
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
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.
Analyticon CombiScreen® Urine Test Strips
Instrumental (Analyticon CombiScan® / Urilyzer®)
Negative – 20 mg/dl
Negative – 1+
Negative – 20 mg/dl
Negative – 1+
1 – 4 mg/dl
17 – 70 µmol/l
1+ – 3+
50 – 1000 mg/dl
2.8 – 56 mmol/l
50 – 1000 mg/dl
2.8 – 56 mmol/l
1+ – 5+
10 – 300 mg/dl
1.0 – 30 mmol/l
(+) – 3+
30 – 500 mg/dl
0.3 – 0.5 g/l
1+ – 3+
2 – 12 mg/dl **)
35 – 200 µmol/l
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
Instrumental (Siemens Clinitek® Status® / Advantus®)
100 – ≥1000 mg/dl
Trace – 3+
5 – ≥160 mg/dl
Trace – 4+
Trace – ≥2000 mg/dl
Trace – 4+
Trace – ≥2000 mg/dl
Trace – 4+
Siemens Multistix PRO® 10SL Urinalysis Reagent Strips
Instrumental (Siemens Clinitek Status® / Advantus®)
Trace – 3+
≤5 – ca. 200 Ery/µl
100 – ≥300 mg/dl
8.8 – ≥26.5 mmol/l
100 – ≥2000 mg/dl
5.5 – ≥111 mmol/l
5 – ≥160 mg/dl
0.5 – ≥16.0 mmol/l
Trace – 4+
Trace – 3+
15 – 500 Leu/µl
15 – ≥2000 mg/dl
Trace – 4+
≤0.5 – 20.0 g/l
Siemens Clinitek® Microalbumin Urinalysis Reagent Strips
Instrumental (Siemens Clinitek Status® / Advantus®)

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
Roche ChemStrip® Urinalysis Reagent Strips
Analyte
Visual (10SG, 10UA, 10MD)
Instrumental (Roche Urisys 1100® / 2400®)
1 – 6 mg/dl
1+ – 3+
17 – 100 µmol/l
5 – 250 Ery/µl
Trace – 4+
50 – ≥1000 mg/dl
Trace – 4+
2.8 – ≥56 mmol/l
5 – 150 mg/dl
Trace – 3+
0.5 – ≥15.0 mmol/l
25 – 500 Leu/µl
Trace – 2+
Trace – 500 mg/dl
Trace – 3+
15 – 500 mg/dl
Trace – 3+
0.15 – 5.0 g/l
1 – ≥8 mg/dl
1+ – 4+
16 – ≥128 µmol/l
Roche Combur10 Test® Urinalysis Reagent Strips
Instrumental (Roche Urisys 1100® with Combur10 Test® UX)
1 – 6 mg/dl
1+ – 3+
17 – 100 µmol/l
Trace – 250 Ery/µl
Trace – 4+
50 – ≥1000 mg/dl
Trace – 4+
2.8 – ≥56 mmol/l
15 – 150 mg/dl
1+ – 3+
0.5 – ≥15.0 mmol/l
25 – 500 Leu/µl
Trace – 3+
Trace – 500 mg/dl
Trace – 3+
0.15 – 5.0 g/l
1 – ≥12 mg/dl
1+ – 4+
16 – ≥128 µmol/l

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
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.