DRG International EIA-4394 Cystatin C Human ELISA Instructions

DRG International EIA-4394 Cystatin C Human ELISA

Please use only the valid version of the Instructions for Use provided with the kit.

Introduced modifications

The following changes have been made in comparison to the previous version:

PREPARATION OF REAGENTS: Added: “Centrifuge liquid containing microtube vials before opening.”

INTENDED USE

The Cystatin C (human) ELISA is a sandwich enzyme immunoassay for the quantitative measurement of human cystatin C

Features

• The total assay time is less than 2 hours.
• The kit measures total cystatin C in serum, plasma (EDTA, citrate, heparin), urine and cerebrospinal fluid.
• Assay format is 96 wells.
• Quality Controls are human serum or human urine native protein based. No animal sera are used.
• Standard is purified native protein based.
• Components of the kit are provided ready to use or concentrated.

STORAGE, EXPIRATION

Store the complete kit at 2 °C – 8 °C. Under these conditions, the kit is stable until the expiration date (see label on the box).

For stability of opened reagents see Chapter 9.

INTRODUCTION

Cysteine proteinase inhibitors, cystatins superfamily, have been identified in animals, plants and protozoa. All cystatins inactivate lysosomal cysteine proteinases, e.g. cathepsin B, H, K, L and S as well as some structurally related plant proteinases, such as papain and actinidin. Human cystatin C is produced at a constant rate by all nucleated body cells and occurs in all body fluids abundantly. It is a non-glycosylated basic single-chain protein consisting of 120 amino acids with a molecular weight of 13.36 kDa and is characterized by two disulfide bonds in the carboxy-terminal region. The protein is encoded by the CS73 gene located on the short arm of chromosome 20.

Biological function of human cystatin C, and its role in various pathological states, has been the subject of numerous studies. Imbalance between cystatin C and cysteine proteinases is associated with diseases such as inflammation, renal failure, cancer, Alzheimer disease, multiple sclerosis and hereditary cystatin C amyloid angiopathy. Its increased level has been found in patients with autoimmune diseases, with colorectal tumors and metastases, patients with inflammation and in patients on dialysis. Serum cystatin C concentration correlates negatively with glomerular filtration rate (GFR) as well as or better than creatinine, therefore was recently proposed as a new, very sensitive, marker of changes in GFR.

On the other hand, low levels of cystatin C come along the breakdown of the elastic laminae and, subsequently, the atherosclerosis and abdominal aortic aneurysm, as indicate latest publications. Results make evident association of cystatin C levels with the incidence of myocardial infarction, coronary death and angina pectoris. Furthermore, cystatin C correlates with triglycerides, LDL-cholesterol, BMI and age of individuals. Thus, low concentration of cystatin C presents a risk factor for secondary cardiovascular events.

Areas of investigation:
Renal disease

TEST PRINCIPLE

In the Human Cystatin C ELISA, standards, quality controls and samples are incubated in microtitrate plate wells percolated with polyclonal anti-human cystatin C antibody.

After 30 minutes incubation and washing, polyclonal anti-human cystatin C antibody, conjugated with horseradish peroxidase (HRP) is added to the wells and incubated for 30 minutes with captured cystatin C. Following another washing step, the remaining HRP conjugate is allowed to react with the substrate solution (TMB). The reaction is stopped by addition of acidic solution and absorbance of the resulting yellow product is measured

The absorbance is proportional to the concentration of cystatin C.
A standard curve is constructed by plotting absorbance values against concentrations of cystatin C standards, and concentrations of unknown samples are determined using this standard curve.

PRECAUTIONS

• For professional use only.
• Wear gloves and laboratory coats when handling immunodiagnostic materials.
• Do not drink, eat or smoke in the areas where immunodiagnostic materials are being handled.
• This kit contains components of human origin. These materials were found non-reactive for HBsAg, HCV antibody and for HIV 1/2 antigen and antibody. However, these materials should be handled as potentially infectious, as no test can guarantee the complete absence of infectious agents.
• Avoid contact with the acidic Stop Solution and Substrate Solution, which contains hydrogen peroxide and tetramethylbenzidine (TMB). Wear gloves and eye and clothing protection when handling these reagents. Stop and/or Substrate Solutions may cause skin/eyes irritation. In case of contact with the Stop Solution and the Substrate Solution wash skin/eyes thoroughly with water and seek medical attention, when necessary.
• The materials must not be pipetted by mouth.

