Safety And Professional HCG Pregnancy Test Kit

HCG Pregnancy Test Kit (Colloidal Gold) - Professional & Accurate Testing

【Intended Use】
This product is used for the qualitative detection of human chorionic gonadotropin (HCG) in human urine to aid in the detection of pregnancy. It provides rapid and reliable results for professional users, including laboratories and near-patient clinical testing.

【Principle】
Based on colloidal gold immunochromatographic technology. HCG in the sample binds to the colloidal gold-conjugated β-HCG-mAb to form a complex. This complex migrates on the membrane and is captured by the immobilized α-HCG-mAb (Test line T), forming a burgundy band. The Control line (C), coated with goat anti-mouse IgG, verifies proper procedure and reagent validity.

【Performance Characteristics】

• Sensitivity: Limit of Detection is 10mlU/mL.
• Accuracy: Comparison study with a commercially available test (n=250) showed >99% agreement.
• Specificity: No cross-reactivity with LH (500mlU/mL), FSH (1,000mlU/mL), or TSH (1,000uIU/mL).
• Interference: Different urine pH (3-10) and specific gravity (1.002-1.030) have no effect. No interference from common substances.
• Hook Effect: No obvious Hook effect was observed at HCG concentrations up to 200,000mlU/mL.

【Procedure Specifications】

1. Specimen Collection: Collect fresh urine in a clean container. Specimens with visible particles should be centrifuged, filtered, or settled. If not tested immediately, samples can be stored at room temperature for 4 hours or at 2-8°C for up to 48 hours. Refrigerated specimens must be equilibrated to room temperature before testing.
2. Testing Procedure: Prior to testing, bring unopened test devices and specimens to room temperature. Remove the test from the sealed pouch and use it immediately. Follow the instructions strictly according to the format used (Strip/Cassette/Midstream).
3. Result Interpretation: Read results at 3 minutes. Do not interpret after 10 minutes. The Control line (C) MUST appear for the test to be valid.

【Limitations】

1. This is a qualitative test. It cannot determine quantitative HCG values or the rate of increase.
2. It is not used for the diagnosis of ectopic pregnancy or missed abortion.
3. Conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms (e.g., breast cancer, lung cancer), can cause elevated hCG.
4. This test does not reliably detect hCG degradation products (e.g., free-beta hCG). Results may disagree with quantitative assays.

【Storage & Stability】
Store in the sealed pouch at 4-30°C in a dry place. The shelf life is 36 months. Do not freeze. Use within 60 minutes after opening the pouch.

【Important Precautions】

• For IVD Use: Not to be taken internally.
• Keep from Children: Keep out of the reach of children.
• Expiry Date: Do not use after the expiration date printed on the foil pouch.
• Storage: Store in the sealed pouch in a dry place at 4-30°C. Do not freeze.
• Packaging: Do not use if the pouch is torn or damaged.
• Timely Use: Do not open the foil pouch until ready to use. Use the test within 60 minutes after opening.
• Single Use: For single use only. Do not re-use any components under any circumstances.
• Biohazard: The used testing materials may contain sources of infection or other biohazards; handle with caution.
• Drug Interference: Do not take drugs containing HCG or affecting HCG test results before sampling.
• Incident Reporting: Any serious incident related to the device should be reported to the manufacturer and the competent authority.

【Frequently Asked Questions (FAQ)】
Q: How to confirm the test was run properly?
A: The appearance of a burgundy-colored band in the Control region (C) indicates proper procedure and sufficient urine volume. Absence of the C line invalidates the test; retesting is required.

Q: What about the test's precision?
A: Results for HCG standards at the same concentration were consistent, and the chromaticity was uniform.

Q: How to handle a faint positive result?
A: Very low levels of hCG (<50 mlU/mL) may be present shortly after implantation. Due to the potential for natural termination of early pregnancy, a faint positive result should be confirmed by retesting with a first morning urine specimen collected 48 hours later.

Q: Are there user requirements for near-patient testing?
A: For near-patient testing, the user shall be a normal licensed physician or nurse.

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