hCG Card Pregnancy Test
(human chorionic gonadotropin)
RAPU01C040
DIAsource ImmunoAssays S.A. - Rue de l'Industrie, 8 - B-1400 Nivelles - Belgium
: 101118/1
en
FOR PROFESSIONAL USE ONLY
FOR IN-VITRO DIAGNOSTIC USE ONLY
A rapid, one step test for the qualitative detection of human chorionic
gonadotropin (hCG) in urine
INTENDED USE
The hCG Card Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of
human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
SUMMARY
Human chorionic gonadotropin is a glycoprotein hormone produced by the developing placenta shortly
after fertilization. In normal pregnancy, hCG can be detected in both urine and serum as early as 7 to 10
days after conception.1,2,3,4 hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by
the first missed menstrual period,2,3,4 and peaking in the 100,000-200,000 mIU/mL range about 10-12
weeks into pregnancy. The appearance of hCG in both the urine and serum soon after conception, and its
subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the
early detection of pregnancy.
The hCG Card Pregnancy Test is a rapid test that qualitatively detects the presences of hCG in urine
specimen at the sensitivity of 25 mIU/mL. The test utilizes a combination of monoclonal and polyclonal
antibodies to selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, the
hCG Card Pregnancy Test shows no cross-reactivity interference from the structurally related
glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
PRINCIPLE
The hCG Card Pregnancy Test is a rapid chromatographic immunoassay for the qualitative
detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. The
test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively
detect elevated levels of hCG. The assay is conducted by adding a urine specimen to the specimen
well of the test device and observing the formation of colored lines. The specimen migrates via
capillary action along the membrane to react with the colored conjugate.
Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line
at the test line region of the membrane. Absence of this colored line suggests a negative result. To
serve as a procedural control, a colored line will always appear in the control line region indicating that
proper volume of specimen has been added and membrane wicking has occurred.
REAGENTS
The test card contains anti-hCG particles and anti-hCG coated on the membrane.
PRECAUTIONS
• For professional in vitro diagnostic use only. Do not use after the expiration date.
• The test device should remain in the sealed pouch until use.
• All specimens should be considered potentially hazardous and handled in the same manner as an
infectious agent.
• The test device should be discarded in a proper biohazard container after testing.
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (2-30°C). The test card is stable through the
expiration date printed on the sealed pouch. The test card must remain in the sealed pouch until use. DO
NOT FREEZE. Do not use beyond the expiration date.
Catalogue Nr : RAPU01C040 P.I. Number : 1701256 Revision Nr : 101118/1
SPECIMEN COLLECTION AND PREPARATION
URINE ASSAY
A urine specimen must be collected in a clean and dry container. A first morning urine specimen is
preferred since it generally contains the highest concentration of hCG; however, urine specimens
collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be
centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
SPECIMEN STORAGE
Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage,
specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed
before testing.
MATERIALS
Materials provided
10 CARD 10 Testing devices in protective pouch with a desiccant.
10 PIPETTE 10 Disposable pipettes for single use only
Materials required but not provided
• Specimen collection container
• Timer
DIRECTION FOR USE
1. Allow the test device, urine specimen and/or controls to equilibrate to room temperature (15-30°C)
prior to testing.
2. Bring the pouch to room temperature before opening it. Remove the test device from the sealed
pouch and use it as soon as possible.
3. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full
drops of urine (approx. 180 µl) to the specimen well (S) of the test device, and then start the timer.
Avoid trapping air bubbles in the specimen well (S). See the illustration below.
4. The result should be interpretated between 3-5 minutes.
Please confirm negative results at 10 minutes.
Do not interpretate result exceeding 10 minutes.
Catalogue Nr : RAPU01C040 P.I. Number : 1701256 Revision Nr : 101118/1
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two distinct red lines appear. One line should be in the control region (C) and another line
should be in the test region (T).
*NOTE: The intensity of the red color in the test line region (T) will vary depending on the
concentration of hCG present in the specimen. Therefore, any shade of red in the test region (T) should
be considered positive.
NEGATIVE: One red line appears in the control region (C). No apparent red or pink line appears in
the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural
techniques are the most likely reasons for control line failure. Review the procedure and repeat the
test with a new test device. If the problem persists, discontinue using the test kit immediately and
contact your local distributor.
QUALITY CONTROL
A procedural control is included in the test. A red line appearing in the control region (C) is the
internal procedural control. It confirms sufficient specimen volume and correct procedural
technique.
It is recommended that a positive hCG control (containing 25-250 mIU/mL hCG) and a negative hCG
control (containing "0" mIU/mL hCG) be evaluated to verify proper test performance when a new
shipment of test devices are received.
LIMITATIONS
1. The hCG Card Pregnancy Test is a qualitative test, therefore, neither the quantitative value nor the
rate of increase in hCG can be determined by this test.
