Abaxis VetScan UA10 Руководство

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PLEASE CAREFULLY READ THIS PACKAGE INSERT BEFORE USE.

For Veterinary Use Only. For Use with the VetScan UA Analyzer.

INTENDED USE

The VetScan UA10 urine reagent strips provide tests for the semi-quantitative

measurement of leukocytes, ketones, nitrite, urobilinogen, bilirubin, glucose,

protein, specific gravity, pH, and blood in veterinary urine samples. UA10 strips

are to be read with the VetScan UA analyzer only. Manual reading of the strips is

not recommended. Not for human diagnostic use.

SUMMARY

VetScan UA10 urine reagent strips consist of a plastic strip affixed with reagent

paper pads and a calibration pad. This feature facilitates measurement of

multiple urine chemistries in a single analysis. The calibration pad, which is not

impregnated with reagents, allows automatic analyzer interference correction

to the natural color of urine to obtain accurate results.

TEST PRINCIPLES AND LIMITATIONS

Leukocytes (LEU): This test reveals the presence of granulocyte esterases.

These esterases cleave an indoxyl ester, and the indoxyl so liberated reacts

with a diazonium salt to produce a violet dye.

Leukocyte esterase results may be positive in the absence of observable

cells if the leukocytes have lysed. Positive results may occasionally be found

with random specimens from females due to contamination of the specimen

by vaginal discharge. Elevated glucose concentrations (1000 mg/dL or

≥ 55 mmol/L) or high specific gravity may cause decreased test results. The

presence of cephalexin, cephalothin, or tetracycline may cause decreased

reactivity, and high levels of the drug may cause a false negative reaction.

The test area does not react with intact lymphocytes. Reactivity may also

vary with temperature.

Ketones (KET): The test is based on the principle of Legal's test and is more

sensitive to acetoacetic acid than to acetone. The reagent area does not react

with β-hydroxybutyric acid. Some high specific gravity/low pH urines may give

reactions up to and including Trace. Normal urine specimens usually yield

negative results with this reagent. False positive results (Trace) may occur with

highly pigmented urine specimens.

Nitrite (NIT): The test is based on the principle of Griess's test and is specific

to nitrite. Any degree of uniform pink color development should be interpreted

as a positive. The presence of nitrite indicates the presence of 10

organisms per mL, but color development is not proportional to the number

of bacteria present. A negative result does not in itself prove that there is no

significant bacteriuria. Negative results may occur when urinary tract infections

are caused by organisms which do not contain reductase to convert nitrate to

nitrite; when urine has not been retained in the bladder long enough (4hrs -

8hrs) for reduction of nitrate to occur; or when dietary nitrate is absent, even if

organisms containing reductase are present and bladder incubation is ample.

Ascorbic acid concentrations of 25 mg/dL (1.4 mmol/L) or greater may cause

false negative results with specimens containing nitrite ion concentrations of

43 μmol/L or less.

Urobilinogen (URO): This test is based on the Ehrlich reaction. This test pad

will detect urobilinogen in concentrations as low as 3 μmol/L (approximately

0.2 Ehrlich unit/dL) in urine. The test pad may react with interfering substances

known to react with Ehrlich's reagent. Excreted pigments and medications that

have an intrinsic red coloration in acidic medium may produce false positive

results. This test is inhibited by elevated concentrations of formaldehyde. Strip

reactivity increases with temperature; the optimum temperature is 72-79 °F

(22-26 °C). The absence of urobilinogen cannot be determined with this test.

Bilirubin (BIL): This test is based on the coupling of bilirubin with diazonium

salt in an acid medium. Normally no bilirubin is detectable in urine by

even the most sensitive methods. Even trace amounts of bilirubin are

sufficiently abnormal to require further investigation. Some urine constituents

(medications, urinary indicants) may produce a yellowish or reddish

discoloration of the test paper that may interfere with interpreting the result.

Ascorbic acid concentrations of 25 mg/dL (1.4 mmol/L) or greater may also

cause false negatives.

Protein (PRO): The test is based on the principle of the protein error of a pH

indicator. The reagent area is more sensitive to albumin. An elevated pH (up

to 9.0) may affect the test. The residues of disinfectants containing quaternary

ammonium groups or chlorhexidine present in the urine vessel may lead to a

false positive result.

