Keul-o-test

Semi Quantitative CRP Test Cassette

For Serum, Plasma or Whole Blood Specimens with a 60mg/L Reference Marker

KGST190
DIMDI Reg.-Nr.: DE/CA22/1116-111-IVD

Explanation of the Test
A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in whole blood. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.  For professional use only.
The Semi Quantitative CRP test is a rapid test used to detect CRP in whole blood.  The sensitivity of the test is 10 mg/L CRP with a 60mg/L reference marker.

The CRP test kit contains the following items to perform the test:

• CRP Test Cassette
• 10µl Micropipette (for whole-blood collection)
• Buffer Solution
• Mixing Tube
• Sample Dropper
• Instructions.

Precautions
The CRP test kit should be stored at room temperature or 4-30^oC (40-86^oF).  If test kit is refrigerated, it should be brought to room temperature before use. The test device is sensitive to humidity as well as to heat.  Perform the test immediately after removing the test device from the foil pouch.  Do not use it beyond the expiration date.

Procedure of the Test

1. Open the buffer bottle and hold it upside down. Make sure holding the bottle vertically (Note: drops may contain air-bubbles if not holding the buffer bottle vertically), slowly add 13 to 14 hanging drops to the mixing tube.
2. Collect 10µl of whole-blood (up to the black line on the 10µl Micropipette) or 3.5µl (collection pipette not provided) of serum/plasma into the mixing tube already containing the buffer, mix well.
3. Remove the sample dropper and test cassette from the foil pouch. Place the test cassette on a flat, dry surface. Obtain specimen from the mixing tube using the sample dropper, and holding the sample dropper above the test cassette and add 7 to 8 drops into the Sample Well.
4. As the test begins to work, you will see purple color dyes move across the Result Window in the center of the test cassette.
5. Interpret test results at 10 minutes. Do not interpret test results after 12 minutes.

Caution: The above interpretation time is based on reading the test results at room temperature of 15 to 30 degrees C.  If your room temperature is significantly lower than 15 degrees C, then the interpretation time should be properly increased.

Interpretation of the Test:

1. A color band will appear at the left section of the Result Window to show that the test is working properly. This band is the Control Band ("C" band).
2. The middle section of the Result Window indicates the Reference Band ("R" band).
3. The right section of the Result Window indicates the Test Band ("T" band).

CRP concentration of less than 10mg/L: there is no visible test line (T).

CRP concentration of 10mg/L or less than 60mg/L: The intensity of the test line (T) is weaker than reference line (R) indicating that CRP level is 10mg/L to less than 60mg/L.

CRP concentration of 60mg/L: The intensity of the test line (T) is similar to the reference line (R) indicating that CRP level is 60mg/L.

CRP concentration higher than 60mg/L: The intensity of the test line (T) is darker than the reference line (R) indicating that CRP level is higher than 60mg/L.

Note: Generally, the higher the CRP level in the specimen, the stronger the "T" band color will be.  Specimen with very high CRP level specimens (>1000mg/L) can cause reduced "T" line color intensity (Prozone Effect).

Invalid: If after performing the test, no color band for the reference band or the control band is visible within the Result Window, the result is considered invalid. Some causes of invalid results are not following the directions correctly, such as insufficient amount of sample or buffer added or the test may have deteriorated beyond the expiration date.

Note: A positive result will not change once it has been established at 10 minutes.  However, in order to prevent any incorrect results, the test result should not be interpreted after 12 minutes.  Interpreting test results after 12 minutes, the sensitivity of the test will be higher than 10mg/ml. Some specimens with a high rheumatoid factor concentration may yield a nonspecific positive result 

Limitations of the Test
Although the CRP Test is very accurate in detecting CRP, a low incidence of false results can occur.   Other clinically available tests are required if questionable results are obtained.
As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

Warnings

1. The same lancet needle (not provided with the test) should be used for one person only and should not be shared with another person, because the used needle is a biohazard.
2. Decontaminate and dispose of all specimens, reaction kits, lancet needles and potentially contaminated materials, as if they were infectious wastes, in a biohazard container.
3. Do not use the kit after the expiration date.
4. For in vitro diagnostic use only.

Interference Study
The following substances at the specified concentrations have not shown to interfere with the CRP test. Acetamiophen, 20 mg/dl; Acetyl salicylic Acid, 20 mg/dl; Ascorbic Acid, 20 mg/dl; Atropine, 20 mg/dl; Bilirubin, 60 mg/dl; Caffeine, 20 mg/dl; Creatinine, 20 mg/dl; Gentesic Acid, 20 mg/dl; Glucose, 2000 mg/dl; Hemoglobin, 500 mg/dl; Ketones, 40 mg/dl; Mestranol, 3 mg/dl; Nitrite, 20 mg/dl; Penicillin, 40,000 U/dl; Sodium Heparin, 3 mg/dl; Lithium Heparin, 3 mg/dl.

References:

1. Caswell M. Effect of patient age on tests of the acute-phase response. Arch Pathol Lab Med 1993;117:906-909.
2. Anderson R , Hugander A , Ghazi S , Ravan H , Offenbartl S, Nystron P et al. Diagnostic value of disease history, clinical presentation and inflammatory parameters of appendicitis. World J Surg 1999;23(2):133-40.

Manufacturer:

Von-Langen-Weg 10 D-48565 Steinfurt Tel.: 02551/4090  Fax.: 02551/1298 Web: www.biogentechnologies.com