TECHNICAL HINTS

• Reagents with different lot numbers should not be mixed.
• Use thoroughly clean glassware.
• Use deionized (distilled) water, stored in clean containers.
• Avoid any contamination among samples and reagents. For this purpose, disposable tips should be used for each sample and reagent.
• Substrate Solution should remain colorless until added to the plate. Keep Substrate Solution protected from light.
• Stop Solution should remain colorless until added to the plate. The colour developed in the wells will turn from blue to yellow immediately after the addition of the Stop Solution. Wells that are green in colour indicate that the Stop Solution has not mixed thoroughly with the Substrate Solution.
• Dispose of consumable materials and unused contents in accordance with applicable national regulatory requirements.

REAGENT SUPPLIED

MATERIAL REQUIRED BUT NOT SUPPLIED

• Deionized (distilled) water
• Test tubes for diluting samples
• Glassware (graduated cylinder and bottle) for Wash Solution (Dilution Buffer)
• Precision pipettes to deliver 10-1000 µL with disposable tips
• Multichannel pipette to deliver 100 µL with disposable tips
• Absorbent material (e.g. paper towels) for blotting the microtitrate plate after washing
• Vortex mixer
• Orbital microplate shaker capable of approximately 300 rpm
• Microplate washer (optional). [Manual washing is possible but not preferable.]
• Microplate reader with 450 ± 10 nm filter, preferably with reference wavelength 630 nm (alternatively another one from the interval 550 – 650 nm)
• Software package facilitating data generation and analysis (optional)

PREPARATION OF REAGENTS

All reagents need to be brought to room temperature prior to use.
Centrifuge liquid containing microtube vials before opening.
Always prepare only the appropriate quantity of reagents for your test.
Do not use components after the expiration date marked on their label.

Assay reagents supplied ready to use:

Antibody Coated Microtiter Strips

Stability and storage:

Return the unused strips to the provided aluminium zip-sealed bag with desiccant and seal carefully. Remaining Microtiter Strips are stable 3 months stored at 2 °C – 8 °C and protected from the moisture.

Conjugate Diluent
Substrate Solution
Stop Solution

Stability and storage:
Opened reagents are stable 3 months when stored at 2 °C – 8 °C.

Assay reagents supplied concentrated:

Dilution Buffer Conc. (10x)

Dilute Dilution Buffer Concentrate (10x) ten-fold in 90 mL distilled water to prepare a 1x working solution, e.g. 10 mL of Dilution Buffer Concentrate (10x)

• 90 mL of distilled water for use of all 96-wells.
  It is recommended to dilute only such a volume of Dilution Buffer Concentrate (10x) to be used up in the one run of the test.

Stability and storage:

The diluted Dilution Buffer is stable 1 week when stored at 2 °C – 8 °C.
Opened Dilution Buffer Concentrate (10x) is stable 3 months when stored at 2 °C – 8 °C.

Set of Standards
Dilute each concentration of Standard 400x with the Dilution Buffer just prior to the assay in two steps as follows:

Dilution A (10x):
Add 10 µL of Standard into 90 µL of Dilution Buffer. Mix well (not to foam). Vortex is recommended.

Dilution B (40x):
Add 10 µL of Dilution A into 390 µL of Dilution Buffer to prepare final dilution (400x). Mix well (not to foam). Vortex isrecommended.

Stability and storage:

Opened Standards are stable 3 months when stored at 2 °C – 8 °C.

Do not store the diluted set of Standards.

Quality Controls High, Low

Refer to the Certificate of Analysis for current Quality Control concentration!!!

Dilute each Quality Control (QC) 400x with the Dilution Buffer just prior to the assay in two steps as follows:

Dilution A (10x):
Add 10 µL of QC into 90 µL of Dilution Buffer. Mix well (not to foam). Vortex is recommended.

Dilution B (40x):
Add 10 µL of Dilution A into 390 µL of Dilution Buffer to prepare final dilution (400x). Mix well (not to foam). Vortex is recommended.

Stability and storage:

Opened Quality Controls are stable 3 months when stored at 2 °C – 8 °C.
Do not store the diluted Quality Controls.

Note:
Concentration of analyte in Quality Controls need not be anyhow associated with normal and/or pathological concentrations in serum or another body fluid. Quality Controls serve just for control that the kit works in accordance with the IFU and CoA and that ELISA test was carried out properly.

It is recommended to supplement two or three negative sample controls of customer´s own (in addition to those provided with this kit). They can serve as evidence of the difference between positive and negative samples (see Figure 6 and Figure 7).

