Relion Ketone Strips Owner S Manual Bayer — Reagent

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SSUUMMMMAARRYY AANNDD EEXXPPLLAANNAATTIIOONN::

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.

CCHHEEMMIICCAALL PPRRIINNCCIIPPLLEESS OOFF TTHHEE PPRROOCCEEDDUURREE::

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.

RREEAAGGEENNTTSS::

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

WWAARRNNIINNGGSS AANNDD PPRREECCAAUUTTIIOONNSS::

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).

SSTTOORRAAGGEE AANNDD HHAANNDDLLIINNGG::

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. DDoo nnoott uussee pprroodduucctt

((ooppeenneedd oorr uunnooppeenneedd)) aafftteerr eexxppiirraattiioonn ddaattee.. UUssee

ooff

ssttrriippss bbeeyyoonndd tthhee eexxppiirraattiioonn ddaattee mmaayy yyiieelldd

llooww rreessuullttss..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.

SSPPEECCIIMMEENN CCOOLLLLEECCTTIIOONN AANNDD PPRREEPPAARRAATTIIOONN::

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.

RRE

ESSUULLTTSS::

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.

IIFFTTEESSTTRREESSUULLTTSSSSEEEEMMQQUUEESSTTIIOONNAABBLLEE::

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. IIff aa pprroobblleemm ccaannnnoott bbee

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EEXXPPEECCTTEEDD VVAALLUUEESS::

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

LLIIMMIITTAATTIIOONNSS OOFF PPRROOCCEEDDUURREESS::

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.

SSPPEECCIIFFIICC PPEERRFFOORRMMAANNCCEE CCHHAARRAACCTTEERRIISSTTIICCSS::

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.

AAVVAAIILLAABBIILLIITTYY::

KETONE Reagent Strips in bottles of 50 strips

(#2523) are available only at Wal-Mart and SAM’s

Club pharmacies.

RREEFFEERREENNCCEESS::

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.

KKeettoonnee RReeaaggeenntt SSttrriippss//TTeesstt IInnffoorrmmaattiioonn aanndd PPrroocceedduurree

RReeaaggeenntt SSttrriippss ffoorr UUrriinnaallyyssiiss

AN13216A USA © 2004 Bayer HealthCare LLC Rev. 7/04

Manufactured by:

Bayer HealthCare LLC

Mishawaka, IN 46544

WWHHYY DDOO II NNEEEEDD TTOO TTEESSTT FFOORR

KKEETTOONNEE??

Ketone is a substance which is usually not

harmful when found in small amounts in

the urine. This could happen in dieting and,

when identified, gives you information on

carbohydrate and fat metabolism.

However, when you have too much of

this substance in your body it can be

dangerous and especially dangerous for a

person with diabetes.

If you are a person with diabetes, you may

produce ketones in urine whether you are

insulin dependent (Type I) or non-insulin

dependent (Type II). A person with Type I

diabetes is more likely to spill ketones in

the urine because they are more likely to

burn too much fat.

If you burn too much fat and produce a lot

of ketones, your diabetes may be out of

control. Then you may develop a complica-

tion called diabetic KETOACIDOSIS. This

can lead to a coma. You need to take fast

action when you see the ketone warning

signal. You should contact your doctor or

diabetes educator immediately. Your doctor

or educator can tell you how to change your

medication/insulin dose or your food intake

to bring your diabetes back into control and

to prevent ketoacidosis.

WWHHEENN SSHHOOUULLDD II TTEESSTT FFOORR KKEETTOONNEE??

1. When you have a cold, the flu or any

other kind of illness.

2. When your urine sugar test results show

you are spilling large amounts of sugar

(2% or more for two or more tests in a

row or several days in a row).

3. When you “feel” the signs of high blood

sugar (over 240 mg/dL) or when your

blood sugar is well over the range your

doctor or educator has set for you (if

you do blood glucose monitoring).

4. When you are under stress e.g., at

home, at school, at work, or on a

vacation.

5. Regularly during pregnancy.

HHOOWW DDOO II DDOO TTHHEE TTE

ESSTT??

Materials needed:

• KETONE Reagent Strips

• Timer or watch with second hand

1. Remove the strip from bottle. RReeppllaaccee

tthhee ccaapp iimmmmeeddiiaatteellyy aanndd ttiigghhttllyy..))

Do

not

touch the test area of the strip.

Check the EXP. DATE printed on the

bottle label. If the date has passed,

discard and retest with test strips

from a new bottle. If the bottle has

been opened, check the date you

recorded when you first opened the

bottle and if 6 months have passed,

throw the test strips away and use a

new bottle of KETONE Reagent Strips.

DDoo nnoott uussee pprroodduucctt ((ooppeenneedd oorr

uunnooppeenneedd)) aafftteerr eexxppiirraattiioonn ddaattee.. UUssee

ooff ssttrriippss bbeeyyoonndd tthhe

e eexxppiirraattiioonn ddaattee

mmaayy yyiieelldd llooww rreessuullttss..

2. Dip the test end of the strip into a

fresh urine sample and

remove it immediately

(drawing edge of strip

against the rim of the

urine container to remove

excess urine), or pass

the test end of the strip

through a stream of urine.

3. Begin timing.

4. AT EXACTLY 15 SECONDS, match the

reagent area to the ketone color chart.

Ignore color changes that occur after

15 seconds.

5. Record the result.

NNOOTTEE:: If the test shows a moderate or

large amount of ketone, call your doctor

or diabetes educator.

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-Care Center for

advice on testing technique and results.

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