ABT® CERVICAL AUTO-CYTOLOGY KIT (LBC-015)

Information about Cervical Cancer and ABT ® Cervical Auto-Cytology 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 Auto-Cytology Kit is optimized for collecting, processing, and smearing cells onto glass slides using vacuum-suction LBC technology combined with a single membrane filter. Additionally, it preserves and stabilizes gynecological cells at 15–30°C for up to 1 month, serving cytological analysis (Liquid-Based Pap smear) for cervical cancer screening.

The ABT ® Cervical Auto-Cytology Kit (LBC-015) including:

- 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

- Coarse Filter Cylinder:

• Material: PE + PP.
• Height: 54 mm.
• Diameter: 24.5 mm

- Micro Filter Cylinder:

• Material: PE + PP.
• Height: 55 mm.
• Diameter: 30 mm

– 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.

Manual instruction ABT ® Cervical Auto-Cytology Kit

- Kit preparation for 1 test: 1 vial of ABT ® Cell Preservative Solution (GYN) (20 mL), 1 sampling swab, 1 micro filter cylinder, 1 coarse filter cylinder, 1 electrostatic slide.
- Other materials required (not provided): Vaginal speculum.

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.

Store and transport specimens at room temperature 15 – 30°C within 01 month for cervical cancer screening cytology (Liquid-Based Pap smear).

Figure 1 Position for placing the cervical smear sampling brush.

2. Processing and smearing slides

- Write patient information on the frosted end of the electrostatic slide using a pencil.
- Perform the slide smear using vacuum-suction LBC Systems according to the following procedure:

• • Step 1: Insert the electrostatic slide and micro filter cylinder into their designated positions on the equipment.
  • Step 2: Vortex-mix the smear fluid suspension and ABT ® Cell Preservative Solution for 15 seconds.
  • Step 3: Remove the swab shaft and insert the coarse filter cylinder directly into the vial.
  • Step 4: Select the GYN mode on the system and smear the cells onto the glass slide according to the system's program.

- 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 masks 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 treated in accordance with National Environmental Protection Laws and Regulations.

3. Recommendations:

Some LBC systems compatible with this kit include: ThinPrep 2000 Processor, PathTezt® 2000 LBC Processor, Liquid-Based Cytology Smear Processor (LTS-YJ2000), and CytoPath® Processor.

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