IHR PARTNER FÜR IN VITRO DIAGNOSTIKA
hCG Pregnancy test strip HCG-R20
INTENDED USE MATERIALS REQUIRED BUT NOT PROVIDED
The Diagnostik Nord hCG Pregnancy test strip is a rapid, self performing, two site • Specimen collection containers
sandwich immunoassay for the determination of human chorionic gonadotropin • Timer
(hCG), a marker for pregnancy, in urine specimens. The test is intended as an aid
in the detection of pregnancy by professional users, showing a visual qualitative
result. STORAGE AND STABILITY
Store refrigerated (2-8°C) or at room temperature (not above 30°C) in the tightly
closed tube. Under these conditions the test is stable within the expiration date
SUMMARY printed on the label. DO NOT FREEZE or use beyond the expiration date. Ensure
Human chorionic gonadotropin (hCG), a glycoprotein hormone secreted by viable that the tube is closed tightly after each usage.
placental tissue during pregnancy, is excreted in urine approximately 20 days
after the last menstrual period. The levels of HCG rise rapidly reaching peak levels
after 60-80 days. The appearance of hCG in urine soon after conception and its WARNINGS AND PRECAUTIONS
rapid rise in concentration makes it an ideal marker for the early detection and
confirmation of pregnancy. However, elevated hCG levels are frequently associated • For in vitro diagnostic use by professionals only.
with trophoblastic and non-trophoblastic neoplasms and hence these conditions • Use each test strip only once
should be considered before a diagnosis of pregnancy can be made. The hCG test • Do not use after the expiration date
detects the presence of hCG in urine specimens, qualitatively, at concentrations as • Do not use test if tube has been damaged. Close tube immediately after use to
low as 20mlU/ml in less than five minutes. The test utilizes monoclonal antibodies to minimize the access of humidity.
selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, • Bring all reagents to room temperature (15-30°C) before use.
the Diagnostik Nord hCG pregnancy test strip shows no cross-reactivity interference • Handle all specimens as if they contain infectious agents. Observe established
with the structurally related glycoprotein hormones hFSH, hLH and hTSH at precautions against microbiological hazards throughout testing and follow
physiological levels. standard procedures for proper disposal of specimens.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
Wear protective clothing such as laboratory coats, disposable gloves and eye
PRINCIPLE protection when specimens are being tested.
• Humidity and high temperature can adversely affect results.
The Diagnostik Nord hCG Pregnancy test strip is a sandwich immunoassay and • The components of the test (e.g. antibodies/chemicals) do not cause any danger
detects hCG with the aid of two specific monoclonal antibodies against the protein. if the test is used according to the instructions.
After the addition of the sample, a color-labelled antibody specifically binds to hCG • Read the entire procedure carefully before performing any tests.
if it is present in the sample. When the hCG-antibody-complexes migrate upward
on the membrane by capillary action, they are captured with the aid of the other
specific anti-hCG-antibody at the test result line region of the test. A red test result SPECIMEN COLLECTION AND PREPARATION
line is generated. If no hCG is present the color labelled antibody cannot bind
at the test result line region. No red test result line is formed. So the presence of The test is intended for the use with human urine samples. From the first day of
a colored test result line indicates a positive result, while its absence indicates a the missed period urine samples from any time of the day can be used with the
negative result. To serve as a procedural control, a colored line will always appear Diagnostik Nord hCG test. However, at the very beginning of the pregnancy, first
in the control line region indicating that proper volume of specimen has been morning urine might be preferable in order to get more intense test result lines. In
added and membrane wicking has occurred. the morning urine contains the highest hCG concentration as hCG enriches in the
urine over night.
Specimens should be collected in clean glass or plastic containers. Avoid cross-
SET-UP OF THE TEST STRIP contamination of samples by using a new specimen collec¬tion container for each
sample. Generally urine can be used for testing without any further preparation.
In the following picture the set-up of the test strip is depicted. At the left site you can If testing is delayed, the urine specimens may be stored at 2º to 8ºC for up to 48
see the contact site for urine with a mark, that indicates the maximum immersion hours. For long term storage, specimens should be kept below -20°C.
depth. Right next to it is the reaction zone with the test- (T) and control- (C) region. Turbid specimens should be centrifuged or allowed to settle and only the clear
At the right site you can see the handle with the abbreviation of the analyte (hCG). supernatant should be used for testing. Specimens must be brought to room
Here the test strip can be hold with your fingers. Do not touch the tip or the white temperature prior to testing. Frozen specimens must be completely thawed and
reaction zone to avoid contaminations. mixed well before use. Avoid repeated freezing and thawing of specimens.
