PROFESSIONAL MEDICAL PRODUCTS
HCG PREGNANCY RAPID TEST CASSETTE(URINE)
A rapid test for the qualitative detection of human chorionic gonadotropin
(hCG) in urine. For professional in vitro diagnostic use only
INTENDED USE
The hCG Pregnancy Rapid Test Cassette 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 (hCG) is a glycoprotein hormone produced
by the developing placenta shortly after fertilization. In normal pregnancy,
hCG can be detected in both urine and serum or plasma as early as 7 to
10 days after conception.
quently exceeding 100mIU/ml by the rst missed menstrual period,
1,2,3,4
hCG levels continue to rise very rapidly, fre-
2,3,4
and
peaking in the 100,000-200,000mIU/ml range about 10-12 weeks into pregnancy. The appearance of hCG in both the urine and serum or plasma 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 Pregnancy Rapid Test Cassette is a rapid test that qualitatively
detects the presence of hCG in urine specimen at the sensitivity of 20mIU/
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 Pregnancy Rapid Test Cassette shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH,
hLH and hTSH at high physiological levels.
PRINCIPLE
The hCG Pregnancy Rapid Test Cassette 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 uses two lines
to indicate results. The test utilizes a combination of antibodies including a
monoclonal hCG antibody to selectively detect elevated levels of hCG. The
control line is composed of goat polyclonal antibodies and colloidal gold
particles. 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 specic 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 contains anti-hCG particles and anti-hCG coated on the membrane.
PRECAUTIONS
Please read all the information in this package insert before performing the
test.
1. For professional in vitro diagnostic use only. Do not use after the expiration date.
2. The test should remain in the sealed pouch until ready to use.
3. All specimens should be considered potentially hazardous and handled in
the same manner as an infectious agent.
4. The used test should be discarded according to local regulations.
STORAGE AND STABILITY
Store as packaged at room temperature or refrigerated (2-30°C). The test
is stable through the expiration date printed on the sealed pouch. The test
must remain in the sealed pouch until use. DO NOT FREEZE. Do not use
beyond the expiration date.
SPECIMEN COLLECTION AND PREPARATION
Urine Assay
A urine specimen must be collected in a clean and dry container. A rst
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, ltered, 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
• Test cassettes
• Droppers
• Package insert
Materials required but not provided
• Specimen collection containers
• Timer
DIRECTIONS FOR USE
1. Bring the pouch to room temperature (15-30°C) before opening it. Remove the cassette from the sealed pouch and use it within one hour.
2. Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approximately 120ul) to the specimen
well of the cassette, and then start the timer. Avoid trapping air bubbles in
the specimen well. See illustration.
3. Wait for the colored line(s) to appear. The result should be read at 3
minutes.
NOTE: A low hCG concentration might result in a weak line appearing in
the test line region (T) after an extended period of time; therefore, do not
interpret the result after 10 minutes.
3 Drops of specimen
Positive Negative Invalid
INTERPRETATION OF RESULTS
(Please refer to the illustration)
POSITIVE: Two distinct colored lines appear. One line should be in the
control line region (C) and another line should be in the test line region (T).
One line may be lighter than the other; they do not have to match. This
means that you are probably pregnant.
NEGATIVE: One colored line appears in the control line region (C). No
line appears in the test line region (T). This means that you are probably
not pregnant.
INVALID: The result is invalid if no colored line appears in the control
line region (C), even if a line appears in the test line region (T). You should
repeat the test with a new test cassette.
QUALITY CONTROL
A procedural control is included in the test. A colored line appearing in the
control line region (C) is considered an internal procedural control. It conrms sufcient specimen volume and correct procedural technique. A clear
background is an internal negative procedural control. If a background color
appears in the result window and interferes with the ability to read the test
result, the result may be invalid. It is recommended that a positive hCG control (containing 20-250mIU/ml hCG) and a negative hCG control (containing
“0”mIU/ml hCG) be evaluated to verify proper test performance when a new
shipment of tests is received..
LIMITATIONS
1. The hCG Pregnancy Rapid Test Cassette is a preliminary 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 specic gravity, may
not contain representative levels of hCG. If pregnancy is still suspected,
a rst morning urine specimen should be collected 48 hours later and
tested.
