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Kardioline HCG Urine Pregnancy Test (Cassette)
For Self-Testing
INTERPRETATION OF THE SYMBOLS ON THE PACKAGE
REAGENTS
Test device comprised colloidal gold coated with anti β-HCG monoclonal antibody, NC membrane coated with anti α-HCG monoclonal antibody and rabbit anti mouse IgG Symbol for “Attention, see instructions for use” MATERIALS PROVIDED
Each pouch contains:
1. Kardioline HCG Urine Pregnancy Test Cassette2. One sample dropper Symbol for “Authorised representative in the European community” Symbol for “Contains sufficient for <1> tests” Each box contains:
Symbol for “In vitro diagnostic medical device” Symbol for “Consult instructions for use” Other equipment or reagents needed but not provided.
WARNING | FOR IN VITRO DIAGNOSITC USE ONLY
1. Timer2. Quality control material - Commercial control material or fresh samples from known 1. Read directions for use carefully before performing this test. Pay attention to the position pregnant and non-pregnant patients may be used with each lot as controls to verify the 2. Do not use beyond the labeled expiration date.
performance of the test. We recommend using control materials with HCG concentrations 3. Do not reuse the test devices. Discard it in the dustbin after single use.
known to be near (above and below) the clinical cutoff.
4. Do not use if pouch is damaged or opened.
5. Do not touch the membrane on the strip.
STORAGE AND STABILITY
6. Once open the pouch, the test device should be used immediately. Prolonged exposure The test kit can be stored at normal temperature (4 °C to 30 °C, or 39ºF to 86ºF) in the sealed to ambient humidity will cause product deterioration.
pouch to the date of expiration. The test kits should be kept away from direct sunlight, mois- 7. Treat urine samples and used devices as if they are potentially infectious. Avoid contact 8. Ensure there is urine container before test.
ASSAY PROCEDURE
INTENDED USE
1. DETERMINATION OF TEST DATE - The test could be used from the first date of missed
Kardioline HCG Urine Pregnancy Test is a self-performing immunoassay designed for menstruation. In most cases the test is accurate at this date. However, because of variation the qualitative determination of human chorionic gonadotropin (HCG) in urine for early in HCG concentration among women, or potential miscalculation of the last period, if there detection of pregnancy by visual. Kardioline HCG Urine Pregnancy Test is designed for both is a negative result, and pregnancy is still suspected, you should retest after a few days. SUMMARY AND EXPLANATION
2. SPECIMEN COLLECTION AND HANDLING - First morning urine specimen is preferred
due to its high concentration of HCG. However, urine specimens collected at any time of the
Human Chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by the developing day may be used. If specimens cannot be assayed immediately, they can be stored at 2-8ºC placenta shortly after fertilization. During normal pregnancy, HCG can be detected in urine as early as 7 days following conception, doubling every 1.3 to 2 days. At the time of the last for up to 72 hours prior to testing. Urine specimens exhibiting visible precipitates should be missed menstrual period, urine HCG levels are about 100mlU/ml with peak levels of 100,000 settled to obtain a clear specimen for testing.
to 200,000mlU/ml seen at the end of the first trimester. The presence of HCG soon after conception and its subsequent increase in concentration during early gestational growth 3. TEST PROCEDURE
make it an ideal marker for the early detection of pregnancy.
1. Bring the test pouch and urine to room temperature. To begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch and use it as soon as PRINCIPLE
The Kardioline HCG Urine Pregnancy Test is a rapid one-step test, based on an 2. Using the sample dropper, draw about 3 drops immunochromatographic technology. A membrane with an absorbent pad overlaps a strip of (approximately 120-150 μl) urine sample from the fiber glass paper that is impregnated with a lyophilized colloidal conjugate of gold particles specimen cup into the pipette, and dispense it into the and monoclonal solid phase antibodies to HCG. Another absorbent pad at the end of the assay sample well on the cassette. (See the picture).
absorbs excess sample fluid. The urine sample is introduced into the device, and proceeds 3. Wait for colored bands to appear. Depending on the through the absorbent pad, then laterally onto a chromatographic membrane. As it contacts concentration of HCG in the test specimen, Positive the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the HCG results may be observed in as short as 40 seconds. antigen will bind to the antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti-HCG monoclonal antibody affixed on the test zone (“T”) will bind the HCG- However, to confirmNegative results, the complete gold conjugate complex, forming a pink line (“T”). All samples will cause a pink colored line in reaction time (5 minutes) is required. So read the result the control zone (“C”). This line is formed by the binding of the polyclonal antibodies (Anti- mouse IgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of 4. Do not read results after 30 minutes.
this line indicates sample amount is appropriate and the test has been carried out correctly. In less than 5 minutes, levels of HCG as low as 25mlU/ml can be detected.
