ABT® CERVICAL CYTOLOGY CENTRIFUGE I KIT (LBC-013)

Information about Cervical Cancer and ABT ® Cervical Cytology Centrifuge I Kit

Cervical cancer is a disease associated with the abnormal proliferation of epithelial cells in the cervix (the organ connecting the uterus and the vagina), forming tumors in the uterus. Abnormal cervical cells exhibit the following characteristics: multinucleation, hyperchromasia, and cytoplasmic vacuolization around the nucleus. The nuclei of abnormal cells are three times larger than those of normal cells. Changes in nuclear and cytoplasmic morphology form the basis for cytological methods in early screening for cervical cancer. Based on the cell type, cervical cancer is classified into two main types: squamous cell carcinoma (SCC) and adenocarcinoma (AC). SCC occurs in the epithelial cells at the outer cervix and is more common, while AC occurs in the glandular cells of the cervix.

The main cause of cervical cancer is the Human papillomavirus (HPV), a virus that causes papillomas in humans and animals. HPV spreads through genital contact via unsafe sexual activities. According to the World Health Organization (WHO), cervical cancer is the fourth most common cancer among women worldwide. In 2020, there were approximately 604,000 new cases and 342,000 deaths from cervical cancer. About 90% of new cases and deaths occurred in low- and middle-income countries. According to Globocan statistics, 185 out of 204 countries worldwide report on the situation of cervical cancer. Vietnam ranks 91st out of 185 in terms of new incidence rate and 50th out of 185 in terms of mortality rate globally. This shows a significant increase compared to 2018, where the new incidence rate was 99th out of 185, and the mortality rate was 56th out of 185.

ABT® Cervical Cytology Centrifuge I Kit is optimized for the collection, processing, and deposition of cells onto glass slides utilizing density-gradient liquid-based cytology (LBC) technology on the Cyto-centrifuge Smear Processor (LTS-YJ1000). Furthermore, it preserves and stabilizes gynecological specimens at temperatures ranging from 15–30°C for up to one month, facilitating cytological examinations (liquid-based Pap tests) for cervical cancer screening. Additionally, the smear samples collected and preserved using this kit can be processed for downstream HPV-DNA testing.

The ABT ® Cervical Cytology Centrifuge I Kit (LBC-013) consists of the following components:

- Sample collection swab:

• Material: PE + PP
• Sample collection head diameter: 19.5 ± 2 mm
• Total length: 202±10 mm

- Microscope slide:

• Material: Glass

• Length: 75±0.5 mm, Width:25±0.5mm, Thickness: 1.5±0.5mm

- Cyto-centrifuge Chambers:

• Material: PE + PP
• Height: 35.5mm, Diameter: 13mm

– ABT® Cell Preservative Solution:

• Homogeneous, transparent, colorless, slightly viscous, sediment-free liquid.
• pH 5.5±0.2
• Sample storage duration: Within one month from the collection date.

– ABT ® Density Solution:

• A homogeneous, transparent, colorless liquid with slight viscosity, free from impurities and sediment. It has the characteristic odor of the product without any unusual smells.
• Processing capability: Processes and removes mucus, blood, and inflammatory cells in gynecological smear samples (GYN) and collects target epithelial cells.

– Plastic pipettes:

Manual instruction ABT ® Cervical Cytology Centrifuge I Kit

- Prepare the kit components for a single assay: 1 bottle of ABT® Cell Preservative Solution (GYN) (10 mL), 1 collection swab, 1 cyto-centrifuge chamber, 1 electrostatic glass slide, and 1 plastic pipette.
- Required materials not provided: Plastic tray, vaginal speculum.
- Processing reagent: ABT ® Density Solution

1. Sample preparation:

Cervical smear samples will be collected according to the Ministry of Health's procedure (Appendix 1, Decision 3877/QD-BYT 2019):

• Step 1: Insert a speculum into the vagina and adjust its position to ensure a clear view of the cervix.
• Step 2: Insert the sampling brush into the cervix, press gently, and rotate the brush clockwise 5 times (Figure 1).
• Step 3: Remove the sampling brush from the vagina and place it into the ABT® Cell Preservative Solution vial, gently rotating it 5 to 10 times. The head of the sampling brush is retained by detaching it from the handle, and the handle is disposed of properly.
• Step 4: Close the vial and record the patient's information on the label with a pencil.

Maintain specimens at room temperature (15–30^oC) for up to 01 month for liquid-based Pap smear cytological screening. Specimens collected and preserved using this kit are also compatible with downstream HPV-DNA molecular testing.

Figure 1 Position for placing the cervical smear sampling brush.

2. Processing and smearing slides

- Label the patient information on the frosted end of the electrostatic glass slide using a pencil, and on the cyto-centrifuge chamber using a marker.

- Perform the automated processing and smearing using the Cyto-centrifuge Smear Processor (LTS-YJ1000) according to the following protocol:

• • Step 1:Mount the glass slide and the cyto-centrifuge chamber onto the plastic tray.
  • Step 2: Pipette 1 mL ABT® Density Solution onto the surface of the cyto-centrifuge chamber.
  • Step 3: Homogenize the specimen by vortexing the ABT® Cell Preservative Solution bottle containing the cervical smear for approximately 15 seconds.
  • Step 4: Pipette 1 mL of the thoroughly mixed specimen and slowly overlay it onto the ABT® Density Solution, ensuring the two solutions form distinct, separate layers.
  • Step 5: Centrifuge at 1300 rpm for 3 minutes to sediment and smear the target cells onto the glass slide.
  • Step 6: Aspirate and discard the supernatant, then retrieve the prepared slide.

- After smearing, fix the glass slide in 96% ethanol for 15 minutes and stain with PAP according to the procedure of the ABT ® Papanicolaou Staining Kit (DD-083; DD-084).

- Observe and analyze the results under a microscope.

Note: 

- Always wear gloves and a mask during the procedure.

– Shake the ABT® Cell Preservative Solution well before opening the cap for use.

– The appropriate sample collection time is within 2 days before or after menstruation.

– Contraindicated in pregnant women.

– Waste must be disposed of according to national environmental protection laws and regulations.

3. Recommendations:

For use exclusively with the Cyto-centrifuge Smear Processor (LTS-YJ1000).

Read more: ABT® CERVICAL CYTOLOGY MANUAL KIT (DD-102)