GMB INTERNATIONAL

TECHNOLOGY

PAP Smear Processing

Sampling
Smearing
Staining
Cover slipping

PAP vs LBC

PAP Smear

Liquid-based Cytology (LBC)

Cervical Cancer Progression

Negative
Atypical
Positive 1,2
Positive 3

Filtration Mechanism

Solution & Membrane

User Parameters

  1st
Suction
Time		 2nd
Suction
Time		 3rd
Suction
Time		 Smear
Pressure
(10 Levels)		 Smear
Time		 Smear
Speed
(10 Levels)		 Suction
Pressure
(20 Levels)
GYN 1 2 3 7 1.0 5 20
Body Fluid 3 2 2 4 1.0 5 16
Urine 5 2 1 3 1.0 5 17
FNA 3 2 2 4 1.0 5 17
Sputum 3 2 2 4 1.0 5 18

Smearing
Cellularity

  • Obtain 10 images at arbitrary points on 5 individual slides
  • Calculate the Number of cells in each image using "Cell Profiler" S/W
  • For 5 slides, Minimum Cellularity is 75%
Sample Gyn-1 Gyn-2 Gyn-3 Urine Body Fluid
Cell Image
Acerage 302.50 500.10 242.80 36.50 35.40
Cellulatiry 87.10% 87.22% 75.29% 87.20% 75.47%

Clinical
Test Reports

Diagnosis by GmbPrep and A company (US)

Diagnosis GmbPrep A company (US)
NIL 262 (87.9) 261 (87.6)
ASC-US 29 (9.7) 28 (9.4)
ASC-H 1 (0.3) 1 (0.3)
LSIL 5 (1.7) 6 (2.0)
HSIL 1 (0.3) 2 (0.7)
Carcinoma 0 (0.0) 0 (0.0)
Total 298 (100) 298 (100)

Values are presented as number(%)
NIL, negative for intra-epithelial lesion; ASC-US, atypical squamous cells of undetermined significance;
LSIL, low-grade squamous intraepithelial lesions ; ASC-H, atypical squamous
cells-cannot exclude high-grade lesion;HSIL, high-grade squamous intraepithelial lesions;

Diagnosis Agreement GmbPrep vs A company (US)

Diagnosis Diagnosis by A company (US)
NIL ASC-US ASC-H LSIL HSIL Carcinoma Total
NIL 246 15 0 0 0 0 261
ASC-US 16 11 0 1 0 0 28
ASC-H 0 0 1 0 0 0 1
LSIL 0 2 0 4 0 0 6
HSIL 0 1 0 0 1 0 2
Carcinoma 0 0 0 0 0 0 0

Values are presented as number(%)
NIL, negative for intra-epithelial lesion; ASC-US, atypical squamous cells of undetermined significance;
LSIL, low-grade squamous intraepithelial lesions ; ASC-H, atypical squamous
cells-cannot exclude high-grade lesion;HSIL, high-grade squamous intraepithelial lesions;

  • The test results of two systems are almost identical.
  • The slides made with GmbPrep have a relatively clean background, but many useful cells that help diagnosis have showed very similar slide quality between GmbPrep and A company (US).
  • The clinical results of GmbPrep and A company (US) were similar, especially in LSIL and HSIL. In A company (US), a problem was observed as meaningful cells were not smeared onto slide properly because the filter was not sticking sufficiently to the sample when dispensing the sample.
  • A company (US) has been observed to have a general phenomenon that cell nuclear membrane is a little shrunken, but GmbPrep has no such phenomenon.
  • In addition, A company (US) was observed to have a lot of cells attached to outside the center of circle on slide, but the distribution of cells in GmbPrep showed a uniform pattern throughout the circle.
  • In conclusion, GmbPrep showed similar performance characteristics as A company (US) in diagnosis