CombiScreen® DIP Check
Analyticon® Biotechnologies AG
Am Mühlenberg 10, 35104 Lichtenfels / Germany
(P93010_D-GB-F-I-ES-P-DK-NO-SE-FI_21_001_02.01_2019-01-30_Y525) S1/10
GB
Catalog No. 93010 2 x 15 mL Lot No. Y 525
Expiry 2020/05
Intended Use
FOR IN VITRO DIAGNOSTIC USE
CombiScreen® DIP Check is intended for use as an assayed quality control material for
various urinalysis reagent strips and qualitative hCG methods.
Summary and Explanation
The use of quality control materials to objectively monitor the accuracy and precision of
procedures is well established in clinical laboratories. CombiScreen® DIP Check is provided
at two levels to assist in the monitoring of analytical systems within the clinical range.
Product Description
CombiScreen® DIP Check is human urine-based containing constituents of human and
animal origin as well as purified chemicals. Preservatives and stabilizers have been added
to maintain product integrity. CombiScreen® DIP Check is a ready-to-use liquid control
requiring no reconstitution.
Warnings and Precautions
For in vitro diagnostic use.
accurate, they do not guarantee that all infected units will be detected. Because no known
test method can offer complete assurance the hepatitis B virus, hepatitis C virus, human
immunodeficiency virus (HIV) or other infectious agents are absent, all products containing
human source material should be considered potentially infectious and handled with the
same precautions used with patient specimens.
This product contains 0.09% sodium azide as a preservative. Sodium azide may react with
lead and copper plumbing to form potentially explosive compounds. Flush with excess water
upon disposal.
The material safety data sheet contains further safety-related information. It is available for
download from our homepage http://www.analyticon-diagnostics.com.
Indications of deterioration
If the controls are turbid or if any evidence of microbial growth or contamination is present,
the controls should be discarded. This should be done according to the local guidelines in
the same manner as for other biological specimens.
Storage and Stability
CombiScreen® DIP Check is stable until the expiration date on the tube label when stored
unopened at 2–8°C. Do not freeze.
Once opened, tubes of control are stable for 75 days when stored tightly capped at
2–8°C or 20 dipstick immersions have taken place, whichever occurs first.
CombiScreen® DIP Check may be stored for 30 days at 20–25°C.
Procedure
CombiScreen® DIP Check should be treated the same as patient specimens and run in
accordance with the instructions accompanying the test system (instrument, kit, or reagent)
being used. Allow the product to reach room temperature prior to use.
QC materials should be used in accordance with local, state, and/or federal regulations or
accreditation requirements.
Instructions
1. Gently invert the tube several times before sampling to ensure homogeneity. This is
2. For dipstick testing: remove the cap and dip the reagent strip in the tube as if it were a
3. Replace the cap immediately after use and store appropriately.
Materials provided
1x Control L1, 15 ml 1x Control L2, 15 ml
1x Kit insert
Limitations of the Procedure
CombiScreen® DIP Check should not be used past the expiration date on the tube label.
CombiScreen® DIP Check is a stabilized liquid product. To obtain consistent assay values,
CombiScreen® DIP Check requires storage and handling as detailed in Storage and
Stability.
Accurate and reproducible results are dependent upon properly functioning instruments and
reagents. The ranges given are intended only as a guideline. Each laboratory should
establish their own acceptable ranges and tolerance limits based on their test system.
Expected readings
The expected values printed in this insert were derived from replicate analyses of
representative samples of the product and are specific to this lot of CombiScreen® DIP
Check. Testing data used to establish the expected values were derived from multiple
instruments. All values have been assigned with manufacturer’s reagents available at the
time of assay. Subsequent instrument or reagent modifications may invalidate these
expected values. To request a faxed or emailed copy of the value assignment, contact your
local distributor or info@analyticon-diagnostics.com.
Human source material. Treat as potentially infectious.
Each donor unit used in the manufacture of this product has been tested by FDA
accepted methods and found non-reactive for the presence of HBsAg and
antibody to HIV-1/2, HCV and HIV-1 Ag. While these methods are highly
important to obtain reproducible results.
patient sample. In accordance with the manufacturer’s instructions, read the reagent
strips either visually or with an instrument reader.
For hCG testing: In accordance with the hCG test kit manufacturer’s instructions, use
controls as if they were patient specimens. For the control of confirmatory pregnancy
test kits, be sure to use the transfer pipette included in the kit to deliver the correct
sample amount to test device.
CombiScreen® DIP Check
Catalog No. 93010 2 x 15 mL Lot No. Y 525
Expiry 2020/05
Analyticon® Biotechnologies AG
Am Mühlenberg 10, 35104 Lichtenfels / Germany
(P93010_D-GB-F-I-ES-P-DK-NO-SE-FI_21_001_02.01_2019-01-30_Y525) S7/10
*) Repeated dipping may yield false positives.
