Human Papillomavirus (HPV) 16&18 Antigen Rapid Test for Women (1 test/box)

• Every order is shipped carefully sealed, in 100% discreet packaging with a neutral sender name.

• The price includes 5% VAT.

• The product can be ordered for professional use.

Human Papillomavirus (HPV) 16&18 Antigen Rapid Test

The Human Papillomavirus (HPV) 16&18 Antigen Rapid Test offers a quick and reliable solution for the detection of two high-risk types of human papillomavirus. These viruses are responsible for a significant proportion of cervical cancer cases, so their early detection is vital. The test is easy to use and gives a result within a short time, helping to reduce health risks.

Human papillomavirus (HPV) is a sexually transmitted infection with more than 100 types. Among them, types 16 and 18 are high-risk, as in the long term they can lead to the development of cervical cancer. The infection is often asymptomatic, so many people do not even know that they are affected. Regular screening and preventive measures play a key role in avoiding serious consequences. The product can be ordered for professional use.

Human Papillomavirus (HPV) 16&18 Antigen Rapid Test specification

Product name: Human Papillomavirus (HPV) 16&18 Antigen Rapid Test Kit
Sample: cervical swab
Packaging: 1 pc/box
Format: Cassette test
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
Expiry date: 01/03/2028

Contents of the Human Papillomavirus (HPV) 16&18 Antigen Rapid Test Kit

• 1 test cassette
• 1 extraction solution
• 1 extraction tube
• 1 sampling swab
• 1 instructions for use in Hungarian

Test procedure

Read the Instructions for Use carefully before performing the test! Collect the sample as described in the instructions for use.

Before use, allow the devices, reagents, and samples and/or controls to reach room temperature (15°C–30°C).

After sample collection:

1. Before opening, allow the pouch to come to room temperature. Remove the test cassette from the sealed pouch and use it as soon as possible. The best results are obtained if the assay is performed within one hour. For best results, the assay should be performed within one hour of opening!

2. Wear protective equipment. Remove the test from the sealed pouch and place it on a clean, flat surface. For best results, the assay should be performed within one hour.

3. Place the sample-soaked swab into the tube and mix the solution by rotating the swab while pressing it firmly against the side of the tube at least ten times (while immersed). The best results are obtained when the sample is mixed thoroughly in the solution. When removing the sampling swab, squeeze as much liquid as possible out of the swab by pinching the side of the flexible extraction tube. Discard the used sampling swab into a biohazard waste bag.

4. Put the cap on the tube, then add 3 drops (100 μl) of the mixture to the sample area (S) of the test cassette. Do not move the cassette until the test is complete and ready to be read.

5. As the test begins to work, the color migrates across the membrane. Wait for the colored band(s) to appear. The result should be read at 10 minutes. The result is invalid after 10 minutes.

6. Place all tested devices (cassette, buffer, etc.) into a biohazard waste bag.

Interpretation of results

HPV 16 Positive

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

HPV 18 Positive

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

HPV 16+18 Positive

A colored band appears in the control line region (C), and two other colored bands appear in the 16 and 18 test regions.

Negative

Only one colored band appears, in the control region (C). No band appears in either the 16 or the 18 test region.

Invalid

The control band does not appear. Test results that have not produced a control band within the specified reading time must be discarded. Please review the procedure and repeat it with a new test. If the problem persists, stop using the kit immediately and contact your local distributor.

Performance of the Human Papillomavirus (HPV) 16&18 Antigen Rapid Test

• Relative sensitivity: 100%
• Relative specificity: 100%
• Overall agreement: 100%

The test may only be used by competent professional staff and healthcare professionals! Carbon Web Kft. accepts no liability for use for self-testing purposes.

ATTENTION!
Pursuant to Government Decree No. 45/2014 (II. 26.), for health protection or hygiene reasons this product cannot be returned after delivery; therefore the 14-day right of return does not apply to this product. Section 29 (1) The consumer may not exercise the right set out in Section 20 (the consumer’s right of withdrawal) e) in respect of a product in sealed packaging which, for health protection or hygiene reasons, cannot be returned after it has been opened following delivery.

Carbon Web Kft. is not responsible for fulfilling the legal obligations related to the Buyer’s procurement procedure, as this falls within the Buyer’s competence; its responsibility is limited solely to information on intended use and to the goods delivered.