Glucose (GLU): The test is based on the specific glucose oxidase/peroxidase

reaction. The test is specific for glucose. No substance excreted in urine other

than glucose is known to give a positive result. False positive reactions may be

caused by hypochlorite or peroxide (bleach, cleaning agents). Ascorbic acid

VetScan UA10

Urine Test Strips

ENGLISH

of more than 1.4 mmol/L and/or high ketone concentrations (80 mg/dL or

8 mmol/L) may cause false negatives for specimens containing small amounts

of glucose (100 mg/dL or 5.5 mmol/L). The reactivity of the glucose test

decreases as the specific gravity (SG) of the urine increases. Reactivity may

also vary with temperature.

Specific Gravity (SG): This test contains a detergent and bromothymol blue

that indicates the presence of ionic constituents in the urine by changing color

from green to yellow. The specific gravity test permits determination of urine

specific gravity between 1.000 and 1.060. In general, it correlates within 0.005

with values obtained with the refractive index method. Strips are automatically

adjusted for pH by the analyzer when pH ≥ 7.0 or pH ≤ 5.0. Highly buffered

alkaline urine may cause low readings relative to other methods. Elevated

specific gravity readings may be obtained in the presence of very high

quantities of protein (500 mg/dL, 5 g/L).

Blood (BLD): Hemoglobin and myoglobin catalyze the oxidation of

the indicator by means of organic hydroperoxide contained in the test

paper. This test is highly sensitive to hemoglobin and thus complements

the microscopic examination for the presence of red blood cells (RBC).

(Hemoglobin concentration of 150 - 620 μg/L (9.31x10

is approximately equivalent to 5-15 intact red blood cells per microliter.) The

sensitivity of this test may be reduced in urine with high specific gravity. The

test is equally sensitive to myoglobin as it is to hemoglobin. Captopril and

Etodolac may also cause decreased reactivity. Blood is often found in the

urine of intact females in the proestrus stage. Certain oxidizing contaminants,

such as hypochlorite, may produce false positive results. Microbial peroxidase

associated with a urinary tract infection may cause a false positive reaction.

Ascorbic acid concentrations of 24.66 mg/dL (1.4 mmol/L) or greater may

cause false negatives at the trace blood levels.

pH: This test contains a mixed indicator which assures a marked change in

colour between pH 5.0 and pH 9.0.

REAGENTS COMPOSITION

Based on the dry weight content of each pad in 100 strips:

Leukocytes: indoxyl ester 1.4 mg; diazonium salt 0.7 mg.

Ketone: sodium nitroprusside 30.0 mg.

Nitrite: arsanilic acid 0.7 mg; N-(naphthyl)-ethylenediammonium

dihydrochloride 0.5 mg.

Urobilinogen: fast blue B salt 1.2 mg.

Bilirubin: 2,4-dichlorobenzene diazonium 14.3 mg.

Protein: tetrabromphenol blue 0.4 mg.

Glucose: glucose oxidase 800 I.U; peroxidase 200 I.U; 4-aminoantipyrine

0.1 mg.

Specific Gravity: bromothymol blue 0.4 mg; sodium poly methyl vinyl acetate

or more

maleic 16.0 mg.

Blood: cumene hydroperoxide 35.2 mg; 3,3',5,5'-tetramethylbenzidine 2.0 mg.

pH: bromocresol green 0.2 mg; bromxylenol blue 3.3 mg.

INSTRUCTIONS FOR USE

1. Additional materials required: VetScan UA urine analyzer, absorbent

lint-free tissue, dropper pipette (optional), disposable gloves, UA printer

(if printout desired, optional). Consult the VetScan UA User's Manual for

more detailed information.

2. Acquire a urine sample by any of the three methods below:

a. Cystocentesis

b. Catheter

c. Mid-stream urine sample

3. Place the VetScan UA analyzer on a stable, flat surface in a room at room

temperature (59-77 °F, 15-25 °C).

4. Remove a strip from the tube and immediately recap the tube. Do not

touch pads on the strip. Place the strip with pads facing up on a clean

paper towel or tissue.

5. Start a test on the Vetscan UA by selecting Strip Type as UA10, select the

Species and enter the Patient ID (PID). Then touch the Test button (Test

Tube icon). A timer will appear onscreen and a beep will sound in several

seconds. The application of urine and blotting in steps 6-10 must be

performed within 30 seconds.

6. Thoroughly mix the fresh, room temperature (59-77 °F, 15-25 °C) urine

sample immediately prior to testing by inverting the syringe or tube/

container multiple times.

7. Quickly apply the urine sample to the strip. The urine may be applied to

the strip by either of two methods:

a. Dip the UA10 strip into urine sample, completely immersing all the

pads. The sample tube of urine should be deeper than 88 mm. Be sure

that all pads are completely wetted. Remove the strip after 2 seconds.

– 3.85 x10

mmol/L)