**) Atypical color may occur.
Level N (L1)
Level P (L2)
Analyticon
Urilyzer® 100
Analyticon CombiScreen® Urine Test Strips
Analyte
Visual
Instrumental (Analyticon CombiScan® / Urilyzer®)
Level L1
Level L2
Level L1
Level L2
Ascorbic Acid
Negative
Negative
Negative – 20 mg/dl
Negative – 1+
Negative – 20 mg/dl
Negative – 1+
Bilirubin
Negative
1+ – 3+
Negative
1 – 4 mg/dl
17 – 70 µmol/l
1+ – 3+
Blood
Negative *)
10 – 300 Ery/µl
1+ – 3+
Negative *)
10 – 300 Ery/µl
1+ – 3+
Glucose
Normal
50 – 1000 mg/dl
2.8 – 56 mmol/l
Normal
50 – 1000 mg/dl
2.8 – 56 mmol/l
1+ – 5+
Ketones
Negative
(+) – 3+
Negative
10 – 300 mg/dl
1.0 – 30 mmol/l
(+) – 3+
Leucocytes
Negative
25 – 500 Leu/µl
Negative
25 – 500 Leu/µl
1+ – 3+
Nitrite
Negative *)
Positive
Negative *)
Positive
pH
5 – 6
7 – 9
5 – 7
6 – 9
Protein
Negative
30 – 500 mg/dl
Negative
30 – 500 mg/dl
0.3 – 0.5 g/l
1+ – 3+
Specific Gravity
1.020 – 1.030
1.000 – 1.015
1.015 – 1.030
1.000 – 1.030
Urobilinogen
Normal
2 – 12 mg/dl **)
35 – 200 µmol/l
Normal
2 – 12 mg/dl
35 – 200 µmol/l
1+ – 4+
CombiScreen® DIP Check
Catalog No. 93010 2 x 15 mL Lot No. Y 525
Expiry 2020/05
Analyticon® Biotechnologies AG
Am Mühlenberg 10, 35104 Lichtenfels / Germany
(P93010_D-GB-F-I-ES-P-DK-NO-SE-FI_21_001_02.01_2019-01-30_Y525) S8/10
Siemens Multistix® 10SG Urinalysis Reagent Strips
Analyte
Visual
Instrumental (Siemens Clinitek® Status® / Advantus®)
Level L1 (LOT# 1706185F)
Level L2 (LOT# 1706186D)
Level L1 (LOT# Y 525)
Level L2 (LOT# Y 525)
Ascorbic Acid
n.a.
n.a.
n.a.
n.a.
Bilirubin
Negative
1+ – 3+
Negative
1+ – 3+
Blood
Negative
Trace – 3+
Negative
Trace – 3+
Glucose
Negative
100 – ≥2000 mg/dl
Negative
100 – ≥1000 mg/dl
Trace – 3+
Ketones
Negative
5 – 160 mg/dl
Negative
5 – ≥160 mg/dl
Trace – 4+
Leucocytes
Negative
Trace – 3+
Negative
Trace – 3+
Nitrite
Negative
Positive
Negative
Positive
pH
5.0 – 6.0
6.5 – 8.5
5.0 – 6.5
7.0 – ≥9.0
Protein
Negative
Trace – ≥2000 mg/dl
Trace – 4+
Negative
Trace – ≥2000 mg/dl
Trace – 4+
Specific Gravity
1.020 – 1.030
1.000 – 1.020
1.015 – ≥1.030
≤1.005 – 1.020
Urobilinogen
Normal
2 – 8 mg/dl
Normal
1 – ≥8 mg/dl
Siemens Multistix PRO® 10SL Urinalysis Reagent Strips
Analyte
Visual
Instrumental (Siemens Clinitek Status® / Advantus®)
Level L1 (LOT# 1706185F)
Level L2 (LOT# 1706186D)
Level L1 (LOT# 1706185F)
Level L2 (LOT# 1706186D)
Blood
Negative
Trace – 3+
Negative – Trace
Trace – 3+
≤5 – ca. 200 Ery/µl
Creatinine
10 – 200 mg/dl
100 – 300 mg/dl
10 – 200 mg/dl
100 – ≥300 mg/dl
8.8 – ≥26.5 mmol/l
Glucose
Negative
100 – ≥2000 mg/dl
Negative
100 – ≥2000 mg/dl
5.5 – ≥111 mmol/l
Ketones
Negative
5 – 160 mg/dl
Negative
5 – ≥160 mg/dl
0.5 – ≥16.0 mmol/l
Trace – 4+
Leucocytes
Negative
Trace – 3+
Negative
Trace – 3+
15 – 500 Leu/µl
Nitrite
Negative
Positive
Negative
Positive
pH
5.0 – 6.5
6.5 – 8.5
5.0 – 6.5
6.5 – ≥9.0
Protein, High
Negative
30 – 2000 mg/dl
1+ – 4+
n.a.
n.a.