3. Very low levels of hCG (less than 50mIU/ml) are present in urine specimens shortly after implantation. However, because a signicant number
of rst trimester pregnancies terminate for natural reasons,5 a test result
that is weakly positive should be conrmed by retesting with a rst morning urine specimen collected 48 hours later.
4. This test may produce false positive results. 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 should not be used to diagnose pregnancy
unless these conditions have been ruled out.
5. This test may produce false negative results. False negative results may
occur when the levels of hCG are below the sensitivity level of the test.
When pregnancy is still suspected, a rst morning urine specimen should
be collected 48 hours later and tested. In case pregnancy is suspected
and the test continues to produce negative results, see a physician for
further diagnosis.
6. This test provides a presumptive diagnosis for pregnancy. A conrmed
pregnancy diagnosis should only be made by a physician after all clinical
and laboratory ndings have been evaluated.
EXPECTED VALUE
Negative results are expected in healthy non-pregnant women and healthy
men.
Healthy pregnant women have hCG present in their urine specimens. The
amount of hCG will vary greatly with gestational age and between individuals. The hCG Pregnancy Rapid Test Cassette for Urine has a sensitivity of
20mIU/ml, and is capable of detecting pregnancy as early as 1 day after the
rst missed menses.
PERFORMANCE CHARACTERISTICS
Accuracy
A multi-center clinical evaluation was conducted comparing the results obtained using the HCG Pregnancy Rapid Test Cassette to another commercially available urine hCG Rapid test. The study included 608 urine specimens, and both assays identied 377 negative and 231 positive results. The
results demonstrated >99% overall accuracy of the hCG Pregnancy Rapid
Test Cassette when compared to the other hCG Rapid Test.
Method Other hCG Rapid Test Total Results
hCG Pregnancy
Rapid Test
Cassette
Total Results 231 377 608
Sensitivity: >99.9% (98.7%~100%)*
Specicity: >99.9% (99.2%~100%)*
Accuracy: >99.9% (99.5%~100%)*
*95% Condence Intervals
Sensitivity and Cross-Reactivity
The HCG Pregnancy Rapid Test Cassette detects hCG at a concentration of
20mIU/ml or greater. The test has been standardized to the W.H.O. International Standard. The addition of LH (300mIU/ml), FSH (1,000mIU/ml),
and TSH (1,000μIU/ml) to negative (0mIU/ml hCG) and positive (20mIU/ml
hCG) specimens showed no cross-reactivity.
Precision Intra-Assay
Within-run precision has been determined by using 10 replicates of three
specimens containing 20mIU/ml, 100mIU/ml, 250mIU/ml and 0mIU/ml of
HCG. The negative and positive values were correctly identied 100% of
the time.
Inter-Assay
Between-run precision has been determined by using the same three specimens of 20mIU/ml, 100mIU/ml, 250mIU/ml and 0mIU/ml of HCG in 10 independent assays.
Three different lots of the HCG Pregnancy Rapid Test Cassette have been
tested. The specimens were correctly identied 100% of the time.
Interfering Substance
The following potentially interfering substances were added to hCG negative and positive specimens.
Acetaminophen 20 mg/dl Caffeine 20 mg/dl
Acetylsalicylic Acid 20 mg/dl Gentisic Acid 20 mg/dl
Ascorbic Acid 20 mg/dl Glucose 2 g/dl
Atropine 20 mg/dl Hemoglobin 1 mg/dl
Bilirubin 2 mg/dl
None of the substances at the concentration tested interfered in the assay.
Results Positive Negative
Positive 231 0 231
Negative 0 377 377
BIBLIOGRAPHY
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 chorionicgonadotropin by neoplasms”, Ann. Intern Med. 1973; 78(1): 39-45
Index of Symbols
Caution: read instructions
(warnings) carefully
Manufacturer
Product code Lot number
In vitro diagnostic medical device
compliant with Directive 98/79
/ EC
In vitro diagnostic medical device Expiration date
Disposable device, do not re-use
Temperature limit
Consult instructions for use
Authorized representative in
the European community
Contains sufcient for “n” tests
Don’t use if package is
damaged
FHC-102 (29092)
Hangzhou AllTest Biotech Co., Ltd.
#550, Yinhai Street
Hangzhou Economic & Technological Development Area
Hangzhou - 310018, P.R. China
Made in China
MedNet GmbH
Borkstrasse 10 - 48163 Muenster - Germany
Imported by:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
30°C
2°C
M29092-GB-Rev.0-03.21
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