Name: TopPURE® HPV Pap Smear Collection Kit (HI-016) - ABT
Brand: Bộ thu và xử lý mẫu
SKU: HI-016

1. Information about Cervical Cancer and HPV Pap Smear Kit

Cervical cancer is a disease associated with abnormal proliferation of cells in the cervical epithelium (the organ between the uterus and the vagina), forming tumors in the uterus. Abnormal cervical cells exhibit characteristics such as multinucleation, increased pigmentation, and non-keratinization around the nucleus. The nucleus of abnormal cells is three times larger than that of normal cells. Changes in nuclear shape and cellular substance form the basis for cytological methods in UTCTC early screening.

Based on cell type, cervical cancer is divided into two main types: squamous cell carcinoma (SCC) and adenocarcinoma (AC). SCC occurs in the epithelial cells at the outer location of the cervix and is more common, while AC occurs in the endocrine glands of the cervix.

The main cause of cervical cancer is Human papillomavirus (HPV), a virus that induces papillomas in humans and animals. HPV (Human papillomavirus) is transmitted sexually through unprotected sexual activity. According to the World Health Organization (WHO), cervical cancer is the fourth most common cancer among women worldwide. Globocan statistics report that 185 out of 204 countries worldwide have data on cervical cancer. Among them, Vietnam ranks 91st out of 185 for incidence rate and 50th out of 185 for mortality rate globally.

The TopPURE® HPV PAP SMEAR COLLECTION KIT is a set of tools for processing and collecting vaginal cell samples from smear samples. The collected vaginal smear sample, obtained from the cervical region, is processed to remove mucus and blood in the sample medium containing ethanol buffer. The preserved cells will maintain their shape (nucleus and cytoplasm) for a minimum period of 1 month under room temperature conditions (15–25°C). Additionally, the preserved cells can be used in qualitative HPV tests through HPV DNA analysis. The UTCTC screening sample collection kit (HI-016) includes:

The sampling stick NLD8303 consists of: a handle, a sample collection tip, and a plunger. The sample collection tip is made of PE (polyethylene), while the handle and plunger are made of PP (polypropylene).
Pap smear solution is transparent, colorless, solution pH 5.5 ± 0.2.

2. Manual intructions

– Sample collection procedure:

The collection of cervical smear samples will be carried out following the procedures outlined by the Ministry of Health.

Step 1: Place the speculum in the vagina and adjust the position to ensure clear visibility of the cervix.
Step 2: Insert the gynecological sampling brush into the cervical area, press gently, and rotate the brush clockwise 5 times (Figure 1).
Step 3: Remove the brush from the vagina and gently rotate it in the Pap Smear Solution vial 5-10 times. Retain the brush head, collect the sample by detaching the head from the handle, and handle the brush appropriately.
Step 4: Close the vial lid and record patient information on the label using a pencil.

Store and transport the sample at room temperature (25°C) for up to 1 month for cytology testing (Pap test) in cervical cancer screening.

– DNA extraction procedure – HPV:

The smears stored in Pap Smear Solution can be used for qualitative HPV Real-time PCR testing:

Step 1: Aspirate 1 mL of the Pap Smear Solution-treated sample into a 1.5 mL tube. Centrifuge at 10,000 rpm for 3 minutes, collect the pellet, and discard the supernatant.
Step 2: The pellet will be used for DNA extraction following the kit’s protocol TopPURE® Genomic DNA Extraction Kit (HI-112) - silica column extraction and TopPURE® Maga Genomic DNA/RNA Extraction Kit (HI-612) - magnetic beads extraction.
Step 3: Qualify the DNA after extraction using TopSENSI® HPV qPCR Kit (SQH-103)

3. Precaution

Always wear gloves and a facemask during the procedure.
Check the packaging and product carefully before use. If the product is damaged, do not use it.
Each component in the kit is for single use only. Requirements of aseptic operations should be strictly followed. Discard immediately after use, do not reuse. Waste must be disposed in accordance with national environmental protection laws and regulations.
The kit should be stored at a temperature of 15-25°C, relative humidity not more than 80%, good ventilation.
The kit should avoid harsh condition such as high pressure, strong vibration, direct sunlight, high temperature, humidity, rain and corrosive gas or liquid during transportation.
Carefully read the instructions for use, pay attention to the expiration date of the product before use. Do not use the product after the expiration date.

For Real-time Kit: TopSENSI ® HPV 6, 11, 16, 18 & High Risk qPCR Kit (SQH-006)