hCG Test for the early detection of Pregnancy
Sandwich immunoassay in cassette format, individually wrapped, for the fast detection of
human chorionic gonadotropin (hCG) in urine. In vitro diagnostic agent for professional use.
INTENDED USE
The ultimed hCG Cassette Pregnancy Test is a rapid chromatograph immunoassay for the qualitative detection of hCG in urine
to aid in the early detection of Pregnancy The test indicates if a defined cut-off value is exceeded or not.
SUMMARY
The human chorionic gonadotropin hormone (hCG) is a glucoprotein consisting of an  and a -subunit, which is passed
initially by the fertilised ovum and after implantation of the ovum in the mucous membrane of the uterus by this into the maternal
blood circulation. In the normal course of pregnancy, hCG can be detected in the serum around seven days after fertilisation of
the ovum (1 – 4). The hCG concentration has frequently risen above 100 mIU/ml 14 days after fertilisation of the ovum,
therefore at the time when the otherwise expected period is missed. Concentration peaks of 200,000 mIU/ml and more can be
observed in the 10th to 12th week of pregnancy (2 – 4). The early rise of the hCG concentration even before the period is
missed qualifies the hCG hormone for the early detection of pregnancy.
The ultimed hCG pregnancy test is set to a sensitivity of 25 mIU/ml. Both subunits are acquired by complex formation in the
course of the test. Monoclonal antibodies, which because of their immunological specificity do not interact with the structurally
related human follicle-stimulating hormone (hFSH), human luteinising hormone (hLH) and human thyroid-stimulating hormone
(TSH) if these are present in physiological concentrations, are used in the test for selective detection of hCG concentrations in
urine samples.
TEST PRINCIPLES
The ultimed hCG pregnancy test is a one-step sandwich immunoassay for the fast detection of hCG in urine. The special
membrane is placed in front of a reaction pad which contains colloidal gold particles coated with monoclonal anti-hCG
antibodies. If a sample is applied, the colloidal gold particles dissolve in the liquid sample. If the sample contains the hCG
hormone, this is bonded to the monoclonal antibodies marked with colloidal gold particles. The dissolved gold particles are
transported through the membrane due to the capillary forces effective in the special membrane. In the area of the T-line, the
anti-hCG antibodies immobilised there form the complex of hCG and colloidal gold. A more or less intensive red line is formed
depending on the hCG concentration. The surplus colloidal gold particles are then bonded in the area of the C-line by the
antibodies immobilised there, so that a red line also becomes visible in this area. This line serves as an internal functional check
and must be formed in every test. If no, or only very little, hCG is contained in the sample (< 25 mIU/ml), the hormone-gold
particle complex is not formed or it is formed in insufficient amount to generate a visible red line in the area of the T-line.
STORAGE AND STABILITY
The ultimed hCG pregnancy test can be stored at room temperature (2° to 30°C). The test can be used up to the time printed on
the packaging. The test cassette must be kept in the packaging foil until immediately before use.
NOTES
For in-vitro diagnostics use only
Single use only
Do not use after expiry date.
Do not use if the protective foil is damaged. The test cassette must reach room temperature before use.
MATERIALS PROVIDED
1. Test cassette with coated special membrane and sample dropper pipette in sealed protective foil.
2. Instructions for use.
MATERIALS REQUIRED BUT NOT PROVIDED
1. Sample collection cup ( available from Omega Diagnostics Irl.)
2. Timer
URINE SPECIMEN COLLECTION
As the highest hormone concentrations are present in the morning , morning urine should be used if possible for early detection
of pregnancy.
Note: urine specimens and all materials that have been in contact with urine should be considered, treated and disposed off as
infectious material. A contact with the skin is to be avoided by wearing protective gloves and proper protective clothing.
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DIRECTIONS FOR USE
The urine specimen, test cassette and any controls should be at room temperature before the test is performed. Open
the protective foil shortly before performing the test, as the test membrane is sensitive to humidity. Use the dropper
/pipette enclosed in each pouch for applying the sample to the cassette.
1.
2.
3.
4.
5.
Mark the test card with the relevant patient id number directly after it is taken out of the protective foil.
Using the enclosed disposable sample dropper, drop 3 drops of sample (~ 120 µl) into the sample opening (S) of the test
card.
Wait until the chromatography has finished i.e. that the liquid front has passed the evaluation window.
Evaluate the test after 3-5 minutes. The confirmation of a negative result should be done at 10 minutes.
It is important that the background is clear when the result is read.
