Keul-o-test

PSA K

KGST183

DIMDI Reg.-Nr.: DE/CA22/1116-110-IVD

PSA Test for serum, plasma or whole blood specimen

Please read the instruction carefully before use!

INTENDED USE
Keul-o-test PSA K is an one step in vitro diagnostic test based on immunochromatographic assay. It is designed for detectection of human PSA in serum, plasma or whole blood specimen.

SUMMARY AND EXPLANATION
Prostate Specific Antigen(PSA) is an intracellular glycoprotein (34KDa) synthesized only by the prostate gland. PSA, a normal constituent of prostate tissue, is also present in benign hyperplastic and malignant prostatic tissue, in metastatic prostatic carcinoma, and in prostatic fluid and seminal plasma. However, it is not detected in cancers of lung, colon, breast, rectum, pancreas, stomach or thyroid.
The amount of PSA in the blood normally increases as a men's prostate enlarges with age. However, normal total PSA concentration of men, age 40 to 50, is less than 2.5 ng/ml. The concentration of PSA is elevated in blood of prostate cancer patients. The predictive value of PSA test is superior to that of either rectal examination or ultrasound alone. Since elevated levels of PSA are also seen in BPH(Benign Prostatic Hyperplasia) and other inflammation of urogenital tissues, measurement of blood PSA concentration is not recommended as a sole test procedure for diagnosis of cancer. But the combination of PSA test with ultrasonography provides a better method of detecting prostate cancer than rectal examination or ultrasonography alone.
The PSA test is effective in screening men for prostate cancer or monitoring its development and the response to treatment.    

PRINCIPLE OF THE TEST
Keul-o-test PSA K is an immunochromatographic assay. When sample is added to sample pad, it moves through the conjugate pad and mobilizes gold anti-PSA conjugate that is coated on the conjugate pad. The mixture moves along to the membrane by capillary action and reacts with anti-PSA antibody that is coated on the test region. If PSA is present in the sample at levels of 4.0ng/mL or greater, a color line is appeared in the test region. If PSA is present at a lower level, or not present in the sample, the test region will remain colorless. The sample continues to move to the control region and forms a colored line, indicating the test is working and its result is valid.

CONTENTS

• Test devices
• Droppers
• Instruction manual

CONPOSITION

STORAGE AND SHELF-LIFE

1. Store the test device packaged in a sealed foil pouch at 1 to 30^oC(34-86℉). Do not freeze.
2. Shelf-life : 18 months from manufacturing date.

PRECAUTIONS

1. For in vitro diagnostic use only.
2. Do not use the test device after expiry date.
3. Handle all specimens as potentially infectious.

SPECIMEN COLLECTION AND PREPARATION

1. The serum, plasma or whole blood may be used as samples and should be collected under standard laboratory conditions.
2. Whole blood or plasma collection :
   Collect blood in a tube containing anticoagulant such as heparin or EDTA and centrifuge the blood to get plasma specimen.
3. Serum collection :
   Collect blood in a tube without anticoagulant and allow clotting.
4. It is recommended that fresh samples be used as soon as possible, whole blood sample should be tested within 3 hours of collection. If specimens must be stored, the red blood cells should be removed. Plasma or serum samples may be refrigerated for 24 hours at 2-8℃. If plasma or serum samples must be stored for more than 24 hours, they should be frozen at -20℃ or below.
5. Heat inactivation of specimens, which may cause hemolysis and protein denaturation, should be avoided.

TEST PROCEDURE

1. Bring all materials and specimens to room temperature, and then open the foil pouch and place the device on a clean, dry and level surface.
   Note : Once the foil pouch is opened, the device should be used as soon as possible.
2. Write the specimen ID on the test device.
3. Use disposable pipette to transfer 100µl (about 3 hanging drops) of sample into the sample well.
   
   
   
   Note : Use a fresh pipette or tip for each samples in order to prevent cross-contamination.
4. Wait for 10 minutes and then read the results. Do not interpret the test results after 15 minutes.

INTERPRETATION OF RESULTS

1. Negative
If the test region(T) has no color line and the control region(C) displays a colored line, the result is negative.

2. Positive
If the test region(T) has a colored line and the control region(C) displays a colored line, the test result is positive. The test result can be read as soon as a distinct colored line appears in test region.

3. Invalid
If there is no red line in control region (C), the result is invalid. This is due to deterioration of the test device or improper test procedure. Repeat the test with a new test device.

QUALITY CONTROL
The control line is an internal control of the test reagents and procedure. It will appear if the test has been performed correctly and the reagents are reactive.
The 1^st international standard (NIBSC code 96/670) may be used as a reference standard.

LIMITATIONS OF THE TEST

1. For samples that test result is positive by Keul-o-test PSA K, more specific confirmatory testing should be done.
2. A clinical evaluation of the patient's situation and history should also be made before a final diagnosis is established.
3. The use of a rapid test alone is not sufficient to diagnosis prostate cancer even if antigen present. Also, a negative result at any time does not preclude the possibility of prostatic cancer.

EXPECTED VALUES
Keul-o-test PSA K is designed to yield a positive result for PSA concentrations at 4.0ng/mL or greater.

PERFORMANCE CHARACTERISTICS

1. Analytical Sensitivity
Keul-o-test PSA K can detect PSA with concentration of 4.0ng/mL or greater.

2. Clinical Accuracy
A clinical evaluation was conducted using a total 1.224 clinical specimens.  The Keul-o-test PSA K was tested on whole blood, plasma and serum specimen matrices.  No. discordant result was obtained from all specimen matrices.  The serum / plasma specimens from study subjects were also tested using a licensed Enyme Immunoassay (CanAg EIA test and ADVIA Centaur CP).

1) Serum test

Relative Sensitivity : > 99%(58/58)
Relative Specificity : 97.2%(105/108)
Overall Accuracy : 98.2%(163/166)

2) Plasma test

Relative Sensitivity : > 99%(23/23)
Relative Specificity : 95.1%(481/506)
Overall Accuracy : 95.3% (504/529)

3) Whole Blood test

Relative Sensitivity : > 99%(23/23)
Relative Specificity : 95.8%(485/506)
Overall Accuracy : 96.0%(508/529)

INTERFERING SUBSTANCES

The following substances do not interfere with Keul-o-test PSA-Test qualitative test result.

REFERENCES

1. Reiter RE et al., Prostate stem cell antigen : A cell surface marker overexpressed in prostate cancer. Proc Natl Acad Sci U S A. 1998, 95(4):1735~1740.
2. Haut MJ et al., Progressing prostate carcinoma. The oncologist. 2001, 6(2):183~196.
3. Woolf SH et al., Screening for prostate cancer with prostate-specific antigen. An examination of the evidence. N Engl J Med. 1995, 333(21):1401~1405.

CE₀₁₂₃  : This product fulfills the requirements for Directive 98/79/EC on in vitro diagnostic medical devices'

Manufacturer:

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

akt. 02.02.2010