Human Chorionic Gonadotropin (HCG) Test (Pregnancy Tests)
Women Pregnancy Urine Test Kit HCG Rapid Detection Cassette Urine
Test In Vitro Test Colloidal Gold
Main Features
☀ 100% Sensitivity
☀ 100% Specificity
☀ Reliable: high accurate, early detection of the presence of HCG
☀ Simple: No Instrument Required
☀ Convenient: Room Temperature Storage, Built-In Control line
☀ Fast: Results in 5-30 minutes, strong positive results may be
observed promptly within 3 minutes
☀ Certified by Authoritative Certification System and Standards
☀ Winner of "the National Rapid Diagnostic Kit for Clinical
Performance Assessment"
INTENDED USE
The HCG s/u Gold Rapid Screen Test(RST)is a chromatographic
immunoassay for the early detection of human chronic gonadotropin
(HCG) in serum/plasma or urine specimens.
PRINCIPLE
The membrane of the test device was coated with anti HCG antibodies
on the test region and goat anti mouse IgG antibodies on the
control region. During the test, urine/serum specimen is allowed to
react with the HCG monoclonal antibody-colloid gold conjugate,
which was pre-dried on the test strip. The mixture then moves
upward on the membrane chromatographically by capillary action. For
a positive specimen, the conjugate binds to the HCG forming an
antibody-antigen complex.
This complex is captured by anti HCG antibody immobilized on the
test region (T) and produces a pink color band when HCG
concentration is equal to or greater than 25mIU/ml. Absence of this
colored band in the test region suggests a negative result. To
serve as a procedural control, a colored band at the control
region(C) will always appear regardless the presence or absence of
HCG.
STORAGE
The kits should be stored at temperature 4-30°C, the sealed pouch
for the duration of the shelf life (24 months).
ASSAY PROCEDURE
Remove the device from pouch by tearing and label the device with
specimen identification.
Add 2-3 drops (70-100ul) of serum/plasma/urine to the s. Well.
Observe the result in 5-10 minutes. DO not interpret results after
10 minutes.
INTERPRETATION OF RESULTS
Negative: Only one colored band appears on the control region (C). No
colored band in the test region(T).
Positive: In addition to the control band (C), a distinct colored band also
appears in the test region (T).
Invalid: If no bands appear, or a test band appears without a control band,
the test should be repeated using a new test device.
Precision
Intra-assay: The test strips of the same lot number were used in
the specimens containing 25mIU/mL hCG. Results and color are
consistent.
Inter-assay: Three lots of test strips were used in specimens
containing 25mIU/mL hCG. Results and color are consistent.
Clinical Study
The study included 80 positive and 120 negative patient urine
specimens confirmed by routine diagnostic method and tested by
pregnancy test strip. The results showed 100% consistency.
Performance Characteristics
Analytic Sensitivity: The test will detect HCG in urine at
concentration of 25mIU/mL or greater.
Analytic Specificity: The addition of LH (500mIU/mL), FSH
(1000mIU/mL), and TSH (1000μIU/mL) to negative (0mIU/mL HCG) and
positive (25mIU/mL HCG) specimens showed no cross-reactivity.
Interference Testing
The following potentially interfering substances were added to
urine samples containing 0mIU/mL and 25mIU/mL HCG. None of the
substances at the following concentration tested interfered in the
assay.
