INTENDED USE
GB
Urine test strips for the rapid semi-quantitative determination of
ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite,
pH-value, protein, specic gravity and urobilinogen in human urine.
The CombiScreen
SUMMARY AND EXPLANATION
Urine test strips are semi-quantitative test systems used to
measure certain analytes in urine. These measurements are used
in the screening for renal, hepatic and metabolic disorders as well
as urinary tract infection of bacterial origin.
Since ascorbic acid in urine might interfere with the reaction of
some parameters, some CombiScreen
test pad which indicates the level of ascorbic acid in the urine.
The CombiScreen
protection for the blood and the glucose test pad.
This package insert describes all types of CombiScreen
test strips listed in the order information. All CombiScreen
test strips may be read visually, and the system urine test strips
may additionally be evaluated instrumentally. Refer to the carton
and label for specic parameter combination on the product you
are using.
TEST PRINCIPLE
Ascorbic acid: The test is based on the discoloration of Tillman’s
reagent. In the presence of ascorbic acid, the color changes from
grey-blue to orange.
Bilirubin: A red azo compound is obtained in the presence of acid
by coupling of bilirubin with a diazonium salt. The presence of
bilirubin leads to a color of red-orange peach.
Blood: The test is based on the pseudo-peroxidative activity of
hemoglobin and myoglobin, which catalyze the oxidation of an
indicator by an organic hydroperoxide and a chromogen producing
a green color. Intact erythrocytes are reported by punctual
colorations on the test pad, whereas hemoglobin and myoglobin
are reported by a homogeneous green coloration.
Glucose: The test is based on the glucose oxidase-peroxidasechromogen reaction. The presence of glucose leads to a color
change from yellow via lime green to dark teal.
Ketones: The test is based on the reaction of acetone and
acetoacetic acid with sodium nitroprusside in alkaline solution to
give a violet colored complex (Legal‘s test).
Leucocytes: The test is based on the esterase activity of
granulocytes. This enzyme cleaves heterocyclic carboxylates. If
the enzyme is released from the cells, it reacts with a diazonium
salt producing a violet dye.
Nitrite: The test is based on the principle of the Griess reaction.
Any degree of pink-orange coloration should be interpreted as a
positive result.
pH: The test paper contains pH indicators, which clearly change
color between pH 5 and pH 9 (from orange to green to turquoise).
Protein: The test is based on the „protein error“ principle of an
indicator. The test is especially sensitive in the presence of
albumin. Other proteins are indicated with less sensitivity. The
presence of proteins leads to a color change from yellowish to
mint green.
Specic Gravity: The test is based on a color change of the
reagent from blue green to greenish yellow depending on the
concentration of ions in the urine.
Urobilinogen: The test is based on the coupling of urobilinogen
with a stabilized diazonium salt to a red azo compound. The
presence of urobilinogen leads to a color change from light to
dark pink.
REAGENTS
Ascorbic acid: 2,6-dichlorophenolindophenol 0.7 %
Bilirubin: diazonium salt 3.1
Blood: tetramethylbenzidine-dihydrochloride 2.0
isopropylbenzol-hydroperoxide 21.0 %
Glucose: glucose oxidase 2.1
hydrochloride 5.0
Ketones: sodium nitroprusside 2.0 %
Leucocytes: carboxylic acid ester 0.4
Nitrite: tetrahydrobenzo[h]quinolin-3-ol 1.5 %; sulfanilic acid 1.9%
pH: methyl red 2.0 %; bromothymol blue 10.0%
Protein: tetrabromophenol blue 0.2
Specic Gravity: bromothymol blue 2.8
Urobilinogen: diazonium salt 3.6 %
WARNING AND PRECAUTIONS
For In Vitro Diagnostic Use.
For safe handling of urine test strips and for avoiding contact
with potentially infectious substances, please follow the general
working instructions for laboratories. Do not touch the test pads!
Avoid ingestion and contact with eyes and mucous membranes.
Keep away from children. Disposal of used test strips should be
in accordance with local regulations. The material safety data
sheet is available for download from our homepage http://www.
analyticon-diagnostics.com.
In case any serious incident has occurred in relation to the
device, please report to the manufacturer and, if applicable, to the
competent authority of the country in which the users and/or the
patients established themselves.
