SERATEC HCG-C2 bruksanvisning

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PDF bruksanvisning
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bruksanvisningSERATEC HCG-C2
Gesellschaft für Biotechnologie mbH
Ernst-Ruhstrat-Str. 5
D -37079 Göttingen, Germany
Phone: +49 (0)551/504 800 • Fax: +49 (0)551/504 80 80 • e-mail:, web:
Combo user instruction page1


COMBO Pregnancy Test

A visual one-step immunoassay for the qualitative detection
of human chorionic gonodotropin in serum or urine.
For professional In Vitro diagnostic use only.
For the rapid determination of human chorionic gonadotropin (hCG) in
urine and serum specimens. The test kit is used to obtain a visual,
qualitative result and is intended for professional use.
Human chorionic gonadotropin (hCG) is a glycoprotein hormone se-
creted by the developing placenta shortly after fertilization. In normal
pregnancy, hCG can be detected in serum or urine as early as 7 days
following conception (1-4) using sufficiently sensitive test methods. The
concentration of hCG continues to rise rapidly, frequently exceeding
100 mIU/mL by the first missed menstrual period (2-5) and peaking in
the 30,000 - 100,000 mIU/mL range by 10 - 12 weeks into pregnancy.
After this the hCG concentration declines until it reaches values at
about one tenth of the maximum for the remainder of the pregnancy.
Following delivery, hCG levels rapidly decrease and usually return to
normal within several weeks after parturition. The appearance of hCG
in both, serum and urine, soon after conception and its subsequent rise
in concentration during early gestational growth makes it an excellent
marker for the early detection of pregnancy.
Healthy men and healthy non-pregnant women do not exhibit detect-
able hCG levels with the SERATEC
COMBO hCG test. However,
elevated serum hCG levels comparable to those observed in early
pregnancy may also be associated with trophoblastic or non-
trophoblastic neoplasms such as hydatidiform mole, choriocarcinoma.
Therefore, the possibility of such diseases should be ruled out before a
positive hCG result is considered diagnostic for pregnancy.
COMBO hCG device is a rapid lateral flow test for the
detection of hCG at a level of more than 20 mIU/mL. The test utilizes
monoclonal antibodies as active compounds to selectively detect ele-
vated levels of hCG. The immunological specificity of the test kit virtu-
ally eliminates cross-reactivity interference from the structurally related
glycoprotein hormones hFSH, hLH and hTSH at physiological levels.
COMBO hCG device is a chromatographic immuno-
assay (CIA) for the rapid qualitative determination of hCG in serum or
urine. The membrane of the test is precoated with anti-alpha hCG
capture antibody on the test line region and goat anti-rabbit antibodies
on the control line region. A glass fibre pad downstream of the mem-
brane contains dried anti-beta-hCG antibody that has been labelled with
gold-conjugate. It can bind to hCG if present in the sample. The pad
also contains gold-conjugated rabbit-antibodies that are a part of the
control reaction.
During testing the dried components are mobilized by the liquid and
move upwards by capillary action. In the presence of hCG the colored
hCG-antibody-cold-conjugate complex is captured by the immobilized
anti-hCG-antibody on the membrane (sandwich complex) resulting in a
red-colored line in the test line region. Independent on the presence of
hCG the gold labelled rabbit-antibody will bind in the control line region
to form the red-colored control line.
This means that hCG positive samples result in the formation of two
colored lines in the test line (T) and control line region (C), whereas
hCG negative samples only exhibit one colored line in the control line
region. The appearance of the control line confirms the proper capillary
flow and the correct handling of the test device.
The test kit is to be stored at refrigeration (+2-8°C) or at room tempera-
ture (up to 30°C) in the sealed pouch for the duration of the shelf life.
Do not use beyond expiration date.
Test devices with disposable pipettes
One instruction leaflet
Specimen collection containers


The test device is standardized to the recent WHO standard (4
75/589). The appearance of the control line serves as procedural con-
trol and indicates proper performance and reactive reagents.
However, good laboratory practices recommends the use of external
specimens to ensure proper kit performance. Each day of testing, two
levels of commercial controls should be tested with the SERATEC
hCG test devices. The two levels of controls should consist of a nega-
tive control and a positive control containing low levels of hCG. The use
of the low level positive control will assure that the test devices have
not been adversely affected and are detecting hCG at the stated sensi-
tivity of the test system.
For single in-vitro diagnostic use.
For professional use only.
Urine and serum specimens may be potentially infectious. Proper
handling and disposal methods should be established.
Avoid cross-contamination of samples by using new specimen collec-
tion containers and specimen pipettes for each sample.
Do not use test device if the pouch is damaged
The components of the test that are of animal origin (e.g. antibodies)
do not cause any danger if the test is used according to the instruc-
Reliable test results can be expected on the first day of the missed
Urine samples
The urine specimen must be collected in a clean, dry container. Speci-
mens collected at anytime may be used, however, the first morning
urine generally contains the highest concentration of hormone. Urine
specimens may be refrigerated (2-8°C) and stored up to 72 hours prior
to assay. If samples are refrigerated, they must be equilibrated to room
temperature before testing. Urine samples exhibiting visible precipitates
should be filtered, centrifuged or allowed to settle and clear aliquots
obtained for testing.
Serum samples
No special preparation of the patient specimen is required. Limited
sample studies indicated that a plasma sample prepared from EDTA
can be used instead of serum. Serum not assayed immediately must
be stored in the refrigerator (2-8°C, up to 72 hours) or frozen (-20°C, for
up to 3 months). Do not freeze and thaw sample repeatedly. Grossly
hemolyzed samples should not be used.
1. Review Specimen Collection instructions. Test device, patient`s
samples, or controls should be brought to room temperature ( 18 -
30°C) prior to testing.
2. Remove the test device from its protective pouch (bring the device to
room temperature before opening the pouch to avoid condensation of
moisture on the membrane). Label the device with patient or control
3. Draw the sample to the line marked on the pipette (approximately 0.1
mL). Hold the pipette in a straight up and down position - not an an-
gle. Dispense 3 drops (approximately 0.1 mL) of the specimen or
control into the sample well. For each sample or control, use a sepa-
rate pipette and device.
4. Wait for the colored lines to appear in the test area. Depending on
the concentration of hCG, positive results may be observed in as short
as 40 seconds. However, to confirm negative results, the complete
reaction time (5 min) is required. Do not interpret results after 5 min-

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