Conjugate Solution Conc. (50x)

Prepare the working Conjugate Solution by adding 1 part concentrated Conjugate Solution Concentrate (50x) with 49 parts Conjugate Diluent.

Example:
0.25 mL of Conjugate Solution Concentrate (50x) + 12.25 mL of Conjugate Diluent for use of all 96-wells.
Prepare only the volume needed for the test. Mix well (not to foam).

Stability and storage:
Opened Conjugate Solution Concentrate (50x) is stable 3 months when stored at 2 °C – 8 °C.
Do not store the diluted Conjugate Solution.

Wash Solution Conc. (10x)
Dilute Wash Solution Concentrate (10x) ten-fold in 900 mL of distilled water to prepare a 1x working solution, e.g. 100 mL of Wash Solution Concentrate (10x) + 900 mL of distilled water for use of all 96-wells.

Stability and storage:
The diluted Wash Solution is stable 1 month when stored at 2 °C – 8 °C.
Opened Wash Solution Concentrate (10x) is stable 3 months when stored at 2 °C – 8 °C.

PREPARATION OF SAMPLES

The kit measures cystatin C in serum, plasma (EDTA, citrate, heparin), urine and cerebrospinal fluid. Samples should be assayed immediately after collection or should be stored at -20 °C. Mix thoroughly thawed samples just prior to the assay and avoid repeated freeze/thaw cycles, which may cause erroneous results. Avoid using hemolyzed or lipemic samples.

Dilute samples (serum, plasma) 400x with the Dilution Buffer just prior to the assay in two steps as follows:

Dilution A (10x):
Add 10 µL of sample into 90 µL of Dilution Buffer. Mix well (not to foam). Vortex is recommended.

Dilution B (40x):
Add 10 µL of Dilution A into 390 µL of Dilution Buffer to prepare final dilution (400x). Mix well (not to foam). Vortex is recommended.

Dilute samples (CSF) 1600x with the Dilution Buffer just prior to the assay as follows:

Dilution A (40x):
Add 10 µL of sample into 390 µL of Dilution Buffer. Mix well (not to foam). Vortex is recommended.

Dilution B (40x):
Add 10 µL of Dilution A into 390 µL of Dilution Buffer to prepare final dilution (1600x). Mix well (not to foam). Vortex is recommended.

Stability and storage:

Samples should be stored at -20 °C, or preferably at -70 °C for long-term storage. Avoid repeated freeze/ thaw cycles.
Do not store the diluted samples.

For dilution of urine samples see Chapter 15.

See Chapter 13 for stability of serum and plasma samples when stored at 2 °C – 8 °C, effect of freezing/thawing and effect of sample matrix (serum/plasma) on the concentration of cystatin C.

Note: It is recommended to use a precision pipette and a careful technique to perform the dilution in order to get precise results.

ASSAY PROCEDURE

1. Pipet 100 µL of diluted Standards, Quality Controls, Dilution Buffer (=Blank) and samples, preferably in duplicates, into the appropriate wells. See Figure 1 for example of work sheet.
2. Incubate the plate at room temperature (ca. 25 °C) for 30 minutes, shaking at ca. 300 rpm on an orbital microplate shaker.
3. Wash the wells 3-times with Wash Solution (0.35 mL per well). After final wash, invert and tap the plate strongly against paper towel.
4. Add 100 µL of Conjugate Solution into each well.
5. Incubate the plate at room temperature (ca. 25 °C) for 30 minutes, shaking at ca. 300 rpm on an orbital microplate shaker.
6. Wash the wells 3-times with Wash Solution (0.35 mL per well). After final wash, invert and tap the plate strongly against paper towel.
7. Add 100 µL of Substrate Solution into each well. Avoid exposing the microtiter plate to direct sunlight. Covering the plate with e.g. aluminium foil is recommended.
8. Incubate the plate for 10 minutes at room temperature. The incubation time may be extended [up to 20 minutes] if the reaction temperature is below than 20 °C. Do not shake with the plate during the incubation.
9. Stop the colour development by adding 100 µL of Stop Solution.
10. Determine the absorbance of each well using a microplate reader set to 450 nm, preferably with the reference wavelength set to 630 nm (acceptable range: 550 – 650 nm). Subtract readings at 630 nm (550 – 650 nm) from the readings at 450 nm.
    The absorbance should be read within 5 minutes following step 9.