INDICATIONS OF DETERIORATION
Do not use discolored urine test strips. External inuences such as
humidity, light and extreme temperatures can cause a discoloration
of test pads and may indicate deterioration.
STORAGE AND STABILITY
Store the tubes in a cool and dry place (storage temperature
2–30
humidity and extreme temperatures. The urine test strips can be
used until the given expiry date if stored and handled as specied
in the package insert.
SPECIMEN COLLECTION AND PREPARATION
Testing of fresh, native, well-mixed and non-centrifuged urine is
recommended. Protect the samples from light. First morning urine
is preferable and shall be tested within 2 hours. If immediate
testing is not applicable, store samples at 2–4°C. Allow the
sample to reach room temperature (15–25°C) and mix them
before testing.
Collection tubes must be clean, dry and free from detergents,
biocides or disinfectants. Do not add preservatives.
PROCEDURE
• Use fresh, well-mixed native urine.
• Remove only the number of urine test strips intended to be used
for measurement, and immediately close the vial again tightly
with the original cap.
Dip the urine test strip shortly (approx. 1–2 seconds) into the
•
well-mixed urine. Make sure that all test pads are immersed in
the sample.
• Wipe the edge of the strip on the rim of the sample container to
remove excess urine.
•
Dab the edge of the urine test strip on an absorbent paper towel.
Visual evaluation: To prevent interaction of adjacent test
•
pads, hold the urine test strip in a horizontal position during
incubation. Compare the test pads on the urine test strip with
the corresponding color chart on the vial 60 seconds (60–120
seconds for leucocytes) after immersion. Color changes that
appear more than 2 minutes after immersion should not be
evaluated. Visual evaluation should be carried out in daylight (or
under daylight lamps), but not under direct sunlight. Any color
change that cannot be assigned to the color chart on the vial
label, or that is restricted to the rim of the test pads, is without
meaning and should not be used for interpretation.
•
Automated evaluation: For application, please read carefully
the detailed instructions for use of the instrument. Precise
agreement between visual and automated evaluation is not
always possible due to the different spectral sensitivities of the
human eye and the optical system of the instrument.
MATERIALS PROVIDED
Package with CombiScreen® urine test strips.
MATERIALS REQUIRED BUT NOT PROVIDED
For the automated evaluation: Analyticon urine analyzer for the
CombiScreen
QUALITY CONTROL
Performance of urine test strips should be checked with appropriate
quality control materials (e.g. REF 93010: CombiScreen
Check; REF 93015: CombiScreen
internal guidelines of the laboratory and the local regulations. It
is recommended to perform control measurements after opening
a new vial of urine test strips or with a new batch of urine test
strips. Each laboratory is obliged to establish its own quality
control standards. It is necessary to compare the resulting color
development with the label, as some control materials may show
atypical color development.
RESULTS AND EXPECTED VALUES
Each laboratory should evaluate the transferability of the expected
values to its own patient population and, if necessary, determine
its own reference ranges.
The color changes of the test pads correspond to the analyte
concentrations described in Table 1.
For use as a preliminary screening test for
diabetes, liver diseases, hemolytic diseases,
urogenital and kidney disorders and meta
abnormalities.
®
urine test strips are only for professional use.
®
®
PLUS urine test strips include ascorbic acid
%
°C). Keep urine test strips protected from direct sunlight,
®
system urine test strips.
urine test strips include a
%
%; peroxidase 0.9 %; o-tolidine-
%; diazonium salt 0.2 %
%
%
®
Drop Check), according to the
bolic
®
urine
®
urine
%,
®
Dip
LIMITATIONS OF THE PROCEDURE
• In order to establish a nal diagnosis and prescribe an
appropriate therapy, the results obtained with urine test strips
need to be evaluated in combination with other medical results
and the patient’s medical history.
•
Not all effects of medicaments, drugs or their metabolic
products on the urine test strip are known. In case of doubt,
it is recommended to repeat the test after discontinuation of
the medication. However, a current medication should only be
stopped after respective instruction of the doctor.
Detergents, cleaning agents, disinfectants and preservatives
•
may interfere with the reaction on the test pads. Various colored
urine contents, especially high concentrations of hemoglobin (≥
5 mg/dL) or bilirubin (≥ 2 mg/dL), can lead to atypical coloration
on the test pads.