Samples, controls and the tube containing the test strips must be brought to room
temperature (15 30°C) before starting the assay. Do not open refrigerated tubes to
Contact site Maximum reaction zone Handle with avoid a condensation of moisture on the test strips.
urine immersion with test (T) and name of test
depth control (C) region Open the tube and remove one strip by holding it at the handle with the
hCG imprints. Close the tube after having removed the strip. The dipstick
should now be used immediately but latest within one hour.
REAGENTS AND MATERIALS SUPPLIED 2 Hold the test strip vertically at the handle. Avoid touching the reaction zone
• Tube with 20 test strips. Please note that the tube contains a desiccant in the lid with your fingers to avoid contaminations
to keep away humidity from the tests. 3 Dip the tip of the strip into the urine sample.
• 1 package insert Ensure that the strip is not submerged beyond
the max line. Any direct contact of liquid with
the white reaction zone must be avoided.
4 Observe the release of the color labeled antibody. It can be seen as a pink
moving liquid front on the membrane. Depending on the sample, it might
take 10-15 seconds for the liquid front to appear in the reaction zone.
5 When the liquid front has reached the upper end of the membrane remove
the test strip from the liquid and place it horizontally on a flat surface.
Alternatively the dipstick may be left to stand in the specimen for the entire
duration of the test procedure. Ensure that only the tip remains submerged
in the sample.
6 Start the timer.
IHR PARTNER FÜR IN VITRO DIAGNOSTIKA
Read test result after 2-5 minutes by looking ranging between 40,000 and 230,000 mIU/ml (Thomas 2005). After this the hCG
at the pattern of lines that have appeared at concentration declines until it reaches values between 5000 and 65.000 mIU/ml in
the reaction zone. Do not interpret the test the 3rd trimester. Following delivery, hCG levels rapidly decrease and usually return
result later than 15 minutes after the addition to normal within several weeks after parturition.The Diagnostik Nord hCG test strip
of the sample. Low hCG concentrations may 12 has a sensitivity of 20 mIU/mL for urine and is capable of detecting pregnancy as
produce very weak T lines.after a prolonged 9 3
early as 1 day after the first missed menses.
incubation time. Such low hCG concentrations 6
might be present in non-pregnant individuals PERFORMANCE CHARACTERISTICS
in rare cases. Therefore, do not interpret the
result later than 15 minutes in order to avoid Analytical sensitivity
false positive test results. The analytical sensitivity of Diagnostik Nord hCG Pregnancy Test is 20 mIU/mL
(based on the 4th IRP of HCG).
The Diagnostik Nord hCG Pregnancy Test does not show a “high dose Hook” or
INTERPRETATION OF RESULT “Prozone Effect” up to 600 IU/mL. This means that under physiological conditions
no high dose hook effect is to be expected throughout the complete pregnancy. The
Negative Only one colored line appears in the working range of the Diagnostik Nord hCG Pregnancy Test is 20 mIU/mL up to
result: control region (C). No colored line 600,000 mIU/mL.
appears in the test region (T). MAX
This result indicates that the assay Analytical Specificity
has not detected hCG. The specificity of the Diagnostik Nord hCG Rapid Test Device (Urine) was determined
in cross reactivity studies with known amounts of Luteinizing Hormone (hLH), Follicle
Positive Two colored lines appear on the
Stimulating Hormone (hFSH) and Thyroid Stimulating Hormone (hTSH). When tested
result: membrane. One line appears in the
at more fold physiologically expected concentrations, all hormones gave clear
control region (C) and another line
negative result. So in healthy individuals no cross reactivities with the structurally
appears in the test region (T).
related hormones hLH, hFSH, and hTSH are to be expected.
This result indicates that hCG has
been detected by the assay.
