Human Papillomavirus (HPV) 16 & 18 Antigen Rapid Test Kit (1 pc/box)

Human Papillomavirus (HPV) 16 & 18 Antigen Rapid Test (1 pc/box)

The Human Papillomavirus (HPV) 16 & 18 Antigen Rapid Test offers a fast and reliable method to detect the two high-risk types of HPV, types 16 and 18. These viral strains are responsible for a significant proportion of cervical cancer cases worldwide, making early detection critical. This easy-to-use test provides results within a short timeframe, supporting efforts to reduce health risks.

HPV is a sexually transmitted infection with over 100 different types. Among these, types 16 and 18 are classified as high-risk due to their potential to cause cervical cancer over time. Since HPV infections are often asymptomatic, many individuals are unaware they are infected. Regular screening and preventive measures are essential to avoid serious health consequences. This product is available for professional use only.

Specifications

Product Name: Human Papillomavirus (HPV) 16 & 18 Antigen Rapid Test Kit

Sample Type: Cervical swab

Packaging: 1 test/box

Test Format: Cassette

Manufacturer: Zhejiang Biotech Co., Ltd., 178# Chuangye Rd, Qingshanhu Sub-district, Lin’an District, 311121, Hangzhou, Zhejiang, China, +86-575-83535808; Seanyuan@peptide-china.com

EC REP: CMC Medical Devices & Drugs S.L, C/Horacio Lengo No.18, 29006, Malaga, Spain, +34 951214054, info@cmcmedicaldevices.com

Expiration Date: 2026-12-15

Kit Contents

• 1 Test cassette

• 1 Extraction buffer

• 1 Extraction tube

• 1 Sample collection swab

• 1 Instructions in English

Testing Procedure

Please read the instructions carefully before performing the test. Collect the sample as described in the instructions.

• Before use, allow all reagents, devices, and samples to reach room temperature (15°C–30°C).

1. Allow the sealed pouch to warm to room temperature before opening. Remove the test cassette from the pouch and use it as soon as possible. For optimal results, perform the test within one hour after opening the pouch.

2. Wear protective equipment. Place the test cassette on a clean, flat surface.

3. Insert the sample swab into the extraction tube and rotate it against the tube walls at least ten times, pressing firmly. Remove the swab while squeezing the tube to extract as much fluid as possible. Discard the swab in a biohazard waste container.

4. Cap the extraction tube and apply 3 drops (approximately 100 μl) of the mixture onto the sample well (S) of the test cassette. Do not move the cassette until the test is complete.

5. The test begins to run, and colored lines will appear on the membrane. Read the results after 10 minutes. Results read after 10 minutes are invalid.

6. Dispose of all used materials as biohazard waste.

Interpretation of Results

HPV 16 Positive
A colored line appears in the control line region (C), and another colored line appears in the 16 test region.

HPV 18 Positive
A colored line appears in the control line region (C), and another colored line appears in the 18 test region.

HPV 16+18 Positive
A colored line appears in the control line region (C), and two additional colored lines appear in both the 16 and 18 test regions.

Negative
Only one colored line appears in the control region (C). No line appears in either the 16 or 18 test regions.

Invalid
No control line appears. Any test result that does not produce a control line within the specified reading time must be discarded. Please check the procedure and repeat the test with a new device. If the problem persists, immediately stop using the kit and contact your local distributor.

Performance

• Relative Sensitivity: 100%

• Relative Specificity: 100%

• Overall Agreement: 100%

Legal Notices

Professional Use

This product is an in vitro diagnostic (IVD) and intended exclusively for professional use by medical personnel. Use for self-testing is not permitted. The manufacturer/distributor accepts no liability for damages resulting from improper or unauthorized use.

Right of Withdrawal

In accordance with § 312g (2) No. 3 of the German Civil Code (BGB), there is no right of withdrawal for sealed goods which, for reasons of health protection or hygiene, are not suitable for return if their seal has been removed after delivery.

Disclaimer

The seller assumes no responsibility for compliance with legal regulations within the buyer’s procurement process. The seller’s responsibility is limited solely to the delivery of the ordered goods and the provision of information regarding their proper use.

Instructions