Protein, Low
Negative
15 mg/dl
n.a.
n.a.
Protein
n.a.
n.a.
Negative
15 – ≥2000 mg/dl
Trace – 4+
≤0.5 – 20.0 g/l
Protein:Creatinine
n.a.
n.a.
Normal
Abnormal
Specific Gravity
1.020 – 1.030
1.000 – 1.020
1.020 – ≥1.030
1.000 – 1.020
Siemens Clinitek® Microalbumin Urinalysis Reagent Strips
Analyte
Visual
Instrumental (Siemens Clinitek Status® / Advantus®)
Level L1 (LOT# 1706185F)
Level L2 (LOT# 1706186D)
Level L1 (LOT# Y 525)
Level L2 (LOT# Y 525)
Microalbumin
n.a.
n.a.
0 – 10 mg/l
30 – 150 mg/l
Creatinine
n.a.
n.a.
10 – 200 mg/dl
100 – 300 mg/dl
CombiScreen® DIP Check
Catalog No. 93010 2 x 15 mL Lot No. Y 525
Expiry 2020/05
Analyticon® Biotechnologies AG
Am Mühlenberg 10, 35104 Lichtenfels / Germany
(P93010_D-GB-F-I-ES-P-DK-NO-SE-FI_21_001_02.01_2019-01-30_Y525) S9/10
* Lateral Flow Test
Roche ChemStrip® Urinalysis Reagent Strips
Analyte
Visual (10SG, 10UA, 10MD)
Instrumental (Roche Urisys 1100® / 2400®)
Level L1 (LOT# 1706185F)
Level L2 (LOT# 1706186D)
Level L1 (LOT# 1706185F)
Level L2 (LOT# 1706186D)
Bilirubin
Negative
1+ – 3+
Negative
1 – 6 mg/dl
1+ – 3+
17 – 100 µmol/l
Blood
Negative
Trace – 250 Ery/µl
Negative
5 – 250 Ery/µl
Trace – 4+
Glucose
Normal
50 – 1000 mg/dl
Normal
50 – ≥1000 mg/dl
Trace – 4+
2.8 – ≥56 mmol/l
Ketones
Negative
1+ – 3+
Negative
5 – 150 mg/dl
Trace – 3+
0.5 – ≥15.0 mmol/l
Leucocytes
Negative
Trace – 2+
Negative
25 – 500 Leu/µl
Trace – 2+
Nitrite
Negative
Positive
Negative
Positive
pH
5.0 – 6.0
7.0 – 9.0
5.0 – 6.5
7.0 – 9.0
Protein
Negative
Trace – 500 mg/dl
Trace – 3+
Negative
15 – 500 mg/dl
Trace – 3+
0.15 – 5.0 g/l
Specific Gravity
1.015 – 1.030
1.000 – 1.020
1.015 – 1.030
1.000 – 1.020
Urobilinogen
Normal
1 – 12 mg/dl
Normal
1 – ≥8 mg/dl
1+ – 4+
16 – ≥128 µmol/l
Roche Combur10 Test® Urinalysis Reagent Strips
Analyte
Visual
Instrumental (Roche Urisys 1100® with Combur10 Test® UX)
Level L1 (LOT# 1706185F)
Level L2 (LOT# 1706186D)
Level L1 (LOT# 1706185F)
Level L2 (LOT# 1706186D)
Bilirubin
Negative
1+ – 3+
Negative
1 – 6 mg/dl
1+ – 3+
17 – 100 µmol/l
Blood
Negative
5 – 250 Ery/µl
1+ – 4+
Negative
Trace – 250 Ery/µl
Trace – 4+
Glucose
Normal
50 – 1000 mg/dl
1+ – 4+
Normal
50 – ≥1000 mg/dl
Trace – 4+
2.8 – ≥56 mmol/l
Ketones
Negative
10 – 150 mg/dl
1+ – 3+
Negative
15 – 150 mg/dl
1+ – 3+
0.5 – ≥15.0 mmol/l
Leucocytes
Negative
10 – 500 Leu/µl
1+ – 3+
Negative
25 – 500 Leu/µl
Trace – 3+
Nitrite
Negative
Positive
Negative
Positive
pH
5.0 – 6.0
7.0 – 9.0
5.0 – 6.5
7.0 – 9.0
Protein
Negative
30 – 500 mg/dl
1+ – 3+
Negative
Trace – 500 mg/dl
Trace – 3+
0.15 – 5.0 g/l
Specific Gravity
1.015 – 1.030
1.000 – 1.020
1.015 – 1.030
1.000 – 1.020
Urobilinogen
Normal
1 – 12 mg/dl
1+ – 4+
Normal
1 – ≥12 mg/dl
1+ – 4+
16 – ≥128 µmol/l
Qualitative Tests
Test
Level L1 (LOT# Y 525)
Level L2 (LOT# Y 525)
hCG*
Negative
Positive
CombiScreen® DIP Check