Note: If some samples and standards have absorbances above the upper limit of your microplate reader, perform a second reading at 405 nm. A new standard curve, constructed using the values measured at 405 nm, is used to determine cystatin C concentration of off-scale standards and samples. The readings at 405 nm should not replace the readings for samples that were “in range” at 450 nm.

Note 2: Manual washing: Aspirate wells and pipet 0.35 mL Wash Solution into each well. Aspirate wells and repeat twice. After final wash, invert and tap the plate strongly against paper towel. Make certain that Wash Solution has been removed entirely.

| strip 1+2| strip 3+4| strip 5+6| strip 7+8| strip 9+10| strip 11+12
---|---|---|---|---|---|---
A| Standard 10 000| Blank| Sample 8| Sample 16| Sample 24| Sample 32
B| Standard 4 000| Sample 1| Sample 9| Sample 17| Sample 25| Sample 33
C| Standard 2 000| Sample 2| Sample 10| Sample 18| Sample 26| Sample 34
D| Standard 1 000| Sample 3| Sample 11| Sample 19| Sample 27| Sample 35
E| Standard 400| Sample 4| Sample 12| Sample 20| Sample 28| Sample 36
F| Standard 200| Sample 5| Sample 13| Sample 21| Sample 29| Sample 37
G| QC High| Sample 6| Sample 14| Sample 22| Sample 30| Sample 38
H| QC Low| Sample 7| Sample 15| Sample 23| Sample 31| Sample 39

Figure 1: Example of a work sheet.

CALCULATIONS

Most microplate readers perform automatic calculations of analyte concentration. The standard curve is constructed by plotting the mean absorbance (Y) of Standards against the known concentration (X) of Standards in logarithmic scale, using the four-parameter algorithm. Results are reported as concentration of cystatin C ng/mL in samples. Alternatively, the logit log function can be used to linearize the standard curve i.e. logit of the mean absorbance (Y) is plotted against log of the known concentration (X) of Standards. Use values of undiluted standard range: 10 000, 4 000, 2 000, 1 000, 400, 200 ng/mL. Samples, Quality Controls and Standards are all diluted 400x prior to analysis, so there is no need to take this dilution factor into account.

Results are reported as total concentration of cystatin C (ng/mL) in serum/plasma samples.

For the determination of concentration in samples diluted differently, use dilution factor for dividing/multiplying results read off the standard curve.

PERFORMANCE CHARACTERISTICS

Typical analytical data of the Human Cystatin C ELISA are presented in this chapter.

Sensitivity

Limit of Detection (LOD) (defined as concentration of analyte giving absorbance higher than mean absorbance of blank plus three standard deviations of the absorbance of blank: Ablank + 3xSDblank) is calculated from the real cystatin C values in wells and is 0.25 ng/mL. Dilution Buffer is pipetted into blank wells.

Limit of assay

Results exceeding cystatin C level of 10 000 ng/mL should be repeated with more diluted samples. Dilution factor needs to be taken into consideration in calculating the cystatin C concentration.

Example:

Dilute samples 800x and dilution factor needs to be taken into consideration. The result (read off standard curve) is then multiplied by 2.

Conversely: If a sample is diluted only 50x instead of 400x, due to lower concentration of analyte, the result (read off the standard curve) is divided by dilution factor 8, in this case.

Standard curve is plotted without changes, in both above mentioned cases, i.e. in undiluted concentrations: 10 000, 4 000, 2 000, 1 000, 400 and 200 ng/mL.

Note: cystatin C standard range 10 000-200 ng/mL, after 400x dilution, results in the actual concentration range 25 – 0.25 ng/mL, which represents concentration 2.5 – 0.025 ng/well.

Thus, the assay system is capable of measuring these concentrations 25 – 0.25 ng/mL in 400x diluted samples, which can help to decide what dilution choose for samples other than sera.

Specificity

The antibodies used in this ELISA are specific for human cystatin C.
Determination of cystatin C does not interfere with hemoglobin (1.0 mg/mL), bilirubin (170 umol/L) and triglycerides (5.0 mmol/L).