The results obtained with the hCG test correlated very well (> 99.9 %) when run in
Note: The intensity of the color in the
MAX parallel with another commercially available CE approved pregnancy test, using
test region (T) may vary depending on
known positive and negative specimens.
the concentration of hCG present in the
specimen. Therefore, any shade of color
in the test region that has appeared LITERATURE
within the specified reading time should 1. Alfthan H, Haglund C, Dabek J, Stenman U-H. Concentrations of Human Choriogonadotropin, Its /3-Subunit,
be considered positive. Please note that and the Core Fragment of the p-Subunit in Serum and Urine of Men and Nonpregnant Women. Clin Chem
this is a qualitative test only, and cannot 1992; 38(10) 1981-1987
2. Braunstein GD, Vaitukaitis JL, Carbone PP, Ross GT. Ectopic production of human chorionic gonadotrophin by
determine the concentration of hCG in the neoplasms. Ann Intern Med. 1973 Jan; 78(1): 39-45.
specimen. 3. Catt KJ, Dufau ML, Vaitukaitis JL. Appearance of hCG in pregnancy plasma following the initiation of implanta-
tion of the blastocyst. J Clin Endocrinol Metab. 1975 Mar; 40(3): 537-40.
Invalid Results from any test which has not 4. Braunstein GD, Rasor J, Danzer H, Adler D, Wade ME. Serum human chorionic gonadotropin levels throughout
result: produced a control line at the specified MAX
normal pregnancy. Am J Obstet Gynecol. 1976 Nov 15; 126(6): 678-81.
5. Batzer FR. Fertil Steril. Hormonal evaluation of early pregnancy. 1980 Jul; 34(1): 1-13.
reading time must be discarded. Please 6. Lenton EA, Neal LM, Sulaiman R. Plasma concentrations of human chorionic gonadotropin from the time of
review the procedure and repeat with implantation until the second week of pregnancy. Fertil Steril. 1982 Jun; 37(6): 773-8.
a new test. If the problem persists, 7. Labor und Diagnose, Eds. Lothar Thomas, 6th edition (TH-books Verlagsgesellschaft mbH, Frankfurt/Main,
2005) Seite 1516 ff
discontinue using the kit immediately and MAX
contact your local distributor.
QUALITY CONTROL Content
A procedural control is included in the test. A red line appearing in the control
region (C) is considered an internal positive procedural control. For in-vitro diagnostic use only Lot number
External controls are not supplied with the kit. It is recommended that positive and
negative controls should be tested as a good laboratory practice to confirm the test For single use only Expery date
procedure and to verify proper test performance.
Carefully read package insert Store at room temperature
LIMITATIONS OF THE TEST
• The hCG Rapid Test Device (Urine) is for professional in vitro diagnostic use,
Rev.: 03.02.2010 (JM)
and should only be used for the qualitative detection of human chorionic
• Very dilute urine specimens, exhibiting low specific gravity, may not contain
representative levels of hCG especially at the very beginning of pregnancy. If PRODUCER
pregnancy is still suspected after a negative result, a first morning urine sample
should be obtained 48-72 hours later and tested. If pregnancy is suspected and
the test continues to produce negative results, other means of diagnosis should Diagnostik Nord Phone : +49 (0)385/208409-0
be applied by the physician. Wallstraße 6 Fax: +49 (0)385/208409-29
• A number of conditions other than pregnancy, including trophoblastic disease 19053 Schwerin Email: firstname.lastname@example.org
and certain non-trophoblastic neoplasms including testicular tumors, prostate Germany Internet: www.diagnostik-nord.de
cancer, breast cancer, and lung cancer, might cause elevated levels of hCG
(>10 mIU/mL). Therefore, the presence of hCG in urine as determined by using
the hCG Rapid Test Device (Urine) should not be used to diagnose pregnancy
unless these conditions have been ruled out.
• A high percentage of early pregnancies become naturally terminated. Such
spontaneous aborts are frequently seen as a delayed bleeding. Nevertheless
they might lead to hCG concentrations that are detected by the assay and lead
to positive results until the hCG concentration declines again to normal levels.
• As with all diagnostic tests, a confirmed pregnancy diagnosis should only
be made by a physician after all clinical and laboratory findings have been
7-10 days after conception the hCG concentration in pregnant women starts to
rise very rapidly. At the first day of the missed period concentrations up to 100
mIU/ml may be reached. hCG values peak around the 10th week of pregnancy