•
The content of the urine is variable (e.g. content of activators
or inhibitors and ion concentration in the urine), therefore the
reaction conditions are not constant. In rare cases, this may lead
to variations in the color of the test pad.
Bilirubin: Low or negative results may be caused by large
amounts of vitamin C or nitrite and by a prolonged exposure of
the sample to direct light. Increased concentrations of urobilinogen
may increase the sensitivity of the bilirubin test pad. Various urine
contents (e.g. urine indican) can lead to an atypical coloration. Regarding the metabolites of drugs, refer to urobilinogen.
Blood: Erythrocyte results of the urine test strip and the sediment
may vary as lysed cells cannot be detected by the sediment
analysis. False positive reactions can be caused by residuals of
peroxide containing cleansing agents, by formalin, or activities of
microbial oxidase due to infections of the urogenital tract.
Classic Line: High concentrations of ascorbic acid (vitamin C) can
cause false negative results.
PLUS Line: The inuence of ascorbic acid has been largely
eliminated. From a level at approx. 25 Ery/μl and above, even at
high concentrations of ascorbic acid normally no negative results
are observed.
Glucose: An inhibitory effect is caused by gentisic acid, a pH value
of <5 and a high specic gravity. False positive reactions can also
be induced by a residue of peroxide containing cleansing agents.
Classic Line: High concentrations of ascorbic acid (vitamin C) can
cause false negative results.
PLUS Line: The inuence of ascorbic acid has been largely
eliminated. From a glucose level at approx. 100
mmol/L) and above, even at high concentrations of ascorbic
(5.5
acid normally no negative results are observed.
Ketones: Phenylketones in higher concentrations produce
variable colors. The keton body β-Hydroxybutyric acid is not
detected. Phthalein compounds and derivatives of anthrachinone
interfere by producing a red coloration in the alkaline range which
may mask the coloration caused by ketones.
Leucocytes: Leucocyte results of the urine test strip and the
sediment may vary as lysed cells cannot be detected by the
sediment analysis. Strongly colored compounds in the urine
(e.g. nitrofurantoin) may disturb the color of the reaction.
Glucose or oxalic acid in high concentrations, or drugs containing
cephalexine, cephalothine or tetracycline can lead to weakened
reactions. False positive results may be caused by contamination
with vaginal secretion.
Nitrite: Negative results do not exclude signicant bacteriuria,
since not all infectious species are capable of nitrite production
(lack of nitrate reductase). In addition, high diuresis can reduce
the retention time of the urine in the bladder and can lead to
highly diluted urine which prevents the assimilation of detectable
concentrations of nitrite. Moreover, a diet with low nitrate content
and a high uptake of vitamin C can also cause false negative
results. False positive results may occur for stale urines, in which
nitrite has been formed by contamination of the specimen, and in
urines containing dyes (derivatives of pyridinium, beetroot). Red or
blue borders or edges which may appear must not be interpreted
as a positive result.
pH: Bacterial contamination and growth in the urine after sample
collection may lead to false results. Red borders which may appear
next to the nitrite eld must not be taken into consideration.
Protein: Highly alkaline urine samples (pH > 9), high specic
gravity, infusions with polyvinylpyrrolidone (blood substitute),
medicaments containing quinine and also disinfectant residues
in the urine sampling vessel containing quaternary ammonium
groups can lead to false positive results.
Specic Gravity: The color scale has been optimized for urine
with pH 6. Highly alkaline (pH > 8) urines lead to slightly lower
results, highly acidic (pH < 6) urines may cause slightly higher
results. Glucose and urea do not interfere with the test.
Urobilinogen: Higher concentrations of formaldehyde or
exposure of the urine to light for a longer period of time may lead
to lowered or false negative results. Beetroot or metabolites of
drugs which give a color at low pH (phenazopyridine, azo dyes,
p-aminobenzoic acid) may cause false positive results.
PERFORMANCE CHARACTERISTICS
The performance characteristics of the CombiScreen® urine
test strips have been determined on the basis of analytical
performance studies. The test performance of the urine test strips
was characterized by its agreement with commercially available
urine test strips.