Sera of several mammalian species were measured in the assay. See results below. For details please contact DRG

Mammalian serum sample

| Observed Cross reactivity
---|---
Bovine|

no

Cat

| no
Dog|

no

Goat

| no
Hamster|

no

Horse

| no
Monkey|

yes

Mouse

| no
Pig|

no

Rabbit

| no
Rat|

no

Sheep

|

no

Precision

Intra-assay (Within-Run) (n=8)

Sample

| Mean (ng/mL)| SD (ng/mL)| CV (%)
---|---|---|---

1

| 1510| 50|

3.3

2| 1787| 63|

3.5

Inter-assay (Run-to-Run) (n=6)

Sample| Observed (ng/mL)| Expected (ng/mL)| Recovery O/E (%)
---|---|---|---
1| 771 1146 1435 2702| – 1171 1571 2771| – 98 91 98
2| 978 1338 1566 2904| – 1378 1778 2978| – 97 88 98

Spiking Recovery

Serum samples were spiked with different amounts of human cystatin C, diluted with Dilution Buffer 400x, and assayed.

Sample| Dilution| Observed (ng/mL)| Expected (ng/mL)| Recovery O/E (%)
---|---|---|---|---
1| – 2x 4x 8x| 2 773 1 340 662 353| – 1 387 693 347| – 97 95 102
2| – 2x 4x 8x| 2 682 1 289 656 331| – 1 341 671 335| – 96 98 99

Effect of sample matrix

EDTA, citrate and heparin plasmas were compared to respective serum samples from the same 10 individuals. Results are shown below:

Stability of samples stored at 2 °C – 8 °C

Samples should be stored at -80 °C. However, no decline in concentration of cystatin C was observed in serum and plasma samples after 7 days when stored at 2 °C – 8 °C. To avoid microbial contamination, samples were treated with ε-aminocaproic acid and sodium azide, resulting in the final concentration of 0.03% and 0.1%, respectively.

Sample
Number:| Incubation:
Temperature, Period| Serum (ng/mL)| Plasma (ng/mL)
---|---|---|---
EDTA| Citrate| Heparin
1| -80 °C| 1 023| 700| 620| 639
2 °C – 8 °C, 1 day| 921| 773| 592| 648
2 °C – 8 °C, 7 day| 1 171| 762| 615| 647
2| -80 °C| 707| 719| 571| 621
2 °C – 8 °C, 1 day| 725| 737| 568| 606
2 °C – 8 °C, 7 day| 618| 634| 482| 563
3| -80 °C| 625| 660| 483| 603
2 °C – 8 °C, 1 day| 639| 637| 499| 620
2 °C – 8 °C, 7 day| 636| 651| 552| 603
4| -80 °C| 530| 549| 466| 579
2 °C – 8 °C, 1 day| 561| 568| 518| 529
2 °C – 8 °C, 7 day| 502| 610| 486| 512

Effect of Freezing/Thawing
No decline was observed in concentration of human cystatin C in serum and plasma samples after repeated (5x) freeze/thaw cycles. However it is recommended to avoid unnecessary repeated freezing/thawing of the samples.

Sample Number:| Number of f/t Cycles| Serum (ng/mL)| Plasma (ng/mL)
---|---|---|---
EDTA| Citrate| Heparin
1| 1x| 785| 774| 544| 867
3x| 855| 765| 602| 783
5x| 789| 755| 615| 746
2| 1x| 599| 721| 613| 719
3x| 549| 715| 531| 734
5x| 632| 676| 632| 740
3| 1x| 618| 473| 310| 624
3x| 523| 554| 260| 545
5x| 593| 553| 855| 629
4| 1x| 387| 518| 394| 454
3x| 370| 411| 354| 442
5x| 461| 465| 349| 497

DEFINITION OF THE STANDARD

The Standard used in this kit is purified native protein based.
The standards used in the kit were calibrated against the European Reference Material ERM-DA471/IFCC.

URINE CYSTATIN C DETERMINATION

For the determination of cystatin C in urine use the serum/plasma protocol only with the following modifications:

Sample collection and storage

It is recommended to freeze down untreated urine although no significant decline was observed in concentration of human cystatin C in samples stored at 4 °C for 14 days.

Sample preparation

Dilute urine samples 20x with Dilution Buffer just prior to use in the assay, e.g.: 20 µL of sample + 380 µL of Dilution Buffer.
Stability and storage:
Untreated urine samples are stable for 3 months if stored at -20 °C/ -70 °C. Do not store the diluted samples.

Calculations of results

Standard curve is plotted using values of undiluted Standards: 10 000, 4 000, 2 000, 1 000, 400 and 200 ng/mL.
As urine samples are diluted only 20x whereas Standards are diluted 400x, the result (read off the Standard curve) has to be divided by dilution factor 20 in order to obtain the real concentration in the original (undiluted) sample.

