ReliOn Ketone Test Strips Owner's Manual

ReliOn Healthcare Owner's Manual - Ketone Test Strips.
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SUMMARY AND EXPLANATION:

The strips provide a fast, convenient way of testing urine
for the presence and concentration of acetoacetic acid
(ketone). This substance when found in the urine provides
information on carbohydrate and fat metabolism.1,2

Acetoacetic acid can be found in the urine from
diabetics and is more commonly referred to as a
“ketone body.” Use of KETONE Reagent Strips can
alert you and your doctor or diabetes educator to
changes in your condition for which adjustments 
in your diet and/or medication may be needed.
Carefully follow the testing schedule your doctor or
educator establishes.

CHEMICAL PRINCIPLES OF THE PROCEDURE:

The ketone test is specific for acetoacetic acid and 
is based on the development of colors ranging from 
buff-pink to maroon when acetoacetic acid reacts
with nitroprusside.

REAGENTS:

7.1% w/w sodium nitroprusside; 92.9% w/w buffer.

WARNINGS AND PRECAUTIONS:

KETONE Reagent Strips are for 

in vitro diagnostic

use. They have been determined to be nonhazardous
under the guidelines issued by OSHA in 29CFR
1910.1200(d).

STORAGE AND HANDLING:

Never use KETONE Reagent Strips past the
expiration date printed on the bottle label.

To keep KETONE Reagent Strips fresh, follow these
suggestions carefully. Keep your finger or other
objects from touching the reagent area before testing.
Store at room temperatures between 59°– 86°F
(15°– 30°C). Do not store the bottle in direct sunlight.

Keep unused reagent strips in the original bottle 
with the cap tightly closed. Always replace the cap
immediately and tightly after removing a strip. A new
bottle of strips can be used for six months after being
first opened. Always write the date you first opened
the bottle on the bottle label. Do  not  use  product
(opened  or  unopened)  after  expiration  date.  Use
of  strips  beyond  the  expiration  date  may  yield
low  results. Never transfer reagent strips to another
bottle. Do not remove desiccant from bottle. The
desiccant absorbs moisture and keeps the strips dry.
Never put cotton or other materials in the bottle. If
the reagent area is ever discolored or darkened, throw
the strip away and use a strip from a new bottle.

SPECIMEN COLLECTION AND PREPARATION:

Collect fresh urine in a clean, dry container and test
it as soon as possible, or alternatively, pass the
reagent pad through the urine stream. If testing
cannot be done within an hour after collecting a urine
specimen, refrigerate the specimen immediately and
let it return to room temperature before testing.

RESULTS:

Results with KETONE Reagent Strips are obtained
directly from comparison to the Color Chart. The
color blocks represent nominal values; actual values
will vary around the nominal values.

Ketone results are read from the Color Chart as 
negative or varying degrees of positive which indicate
the relative amounts of ketone (acetoacetic acid)
present. The color blocks represent Negative, Trace
(5 mg/dL), Small (15 mg/dL), Moderate (40 mg/dL)
and Large (80–160 mg/dL). Proper read time is
critical for optimal results.

The ketone reagent area is most accurate when testing
urines of specific gravity between 1.010 and 1.020.

IF TEST RESULTS SEEM QUESTIONABLE:

1. Check the EXPIRATION DATE printed on the

bottle label. If the date has passed, discard and
retest with strips from a new bottle. Check the
date you first opened the bottle and if 6 months
have passed, throw the strips away and use a
new bottle of KETONE Reagent Strips.

2. Test the urine again with a strip from a new bottle

and compare results. If  a  problem  cannot  be
identified  or  corrected,  call  our  Customer
Service Department, toll free 1- 800-348- 8100
or  consult  your  doctor,  diabetes  educator,
pharmacist or Self Testing Center for advice
on testing technique and results.