Note: The ultimed hCG pregnancy test is checked continuously with regard to quality, but it is recommended that an internal
Quality control is made with a control solution.The necessary control solutions for internal quality control ( Urinalysis Controls)
are available from Omega Diagnostics (info@omegairl.com) as required.
INTERPRETATION OF THE TEST RESULTS
positive
negative
invalid
invalid
Reproductions may vary from original!
Positive (hCG > 25 mIU/ml)
Reddish discolouration is visible both in the area of the T-line and in the area of the C-line. The intensity of the T-line depends on
the concentration of the hCG and is usually less than that of the C-line. The different intensities of the T-line are not suitable for
quantitative measurement of the hormone concentration.
Negative (hCG < 25 mIU/ml)
Red discolouration is present only in the area of the C-line.
Invalid
If, after 10 minutes. a red line can be seen neither in the T area nor in the C area or only in the test area, then the test must be
classified as invalid and it must be repeated with a new test cassette. It may be necessary to check the affected test batch with
a control solution.(Urine Control available at info@omegairl.com)
NOTE ON INTERPRETATION OF THE TEST RESULTS
In the case of an expected pregnancy, a negative result should be checked 2 - 3 days later with a new urine specimen
or checked with a quantitative Laboratory test.
Borderline cases, in which only a weak reddish (T- line) appears, should be checked 2 - 3 days later with a new urine
specimen. If on repeated testing you receive a definite negative result, this could indicate a miscarriage
LIMITATIONS OF THE TEST METHOD
A rise in hCG concentration is not attributable to pregnancy in all cases. Neoplastic processes can also bring about a rise in the
hCG concentration.
Urine samples with low specific gravity can contain too little hormone, so that repetition 2 to 3 days later with morning urine is
recommended.
The ultimed hCG pregnancy test is a diagnostic test, the result should be confirmed by further clinical examination results by
the attending physician.
Medication taken in the course of antibody therapy can falsify the result.
At very high hCG concentrations (~ 200,000 mIU/ml) the free hCG can block the formation of a red line in the T area. In such
cases, repeat the test with a diluted sample (1:10 or 1:20).
Heterophilic antibodies as well as non-specific protein binding can lead to false positive results. If the test result does not fit in
the clinical picture, then the test should be repeated with another method.
EXPECTD VALUES
The ultimed hCG pregnancy test produces a negative result (hCG < 25 mIU/ml in healthy, not pregnant women and healthy
men. At the beginning of pregnancy the hCG concentration doubles on average every 2 - 3 days. Concentrations around 20
mIU/ml can be observed after 8 - 10 days. The highest concentration is reached in the 8th to 10th week and the concentration
then drops, so that only slightly elevated values are present at the end of pregnancy.
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QUALITY CONTROL
The ultimed hCG pregnancy test contains an internal control, the C-line, which indicates the effectiveness of the reagents. In
addition, the function of the special membrane can be checked by reference to the background colour. If the membrane has a
clear white background after the test is performed, then chromatography has occurred without errors.
The ultimed hCG pregnancy test is checked continuously with regard to its quality, but it is recommended that internal laboratory
control is performed using a quality control solution when a new batch is used or if the test is performed for the first time.
Liquid urine quality controls containing hCG are available from Omega Diagnostics (Ireland) Ltd.
SPECIFICITY
The possible interactions and therefore false positive results have been checked with the structurally similar hormones like
human follicle-stimulating hormone (hFSH), human luteinizing hormone (hLH) and human thyroid-stimulating hormone (hTSH).
At the below mentioned concentrations there was no discolouration observed at the indicated concentrations in the test region.
hLH
hFSH
300
1000
no
no
hTSH
1000
no
CROSS REACTIONS
The following substances were added to both positive and negative urine:
Acetaminophene
Acetyl salicylic acid
Ascorbic acid
Atropine
Bilirubin
20
20
20
20
2
mg/ml
mg/ml
mg/ml
mg/ml
mg/dl
Caffeine
Gentisic acid
Glucose
Haemoglobin
20
20
2
1
mg/ml
mg/ml
g/dl
mg/dl
No cross reactions were observed.
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 chorio nic 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
Manufacturer :
ulti med Products (Deutschland) GmbH
Reeshoop 1 • 22926 Ahrensburg
Germany
Phone: +49 +4102 - 80090
Distribution:
Omega Diagnostics (Ireland) Ltd.
Unit 14, Bullford Business Campus
Kilcoole, Co. Wicklow.
Ireland
Phone : + 353 1 2878158
Email : info@omegairl.com
Revision October 2011
RD
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