2. Very dilute urine specimens, as indicated by a low specific gravity, may not contain
representative levels of hCG. If pregnancy is still suspected, a first morning urine specimen
should be collected 48 hours later and tested.
3. False negative results may occur when the levels of hCG are below the sensitivity level of the
test. When pregnancy is still suspected, a first morning urine specimen should be collected 48
hours later and tested.
4. Very low levels of hCG (less than 50 mIU/mL) are present in urine specimen shortly after
implantation. However, because a significant number of first trimester pregnancies terminate
for natural reasons,5 a test result that is weakly positive should be confirmed by retesting with
a first morning urine specimen collected 48 hours later.
5. A number of conditions other than pregnancy, including trophoblastic disease and certain non-
trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung
cancer, cause elevated levels of hCG.6,7 Therefore, the presence of hCG in urine specimen
should not be used to diagnose pregnancy unless these conditions have been ruled out.
6. This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis
should only be made by a physician after all clinical and laboratory findings have been evaluated.
EXPECTED VALUES
Negative results are expected in healthy non-pregnant women and healthy men. Healthy pregnant
women have hCG present in their urine and serum specimens. The amount of hCG will vary greatly
with gestational age and between individuals.
The hCG Card Pregnancy Test has a sensitivity of 25 mIU/mL, and is capable of detecting pregnancy
as early as 10 days after a possible conception.
Catalogue Nr : RAPU01C040 P.I. Number : 1701256 Revision Nr : 101118/1
PERFORMANCE CHARACTERISTICS
ACCURACY
A multi-center clinical evaluation was conducted comparing the results obtained using the hCG Card
Pregnancy Test to another commercially available urine membrane hCG test. The study included 159
urine specimens: both assays identified 88 negative and 71 positive results. The results demonstrated a
100% overall accuracy of the hCG Card Pregnancy Test when compared to the other urine membrane
hCG test.
hCG Reference Method
Method Other hCG Rapid Test
Total
DIAsource Results Positive Negative
hCG Card
Pregnancy Positive 71 0 71
Test Negative 0 88 88
Total 71 88 159
Relative Sensitivity: 100%
Relative Specificity: 100%
Accuracy: 100%
SENSITIVITY AND SPECIFICITY
The hCG Card Pregnancy Test detects hCG at a concentration of 25 mIU/mL or greater. The test
has been standardized to the W.H.O. Third International Standard. The addition of LH (300
mIU/mL), FSH (1,000 mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIU/mL hCG) and
positive (25 mIU/mL hCG) specimens showed no cross-reactivity.
INTERFERING SUBSTANCES
The following potentially interfering substances were added to hCG negative and positive specimens.
Acetaminophen 20 mg/mL Caffeine 20 mg/mL
Acetylsalicylic Acid 20 mg/mL Gentisic Acid 20 mg/mL
Ascorbic Acid 20 mg/mL Glucose 2 g/dL
Atropine 20 mg/mL Hemoglobin 1 mg/dL
Bilirubin 2 mg/dL
None of the substances at the concentration tested interfered in the assay.
BIBLIOGRAPHIY
1. Batzer FR. “Hormonal evaluation of early pregnancy”, Fertil. Steril. 1980; 34(1): 1-13
2. Catt KJ, ML Dufau, JL Vaitukaitis “Appearance of hCG in pregnancy plasma following the initiation of
implantation of the blastocyte”, J. Clin. Endocrinol. Metab. 1975; 40(3): 537-540
3. Braunstein GD, J Rasor, H. Danzer, D Adler, ME Wade “Serum human chorionic gonadotropin levels
throughout normal pregnancy”, Am. J. Obstet. Gynecol. 1976; 126(6): 678-681
4. Lenton EA, LM Neal, R Sulaiman “Plasma concentration of human chorionic gonadotropin from
the time of implantation until the second week of pregnancy”, Fertil. Steril. 1982; 37(6): 773-778
5. Steier JA, P Bergsjo, OL Myking “Human chorionic gonadotropin in maternal plasma after
induced abortion, spontaneous abortion and removed ectopic pregnancy”, Obstet. Gynecol. 1984;
64(3): 391-394
6. Dawood MY, BB Saxena, R Landesman “Human chorionic gonadotropin and its subunits in
hydatidiform mole and choriocarcinoma”, Obstet. Gynecol. 1977; 50(2): 172-181
7. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross “Ectopic production of human chorionic
gonadotropin by neoplasms”, Ann. Intern Med. 1973; 78(1): 39-45
Catalogue Nr : RAPU01C040 P.I. Number : 1701256 Revision Nr : 101118/1
Consult instructions for use Manufacturer
Storage temperature Contains sufficient for n tests
Use by
In vitro diagnostic medical device
Batch code CARD Card
Catalogue number PIPETTE Pipette
Revision date : 2010-11-18
Catalogue Nr : RAPU01C040 P.I. Number : 1701256 Revision Nr : 101118/1
