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Neonatal / hCG ELISA CE

hCG ELISA CE

solid-phase enzyme-linked immunosorbent

assay based on the principle of the double
antibody sandwich technique for quantitative
determination of human chorionic
gonadotropin (hCG) in human serum.

The three main kit components are:

1) Solid microwells pre-coated with

streptavidin,

2) hCG Calibrators,

3) Liquid hCG Enzyme Conjugate Mixture

comprised of two individual antibody
conjugates: an anti-human hCG antibody
labelled with horseradish peroxidase (HRP-
Ab) and an anti-human hCG antibody labelled
with biotin (Bio-Ab).

The CTK hCG ELISA is intended to be used

only by professionals only. Any interpretation
or use of this test result must also integrate
other clinical findings as well as on the
professional judgment of health care
providers.

Human chorionic gonadotropin (hCG) is a

glycoprotein hormone that plays an important
role in the female reproductive system. hCG is
involved in maintenance of the corpus luteum
and progesterone production, as well as
various other functions, such as development
of the umbilical cord, development of fetal
organs, angiogenesis, suppression of uterine
contractions, immunosuppression and
protection from invading cells.

hCG is detectable in the blood and urine.

Abnormally low levels of hCG during
pregnancy may indicate issues such as a
failing pregnancy, placental insufficiency,
ectopic pregnancy, fetal death, preeclampsia,
and pre-term delivery. High levels of hCG
during pregnancy may indicate multiple
pregnancies, molar pregnancy, or gestational
miscalculation. Accurate quantification of
hCG levels is very important for diagnosis and
monitoring of pregnancy. Immunoassays
utilizing hCG-specific antibodies to detect and
quantify hCG are a first-line approach that
provide accurate and reliable results. The CTK
hCG ELISA can be used for diagnosis and
monitoring of pregnancy.

PRODUCT FEATURES

PRODUCT SPECIFICATIONS

SUPPORT ORDERING

Analytical Sensitivity: 10 mIU/mL at

2-SD
Specificity: No cross-reactivity or
interference with 1000 mIU/mL TSH,
10,000 mIU/mL FSH, 1,000 mIU/mL
LH, 5,000 ng/mL PRL, 1 mM/mL
Bilirubin, 10 µg/mL Hemoglobin, 10
µg/mL Lipids
Accuracy: correlation coefficient
0.979 at normal range or 0.960
during early pregnancy with a
reference method
Intra Assay Precision: CV ≤ 6.5%
Inter Assay Precision: CV ≤ 10.5%
Hook Effect: no hook effect up to
50,000 mIU/mL

FOR EXPORT ONLY

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Phone: 858.457.8698 | Email: info@ctkbiotech.com

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