Shanghai International Holding Corp. GmbH (Europe)
Blue Cross Bio-Medical (Beijing) Co., Ltd
Kardioline Swiss GmbH | Oberbüntelistrasse 14 | CH-9443 Widnau
Eiffestrasse 80 | 20537 Hamburg | Germany Beiqijia Industry Zone, Changping District, Beijing, P.R.C 102209 Switzerland | www.kardioline.com
Kardioline HCG Urine Pregnancy Test (Cassette)
For Self-Testing
4. Non-cross reacting compounds
INTERPRETATION OF RESULT
Acetaminophen
Positive:
Two distinct color bands appear - one on the control and one on the test region. This indicates that pregnancy has been detected. The color intensity of the test bands may Acetosal
Salicylic Acid
Negative: Only one color band appears on the control line, and no band appears on the test
region. This means there is no pregnancy detected.
Ascorbic Acid
Invalid: There are no visible bands at all, or if one red band appears only on the test region.
Caffeine
If this happens, repeat a new test. If test still fails, please contact the distributor with the Gentisic
Thiophene
Ampicillin
QUALITY CONTROL
Tetracycline
Hemoglobin
Positive
Negative
Control Line
Result Window
Bilirubin
Test Line
Pregnanedione
Sample Well
5. Repeatability and Reproducibility - Three lots of Kardioline HCG Urine Pregnancy
Test were used and 10 strips of each lot were tested in HCG standard solution with different
concentrations prepared at 0 mIU/ml, 25 mIU/ml and 100 mIU/ml.
Testing of quality control material to verify the performance of the test is recommended for each new lot of test. In addition, users should follow their state and local regulations and guidelines regarding GLP requirements. In addition, a built in procedural control is being concentration
Variability
used designated as control region (C) on the test device to indicate that sufficient sample PERFORMANCE CHARACTERISTICS
P: positive | N: negative | All samples were positive at and beyond the cut-off level. No
1. Sensitivity - Kardioline HCG Urine Pregnancy Test will display positive results with
specimens containing HCG at the level close to or greater than 25mlU/ml.
LIMITATION OF THE PROCEDURE
2. Specificity - The following compounds exhibited no interference when dissolved
in urine, which had HCG levels of 0 and 25mlU/ml.
1. Alcohol may interfere with test result. It is not recommended using the test after drinking.
2. Occasionally specimens containing less than 25mlU/ml for urine also yield positive results. hFSH 1000 mIU/ml (WHO 1st IS)
3. A very early pregnancy containing an extremely low concentration of hCG can give a ne- hLH 500mIU/ml (WHO 1st IRP)
gative result. In this case, another specimen should be obtained at least 48 hours later hTSH 1000μIU/ml (WHO 2nd IRP)
3. ACCURACY - Comparison studies on the Kardioline HCG Urine Pregnancy Test with a
4. HCG levels may remain detectable for several weeks after normal delivery, delivery by legally marketed device were performed in various clinical reference laboratory. Positive caesarean section, spontaneous abortion or therapeutic abortion.
and negative results were compared and the correlation was >99.9%.
5. In cases where very high levels of HCG are present (>500,000 mlU/ml) a false negative result can occur due to a “Prozone” effect. If pregnancy is still suspected, simply dilute Clinical Accuracy of Kardioline HCG Urine Pregnancy Test specimen 1:1 with deionized water and retest.
Reference method
Reference method
6. If a urine sample is too dilute (i.e.: low specific gravity) it may not contain a representa- (Positive)
(Negative)
tive level of HCG. If pregnancy is still suspected, a first morning urine sample should be 7. As is true with any diagnostic procedure, the user should evaluate data obtained by the use of this kit in light of other clinical information and consult to the physicians for the final diagnosis of pregnancy before make any decision of medical relevance.
REFERENCE
Diagnostic Sensitivity (Positive agreement) =411/ (411+0) =100% Diagnostic Specificity (Negative agreement) =309/ (309+0) = 100% 1. Chard T. Pregnancy tests: a review. Hum Reprod. 1992 May; 7(5):701-10. Review.
2. American Pregnancy Association. Human Chorionic Gonadotropin (HCG): The Pregnancy Hormone. http://www.americanpregnancy.org/duringpregnancy/hcglevels.html 3. Womens health Research. Dept. of OB/GNY, University of New Mexico. HCG Reference Service. http://www.hcglab.com/hCG%20levels.htm4. Chayen J, Daly JR, Loveridge N. The cytochemical bioassay of hormones. Recent Prog. Horm. Res. 1976; 32:33-72.
Comparison studies on the Karidoline HCG Urine Pregnancy Test with a legally marketed 5. Henry JB. Clinical Diagnosis and Management by Laboratory Methods, 18th edition, 1991, WB Saunders and Co.
device were performed in various clinical reference laboratory. Positive and negative results 6. Wide L, Gemzell CA. An immunological pregnancy test. Acta Endocrinology 1960; 35:261.
7. Cart, K.J. J. Clin. Endocrinol. Metab., 1975,40 :537 were compared and the correlation was >99.9%.
8. Braustein, G. D. Am J. Obstet. Gynecol., 1976,126:6789. Batzer, F.R. Fertility & Sterility, 1980, 34:1.
10. Engvall, E. Method in Enzymology, 1980, 70:419.

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