash о Results о Interpretation
Assay: Amm Calibration method: Linear
Ammonia Ultra Plasma—SI Units
● Calibrators о Volumes о Intervals о Validity checks Configure assay parameters — Results
Calibrator set: Calibrator level: Concentration: THIS PAGE INTENTIONALLY LEFT BLANK
AmmCA Blank: Water 0‡ о General о Calibration о SmartWash ● Results о Interpretation
Cal 1: AmmCA1 †† Assay: Amm Assay number: 2969
Replicates: 3 [Range 1 – 3] Dilution default range: Result units: µmol/L
Low-Linearity: 4.70
High-Linearity: 997.90
Gender and age specific ranges:
о Calibrators ● Volumes о Intervals о Validity checks GENDER AGE (UNITS) NORMAL EXTREME
Calibrator: AmmCA Diluted Either 0 – 130 (Y) 18.20 – 72.20‡‡
Calibrator level Sample sample Diluent Water
Blank: Water 35.0 ___ ___ ___
Cal 1: AmmCA1 35.0 ___ ___ ___

Configure result units

о Calibrators о Volumes ● Intervals о Validity checks Assay: Amm
Calibration intervals: Version: †
Full interval: 24 (hours) Result units: µmol/L
Calibration type: Decimal places: 2 [Range 0 – 4]
Adjust type: None Correlation factor: 1.0000
Intercept: 0.0000
о Calibrators о Volumes о Intervals ● Validity checks
Blank absorbance range: -0.0150 – 0.0150
Span: Blank – Blank
Span absorbance range: _____ – _____
Expected cal factor: 0.00
Expected cal factor tolerance %: 0

† Due to differences in instrument systems and unit configurations, version numbers may vary.
* Parameter is available in ARCHITECT Software Version 7.00 and above.
‡ Displays the number of decimal places defined in the decimal places parameter field.
†† Refer to the concentration specified in the REAGENTS section of this package insert. In ARCHITECT software version 5.00 and above,
these values are defined on the Configure calibrator set screen.
‡‡ The NORMAL range in SI Units was calculated by multiplying the NORMAL range in Conventional Units by the conversion factor of 0.587.

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