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.