Effect of freezing/thawing on the concentration of cystatin C in urine

Cystatin C levels were determined in the morning urine from fifteen individuals who were examined because of a suspicion of renal dysfunction. All of them had urine protein < 0.3 g/day and a normal count of leukocytes in urine. Assay results are shown below:

Sample No.

| Cystatin C (ng/mL)
---|---

1x F/T

|

5x F/T

1| 31|

33

2

| 62| 66
3| 30|

22

4

| 11| 13
5| 24|

24

6

| 22| 24
7| 48|

42

8

| 32| 30
9| 27|

32

10

| 101| 95
11| 39|

41

12

| 51| 63
13| 10|

8

14

| 84| 86
15| 47|

43

PRELIMINARY POPULATION AND CLINICAL DATA

The following results were obtained when serum samples from 155 unselected donors (89 men + 66 women) 21 – 65 years old were assayed with the Cystatin C (human) ELISA in our laboratory.

Sex

| Age (years)| n| Cystatin C (ng/ml)
---|---|---|---
Mean| Median| SD| Min|

Max

Men

| 20-29| 17| 1191.2| 952.9| 548.3| 477.4| 2225.0
30-39| 25| 1204.0| 1211.4| 434.9| 275.2|

2038.5

40-49

| 31| 1093.6| 1018.4| 397.6| 414.0| 2353.4
50-65| 16| 1208.0| 960.2| 639.0| 529.3|

3175.3

Women

| 20-29| 12| 930.2| 1010.3| 279.9| 442.1| 1263.7
30-39| 26| 1082.2| 1040.0| 334.2| 555.0|

1687.5

40-49

| 20| 878.4| 808.9| 321.7| 501.0| 1794.4
50-61| 8| 984.9| 919.7| 320.3| 693.1|

1687.5

Sera from eight patients on long-term dialysis were measured and their cystatin C levels compared to control sera from ten normal, apparently healthy individuals:

Sample No.

| Cystatin C (ng/mL)| CV (%)
---|---|---

1

| 8335|

6

2| 8014|

8

3

| 6822| 1
4| 9464|

8

5

| 7844| 8
6| 3366|

4

7

| 5955| 1
8| 3583|

14

Sample No.

| Cystatin C (ng/mL)|

CV (%)

---|---|---

pooled serum

| 1032| 11
1| 885|

9

2

| 979| 4
3| 703|

8

4

| 1178| 6
5| 943|

8

6

| 751| 9
7| 850|

5

8

| 1532| 6
9| 1328|

2

Reference range

The data quoted in these instructions should be used for guidance only. It is recommended that each laboratory include its own panel of control sample in the assay. Each laboratory should establish its own normal and pathological references ranges for cystatin C levels with the assay.

ETHOD COMPARISON

The Human cystatin C ELISA was compared to the other commercial immunoturbidimetric assay, by measuring 38 serum samples. The following correlation graph was obtained.

TROUBLESHOOTING AND FAQS

Weak signal in all wells
Possible explanations:

• Omission of a reagent or a step
• Improper preparation or storage of a reagent
• Assay performed before reagents were allowed to come to room temperature
• Improper wavelength when reading absorbance

High signal and background in all wells
Possible explanations:

• Improper or inadequate washing
• Overdeveloping; incubation time with Substrate Solution should be decreased before addition of Stop Solution
• Incubation temperature over 30°C

High coefficient of variation (CV)
Possible explanation:

• Improper or inadequate washing
• Improper mixing Standards, Quality Controls or samples

SYMBOLS USED

Symbol|
---|---
| European Conformity
| Consult instructions for use *
| In vitro diagnostic medical device *
***| Catalogue number
| Batch code *
***| Contains sufficient for tests

| Temperature limit *

| Use-by date *
*| Manufacturer
***| Caution
|
RUO**| For research use only
Distributed by| Distributed by
Content| Content
Volume/No.| Volume / No.

CUSTOMERS SUPPORT

DRG Instruments GmbH,
Frauenbergstraße 18, 35039 Marburg
Phone: +49 (0)6421-1700 0, Fax: +49 (0)6421-1700 50
Website: www.drg-diagnostics.de
E-mail: drg@drg-diagnostics.de

Distributed by:

DRG International, Inc., USA
841 Mountain Ave., Springfield, NJ 07081
Phone: 973-564-7555, Fax: 973-564-7556
Website: www.drg-international.com
E-mail: corp@drg-international.com

References

• Analyticon® Biotechnologies GmbH
• It's Uptime | International® Trucks
• DRG Diagnostics GmbH | Home
• Medical Supplies & Diagnostic Products | DRG International, Inc.

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