Catalog No. 93010 2 x 15 mL Lot No. Y 525
Expiry 2020/05
Analyticon® Biotechnologies AG
Am Mühlenberg 10, 35104 Lichtenfels / Germany
(P93010_D-GB-F-I-ES-P-DK-NO-SE-FI_21_001_02.01_2019-01-30_Y525) S10/10
Glossary (GB)
Glossar (DE)
Glossaire (F)
Glossario (I)
Glosario (ES)
Glossário (PT)
Ordlista (S)
Ordliste (N)
Level
Level
Niveau
Livello
Nivel
Nível
Nivå
Nivå
Ascorbic acid
Ascorbinsäure
Acide ascorbique
Acido ascorbico
Ácido ascórbico
Ácido ascórbico
Askorbinsyra
Asckorbinsyre
Bilirubin
Bilirubin
Bilirubine
Bilirubina
Bilirrubina
Bilirrubina
Bilirubin
Bilirubin
Blood
Blut
Sang
Sangue
Sangre
Sangue
Blod
Blod
Creatinine
Kreatinin
Créatinine
Creatinina
Creatinina
Creatinina
Kreatinin
Kreatinin
Glucose
Glukose
Glucose
Glucosio
Glucosa
Glicose
Glukos
Glukose
Ketones
Ketone
Cétones
Chetoni
Cetonas
Cetonas
Ketoner
Ketoner
Leucocytes
Leukozyten
Leucocytes
Leucociti
Leucocitos
Leucócitos
Leukocyter
Leukocytter
Microalbumin
Mikroalbumin
Microalbumine
Microalbumina
Microalbúmina
Microalbumina
Mikroalbumin
Mikroalbumin
Nitrite
Nitrit
Nitrite
Nitriti
Nitrito
Nitrito
Nitrit
Nitritt
pH
pH
pH
pH
pH
pH
pH
pH
Protein
Protein
Protéine
Proteine
Proteína
Proteína
Protein
Protein
Specific Gravity
Spezifisches
Gewicht
Gravité spécifique
Peso specifico
Densidad relativa
Gravidade
específica
Specifik vikt
Spesfikk vekt
Urobilinogen
Urobilinogen
Urobilinogène
Urobilinogeno
Urobilinógeno
Urobilinogênio
Urobilinogen
Urobilinogen
Normal
Normal
Normal
Normale
Normal
Normal
Normalt
Normalt
Negative
Negativ
Négatif
Negativo
Negativo
Negativo
Negativ
Negative
Positive
Positiv
Positif
Positivo
Positivo
Positivo
Positiv
Positiv
Visual
Visuell
Visuellement
Visivamente
Visualmente
Visualmente
Visuellt
Visuelt
Instrumental
Instrumentell
Instrumentalement
Strumentalmente
Instrumentalmente
Instrumentalmente
Instrumentellt
Instrumentelt
Qualitative
Qualitativ
Qualitatif
Qualitativo
Qualitativo
Qualitativo
Kvalitativ
Kvalitativ
Glossary (GB)
Ordliste (DK)
Sanasto (FIN)
Level
Niveau
Taso
Ascorbic acid
Ascorbinsyre
Askorbiinihappo
Bilirubin
Bilirubin
Bilirubiini
Blood
Blod
Veri
Creatinine
Kreatinin
Kreatiniini
Glucose
Glucose
Glukoosi
Ketones
Ketoner
Ketonit
Leucocytes
Leukocytter
Valkosolut
Microalbumin
Mikroalbumin
Microalbumin
Nitrite
Nitrit
Nitriitti
pH
pH
pH
Protein
Protein
Proteiini
Specific Gravity
Specifik vægt
Spesifinen paino
Urobilinogen
Urobilinogen
Urobilinogeenin
Normal
Normalt
Normaalisti
Negative
Negativ
Negatiivinen
Positive
Positiv
Positiivinen
Visual
Visuelt
Visuaalisesti
Instrumental
Instrumentalt
Välineellisesti
Qualitative
Kvalitativ
Laadullinen
Anmerkung: Grau hinterlegte Textpassagen wurden in der letzten Überarbeitung dieser Gebrauchsanweisung geändert.
Note: Text passages with grey background were changed in the latest revision of this package insert.
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