Overview

The document describes the HBsAg Test Kit by Singclean®, which uses colloidal gold immunochromatographic assay technology for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human serum or plasma. The kit is designed for rapid, sensitive, and specific screening of Hepatitis B virus infection.

Key Specifications

• Sensitivity: 99.99%
• Specificity: 98.59%
• Sample Type: Serum or plasma
• Sample Volume: 3 drops
• Test Time: 15 minutes

Test Procedure

1. Add 3 drops of serum or plasma to the sample well on the test device.
2. Wait for 15 minutes without disturbing the device.
3. Interpret results based on the appearance of colored lines:

Result Interpretation

Quality and Manufacturing Strengths

• Manufacturing capacity: +50 units (likely batch or production scale)
• Innovation strength: +7 (indicative of technological advancement)
• Quality strength: +330 (reflecting quality control and reliability)
• Branding strength: emphasized for market recognition

Storage and Handling

The kit should be stored according to manufacturer instructions (not explicitly detailed in the text) to maintain stability and performance. Avoid exposure to extreme temperatures and moisture.

Manufacturer Information

Company: Hangzhou Singclean Medical Products Co., Ltd.
Address: No.125(E), 10th Street, Hangzhou Qiantang New Area, Zhejiang, China
Contact: Tel: 0086571-63431868-8019
Email: [email protected]
Website: www.singclean.net

Critical Notes and Recommendations

• Ensure proper sample collection and volume for accurate results.
• Strictly adhere to the 15-minute incubation time before reading results.
• Discard any test with no visible control line as invalid.
• Use the test kit as a screening tool; confirmatory testing may be required for diagnosis.

Summary

The Singclean® HBsAg Test Kit offers a rapid, highly sensitive, and specific method for detecting Hepatitis B surface antigen in serum or plasma samples. Its ease of use and quick turnaround time make it suitable for clinical and field screening applications. Proper adherence to the test procedure and interpretation guidelines is essential for reliable results.