hCG Card Pregnancy Test

RAPU01C040

DIAsource ImmunoAssays S.A. - Rue du Bosquet, 2 - B-1348 Louvain-la-Neuve - Belgium

Version : 190717-1
 History

Resume of change :

Previous Version : Current Version :

180709-1 190717-1

Kit can be used with urine samples Kit can be used with urine or serum or
plasma samples

: 180709-1 Version : 190717-1

P.I. Number : 180709-1 P.I. Number cleared

No history History added

 hCG Card Pregnancy Test en
A rapid test for the qualitative detection of
human chorionic gonadotropin (hCG) in serum/plasma/urine

In vitro diagnostic agent for professional use

RAPU01C040
IN VITRO DIAGNOSTIC
DIAsource ImmunoAssays SA - Rue du Bosquet 2, B-1348 Louvain-la-Neuve, Belgium - Tel: +32 10 84 99 11 - Fax : +32 10 84 99 90

INTENDED USE
The DIAsource hCG Cassette is a rapid chromatographic immunoassay for the qualitative detection of human
chorionic gonadotropin in serum or plasma or 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 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 DIAsource hCG Cassette is a rapid test that qualitatively detects the presence 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 DIAsource hCG
Cassette shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH
and hTSH at high physiological levels.

TEST PRINCIPLE
The DIAsource hCG Cassette is a rapid chromatographic immunoassay for the qualitative detection of human
chorionic gonadotropin in urine or plasma or serum 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 urine specimen to the specimen well, 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.

PRECAUTIONS
⚫ For professional in vitro diagnostic use only. ⚫ The test should remain in the sealed pouch until
ready to use.
⚫ For single use only. Do not reuse. ⚫ Do not use after the expiration date.
⚫ All specimens should be considered potentially ⚫ The used test should be discarded according to
hazardous and handled in the same manner as an local regulations.
infectious agent.
⚫ The Test Cassette must reach room temperature in ⚫ Avoid cross-contamination of specimens by using
order to avoid deactivation of special membrane a new specimen collection container for each
by condensation from air humidity. specimen obtained.
⚫ Do not use if protective pouch is damaged.

Catalogue Nr : RAPU01C040 Revision Nr : 190717-1

 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 label of the sealed pouch. The test must remain in the closed pouch until use.
⚫ Do not freeze. ⚫ Do not use beyond the expiration date.

MATERIALS PROVIDED MATERIALS REQUIRED, BUT NOT PROVIDED

CARD 10 x Test Cassettes ⚫ Specimen collection container
PIPETTE 10 x Droppers (inside pouch) ⚫ Timer
⚫ Package insert

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.
Serum or plasma
Blood should be collected aseptically into a clean tube without anticoagulants (Serum) or with anticoagulants
(Plasma). Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Use clear non-
hemolyzed specimens when possible.

SPECIMEN STORAGE
Urine or serum or plasma 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.

DIRECTIONS FOR USE

1. Bring the pouch to room temperature (15-30°C) before opening it. Remove the test 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 or serum or plasma (approximatively 120µl) to the specimen well of the cassette, and then start the
timer. Avoid trapping air bubbles in the specimen well.
3. Wait for the colored line(s) to appear. Read the result at 3 minutes when testing urine specimen, or at 5
minutes when testing a serum or plasma specimen.
Note: A low hCG concentration might result in a weak line appearing in the test line region (T) after an extended
period of time.
Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS
(Please refer to the illustration above)
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.

Catalogue Nr : RAPU01C040 Revision Nr : 190717-1

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 confirms sufficient 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 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 tests is received.

LIMITATIONS
1. The DIAsource hCG 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 diluted 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. Very low levels of hCG (less than 50mIU/mL) are present in urine specimens 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.
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 first 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 confirmed pregnancy diagnosis should only be
made by a physician after all clinical and laboratory findings 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 DIAsource hCG Cassette for urine has a sensitivity of 25 mIU/mL, and is capable of detecting
pregnancy as early as 1 day after the first missed menses.

PERFORMANCE CHARACTERISTICS
Accuracy
A multi-center clinical evaluation was conducted comparing the results obtained using the DIAsource hCG
Cassette to another commercially available urine hCG Rapid test. The urine study included 608 specimens, and
both assays identified 377 negative and 231 positive results. The serum or plasma study included 308 specimens,
and both assays identified 240 negative and 68 positive results. The results demonstrated >99% overall accuracy
of the DIAsource hCG Cassette when compared to the other urine and serum or plasma hCG Rapid Test.
hCG Reference Method (Urine)
Method Other hCG Rapid Test (urine) Total
DIAsource Results Positive Negative Results
hCG Positive 231 0 231
Cassette Negative 0 377 377
Total Results 231 377 608

Sensitivity: ＞99.9% (98.7%~100%)*

Specificity: ＞99.9%(99.2%~100%)*
Accuracy: ＞99.9 %( 99.5%~100%) * * 95% Confidence Intervals

hCG Reference Method(Serum or Plasma )

Other hCG Rapid Test
Method Total
(serum/plamsa)
Results
DIAsource Results Positive Negative
hCG Positive 68 0 68
Cassette Negative 0 240 240
Total Results 68 240 308

Catalogue Nr : RAPU01C040 Revision Nr : 190717-1

 Sensitivity: ＞99.9% (95.7%~100%)*
Specificity: ＞99.9%(98.8%~100%)*
Accuracy: ＞99.9 %( 99.0%~100%) * * 95% Confidence Intervals

Tests were performed with serum and found to be positive or negative as reported. Plasma specimens from the
same individuals were tested with The hCG Pregnancy Rapid Test Cassette to validate the efficacy with plasma
specimens.

Sensitivity and Cross-Reactivity

The hCG Cassette detects hCG at a concentration of 25 mIU/mL or higher. The test has been standardized to the
W.H.O. 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.

PRECISION
Intra-Assay
Within-run precision has been determined by using 10 replicates of four specimens containing 25 mIU/mL,100
mIU/mL, 250 mIU/mL and 0 mIU/mL of hCG. The negative and positive values were correctly identified 100%
of the time.

Inter-Assay
Between-run precision has been determined by using the same four specimens of 25 mIU/ml,100
mIU/ml,250mIU/ml and 0 mIU/ml of HCG in 10 independent assays. Three different lots of the hCG Cassette
have been tested. The specimens were correctly identified 100% of the time.

Interfering Substance
The following potentially interfering substances were added to hCG negative and positive specimens.
None of the substances at the concentration tested interfered in the assay.

Acetaminophene 20mg/dL Atropine 20mg/dL Gentesin acid 20mg/dL

Acetylsalicylic acid 20mg/dL Bilirubine 2mg/dL Glucose 2g/dL
Ascorbic acid 20mg/dL Caffeine 20mg/dL Hemoglobine 1mg/dL
Bilirubin (serum or plasma) Triglycerides (serum or plasma)
40mg/dl 1,200mg/dl

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 chorionic gonadotropin
by neoplasms”, Ann. Intern Med. 1973; 78(1): 39-45

Attention, see instructions for

Tests per kit Authorized Representative
use

For in vitro
Use by Do not reuse
diagnostic use only

Store between 2-30°C Lot Number Catalog #

Do not use if package is

Manufacturer Consult Instructions for Use
damaged

Revision date : 2019-07-17

Catalogue Nr : RAPU01C040 Revision Nr : 190717-1