EXPECTED VALUES:

Normal urine specimens ordinarily yield negative
results with the KETONE reagent area. Detectable
levels of ketone may occur in urine during physiological
stress conditions such as fasting, pregnancy and
frequent strenuous exercise.3,5 In ketoacidosis,
starvation or other abnormalities of carbohydrate or
fat metabolism, ketones may appear in urine in large
amounts before serum ketone is elevated.6

LIMITATIONS OF PROCEDURES:

As with all laboratory tests, definitive diagnostic or
therapeutic decisions should not be based on any
single result or method. KETONE results should
never be used as the sole basis for adjusting
insulin dosage.

Substances that cause abnormal urine color, such 
as drugs containing azo dyes (e.g., Pyridium®*, 
Azo Gantrisin®*, Azo Gantanol®*), nitrofurantoin
(Macrodantin®*, Furadantin®*), and riboflavin, may
affect the readability of the ketone reagent area on
the KETONE Reagent Strips. The color development
on the reagent pad may be masked, or a color
reaction may be produced on the pad that could be
interpreted as a false positive.

False positive results (Trace or less) may occur 
with highly pigmented urine specimens or those
containing large amounts of levodopa metabolites.
Compounds such as mesna (2-mercaptoethane
sulfonic acid) that contain sulfhydryl groups may
cause false positive results or an atypical color
reaction.

SPECIFIC PERFORMANCE CHARACTERISTICS:

Specific performance characteristics are based on
clinical and analytical studies. In clinical specimens,
the sensitivity depends upon several factors: the
variability of color perception; the presence or absence
of inhibitory factors typically found in urine, the
specific gravity, and the pH (see LIMITATIONS OF
PROCEDURES section); and the lighting conditions
under which the product is read. Because the 
color of each reagent area changes as the 
analyte concentration increases, the percentage of
specimens detected as positive will increase with the
analyte concentration.

Each color block represents a range of values.
Because of specimen and reading variability, speci-
mens with analyte concentrations that fall between
nominal levels may give results at either level.
Results at levels greater than the second positive
level will usually be within one level of the true
concentration.

The test reacts with acetoacetic acid in urine. It 
does not react with acetone or beta-hydroxybutyric
acid. In a majority of cases, the reagent area detects
5 to 10 mg/dL acetoacetic acid. Some high specific
gravity-low pH urines may give reactions up to and
including Trace (5 mg/dL). Clinical judgment is needed
to determine the significance of reactions up to and
including Trace.

AVAILABILITY:

KETONE Reagent Strips in bottles of 50 strips
(#2523) are available only at Wal-Mart and SAM’s
Club pharmacies.

REFERENCES:

1. Cecil, R. L. and Loeb, R. F.: A Testbook of Medicine, W. B. Saunders,

Co., Philadelphia, 1959, 10th ed., pp 618-619.

2. Engel, F. L. and Amatruda, T. T.: Ann. N. Y. Acad. Sci. 104, Art 2, 753-771

(1963).

3. McGarry, J. D., Lilly, Lecture 1978: New Perspectives in the Regulation of

Ketogenesis. 

DIABETES 28, May, 1978, 517-523.

4. Williamson, D. H.: Physiological ketoses, or why ketone bodies?

Postgraduate Medical Journal (June Suppl. 1971), 371-375.

5. Paterson, P., Sheath, J., Pincus, T. and Wood, C.: Maternal and Fetal

Ketone Concentrations in Plasmas and Urine, 

The Lancet: April 22, 1967,

862-865.

6. Fraser, J., Fetter, M.C., Mast, R. L. and Free, A. H.: Studies with a Simplified

Nitroprusside Test for Ketone Bodies in Urine, Serum, Plasma and Milk,
Clin. Chem. Acta II (1965) 376-378.

* Trademarks

Pyridium® is a registered trademark of Parke-Davis.

Azo Gantrisin® and Azo Gantanol® are registered trademarks of Roche
Laboratories.

Macrodantin® and Furadantin® are registered trademarks of Procter &

Gamble Pharmaceuticals, Inc.

Ketone Reagent Strips/Test Information and Procedure

Reagent Strips for Urinalysis

AN13216A   USA

© 2004 Bayer HealthCare LLC

Rev. 7/04

Manufactured by:
Bayer HealthCare LLC
Mishawaka, IN 46544

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