Visual evaluation
Sensitivity
Ascorbic acid: 10–15 mg/dL, Bilirubin: >0.6 mg/dL (10 μmol/L),
Blood: >2 Ery/µL Classic / PLUS, Glucose: >40 mg/dL (2.2
mmol/L) Classic; >20 mg/dL (1.1 mmol/L) PLUS, Ketones: >5.4
mg/dL (0.5 mmol/L), Leucocytes: 15–20 Leu/µL, Nitrite: 0.05–0.1
mg/dL (11–22 μmol/L), Protein: >15 mg/dL, Urobilinogen: 1–2
mg/dL (16.9–33.8 µmol/L).
Test Performance (extended concordance)
Ascorbic acid: n.a., Bilirubin: 98.7–99.6 %, Blood: 99.6–100 %,
Glucose: 99.6–100
98.2
SG: 88.9–96.6
Automated evaluation (Urilyzer
Sensitivity
Ascorbic acid: 2.5–7 mg/dL, Bilirubin: 0.9–1.2 mg/dL (15.4–20.5
μmol/L), Blood: 3–7 Ery/µL, Glucose: 40–50 mg/dl (2.2–2.8
mmol/L) Classic, 28–32 mg/dl (1.6–1.8 mmol/L) PLUS, Ketones:
>2.5 mg/dL (0.3 mmol/L), Leucocytes: 15–20 Leu/µL, Nitrite:
>0.14 mg/dL (30.4 μmol/L), Protein: 20–25 mg/dL, Urobilinogen:
1.5–1.8 mg/dL (25.4–30.2 µmol/L).
Test Performance (extended concordance)
Ascorbic acid: 99.9–100 %, Bilirubin: 94.7–100 %, Blood: 89.3–
100
cytes: 93.1–100
87.4–100
n.a.: not applicable
Table 1: Expected values and measuring ranges of the different
urine test strip parameters:
Parameter
Ascorbic
acid
Bilirubin neg. Arbitrary neg., +, ++, +++
Blood neg. Arbitrary neg., +, ++, +++
Glucose norm. Arbitrary norm., +, ++, +++, ++++, 5+
Ketones neg. –
Leucocytes neg. Arbitrary neg., +, ++, +++
Nitrite neg. Arbitrary neg., pos.
pH pH 5–8 5, 6, 6.5, 7, 7.5*, 8, 9
Protein neg. –
Specic
Gravity
Urobilinogen
n.a.: not applicable; *For automated evaluation only; **Visual
evaluation only
SYMBOLS
%, Ketones: 100 %, Leucocytes: 96.9–
%, Nitrite: 100 %, pH: 99.6–100 %, Protein: 98.2–99.6 %,
%, Urobilinogen: 89.5–100 %.
®
100 Pro and 500 Pro)
%, Glucose: 98.8–100 %, Ketones: 97.8–100 %, Leuco-
%, Nitrite: 99.7–100 %, pH: 95.4–100 %, Protein:
%, SG: 55.7–99.7 %, Urobilinogen: 91.3–99,8 %.
Unit Measuring Range
Expected
Values
n.a. Arbitrary neg., +, ++
[mg/dL] neg., 20, 40
[g/L] neg., 0.2, 0.4
[mg/dL] neg., 1, 2, 4
[µmol/L] neg., 17, 35, 70
[Ery/µL] neg., 5–10, ~50, ~300
[mg/dL] norm., 50, 100, 250, 500,
1000
[mmol/L] norm., 2.8, 5.6, 14, 28, 56
Arbitrary neg., (+) [trace], +, ++, +++
trace
[mg/dL] neg., 10 [trace], 25, 100, 300
[mmol/L] neg., 1.0 [trace], 2.5, 10, 30
[Leu/µL] 0, ~25, ~75, ~500
Arbitrary neg., (+) [trace]**, +, ++, +++
trace
[mg/dL] neg., 15 [trace]**, 30, 100, 500
[g/L] neg., 0.15 [trace]**, 0.3, 1.0, 5.0
1.015–
1.025
norm. Arbitrary norm., +, ++, +++, ++++
In vitro diagnostics
product
The product complies with
European legislation
Follow the instructions
for use!
Use by Manufacturer
Permitted storage
temperature range
Distributor
1.000, 1.005, 1.010, 1.015,
1.020, 1.025, 1.030
[mg/dL] norm., 2, 4, 8, 12
[µmol/L] norm., 35, 70, 140, 200
mg/dL
Only single use
Batch identication
number
Item number
date of manufacture
Analyticon Biotechnologies GmbH
Am Muehlenberg 10
35104 Lichtenfels
Germany
www.analyticon-diagnostics.com
CombiScreen® PLUS
Urine Test Strips
CombiScreen
®
Urine Test Strips
GBFRDEITSEPTDK
FIPLNOCZTRGRES
NL
RU
Name Art.-No. Cont
Glucose
Ascorbic Acid
Ketones
Parameter
Protein
pH-Value
Blood
Nitrite
Leucocytes
Spec. Gravity
Bilirubin
Urobilinogen
CombiScreen® Plus – with ascorbic acid protection
Glu Plus 94501 50
Nitrit Plus 94506 50
3 Plus 94508 / 94108 50 / 100
5+Leuko Plus 94517 / 94117 50 / 100
5+N Plus 94535 / 94135 50 / 100
9 Plus 94115 100
9+Leuko Plus 94250 / 94200 50 / 100
10SL Plus 94120 100
5SYS Plus
7SYS Plus
11SYS Plus
CombiScreen
1)
1)
2)
94109 100
94110 / 94110A 100 / 150
94100 / 94150 / 94150BC3)100 / 150 / 150
®
classic line – without ascorbic acid protection
GP 93104 100
3 93108A 150
GAK 93107 / 93107A 100 / 150
GPK 93105 100
10SL 93120 / 93120A / 93120B 100 / 150 / 50
2)
11SYS
1)
System test strips to be used with Urilyzer® 100 Pro instruments
2)
System test strips to be used with CombiScan® and Urilyzer® 100/500 Pro instruments
3)
System test strips with barcode on the label
Text passages with grey background were changed in the latest revision of this package insert. / Grau hinterlegte Textpassagen wurden in der letzten Überarbeitung dieser Gebrauchsanweisung geändert. / Gråmarkerade delar av texten har ändrats sedan packsedelns senaste revision. / Tekstpassager med grå
baggrund er ændret i den seneste version af denne indlægsseddel. / Pakkausselosteessa harmaalla taustalla olevia tekstejä on muutettu viimeksi tehdyssä tarkistuksessa. / Tekstpassasjer med grå bakgrunn ble endret i den seneste revisjonen av dette pakningsvedlegget. / Bu paketin en son revizyonunda gri
arka planlı metin pasajları değiştirilmiştir. / Los pasajes de texto con fondo gris se cambiaron en la última revisión de este prospecto. / Les passages de texte sur fond gris ont été modiés dans la dernière révision de ce mode d’emploi. / I passaggi di testo con sfondo grigio sono stati modicati nell’ultima revisione
di questo foglietto illustrativo. / As passagens de texto com fundo cinza foram alteradas na última revisão deste folheto informativo. / Tekstgedeelten met een grijze achtergrond zijn aangepast tijdens de laatste revisie van deze bijsluiter. / Fragmenty tekstu na szarym tle zostały zmienione w najnowszej wersji
tej ulotki dołączonej do opakowania. / Části textu se šedým pozadím se změnily při poslední revizi této příbalové informace. / Τα αποσπάσματα κειμένου με γκρίζο φόντο τροποποιήθηκαν στην τελευταία αναθεώρηση του παρόντος ένθετου συσκευασίας. / Текст выделенный серым цветом был изменён в
последней версии этой инструкции по применению.
93100 / 93150 / 93050 100 / 150 / 50
2 sec.
60 sec. incubation time
References / Referenzen / Referenser / Referencer /
Viitteet / Referanser / Referanslar / Referencias /
Références / Riferimenti / Referências / Referenties /
Referencje / Reference / βιβλιογραφικές αναφορές /
Cправочный
Referenzbereiche für Kinder und Erwachsene von Heil/
Ehrhardt (Roche) [pH Referenz daraus entnommen];
oder alternativ aus „Textbook of Urinalysis and Body
Fluids“ von Landy J. McBride:
Kaplan L.A., Pesce A.J. Clinical chemistry. 3rd ed. St.
Louis: The CV Mosby Company, 1996.
PBA9342_16L_21_001_06.02_20221017
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