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LBC – Sink or Swim? Thames Valley Cytology Society Bedford 24 th June 2004. NICE Guidance. October 2003: NICE recommends that LBC is used as the primary means of processing samples in the cervical screening programme in England and Wales. NICE Guidance.

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lbc sink or swim thames valley cytology society bedford 24 th june 2004
LBC – Sink or Swim?Thames Valley Cytology SocietyBedford24th June 2004
nice guidance
NICE Guidance

October 2003:

NICE recommends that LBC is used as

the primary means of processing samples

in the cervical screening programme in

England and Wales

nice guidance1
NICE Guidance

There is currently insufficient evidence to

recommend one LBC product over

another.

The NHSCSP and SCW may wish to

consider evaluating further different

products as the method is introduced.

conventional smears
Conventional Smears

False Negative Rate of up to 55%

Sampling and interpretative errors

Borderline Rates of up to 6.4%

70% are truly negative

30% represent more severe abnormality

Inadequate Rates of 9.7%

sources of false negatives
Sources Of False Negatives

Sampling issues(70%)

  • cellsnot collected on the sampling device
  • cells collected, but not transferred to the slide

Interpretative issues(30%)

  • abnormal cells present on slide but either not seen or misinterpreted
the problem

The Problem

The Conventional Cervical Smear

The Problem

Non-randomized

portion of cells

A cervical sample

containing precancerous

cells (red)

Over 80% of

cells discarded

Sample may not

reflect patient’s

actual condition

Smear spray-fixed

and sent to lab

Missing cells,

obscuring elements

the solution

The Solution

The ThinPrep® Pap Test™

The Solution

Virtually 100% of

cells collected into

ThinPrep vial

A cervical sample

containing precancerous

cells (red)

Cells immediately

preserved and

sent to lab

Increased

opportunity to

detect early signs

of abnormality

Filtration process disperses,

randomizes cells

More representative

and clear thin layer

of cells

evidence base
Evidence Base

Clinical ValidationThinPrep® Improvement

Patients LSIL+ HSIL+ S.Q.

Split-Sample Lee et al. 6,747 65% 36% 54%

Corkill et al. 1,583 110% 54% N/A

Roberts et al. 81,754 26% 15% 91%

Direct-to-Vial Scottish Pilot 30,228 92% 84% 76%

Diaz-Rosario 56,339 72% 103% ???

Papillo et al. 8,574 52% 55% 52%

Weintraub et al. 18,247 184% 94% 93%

Bolick 10,694 181% 173% 70%

Johnson et al. 902 71% 125% 41%

Guidos/Selvaggi 9,583 267% 233% 97%

Quddus 14,216 24% 35% 28%

Hornish 30,431 N/A 83% N/A

>60 peer reviewed international publications from 4 Continents

does lbc increase sensitivity
Does LBC increase sensitivity?

Educational bias

Lab / Smear takers

Study design bias

Split sample / Direct-to-Vial

Population bias

Self-selecting / Non-screening

End point bias

Dyskaryosis as ‘surrogate’ / lack of histological confirmation

does lbc decrease inadequate rates
Does LBC decrease inadequate rates?

SurePath 5000 cells

Thinprep 40000 cells

Conventional 50000 cells?

scottish pilot results
Scottish Pilot Results

Weighted Average (total 30,228)

Conventional % ThinPrep %

Unsatisfactory 7.63 1.84

Borderline 3.98 3.67

Mild 1.10 2.12 92%↑

Moderate 0.45 0.97

Severe 0.65 1.06 84% ↑

scottish pilot conclusions
Scottish Pilot Conclusions
  • No major storage problems
  • Reduced workload for smear takers
  • 349/350 smear takers preferred ThinPrep®
  • Increased productivity in laboratories
  • Sharp reduction in the unsatisfactory rate
  • Less anxiety and discomfort for women
  • More appropriate referrals to colposcopy
  • Allows scope for further developments
  • in the screening programme
vial storage
Vial storage
  • Modular storage units available

(File-a-Vial)

150 vial capacity

  • Example:
    • 30,000 samples pa
    • 4 week cycle
    • 2,500 vials
    • 17 units
surepath
SurePath

Why I like the SurePath Liquid-Based

PAP Test

David R Bolick

RPS Sandy, Utah

surepath1
SurePath

SurePath and ThinPrep

Similarities:

Diagnostic rates

Detection rates of HPV from vial

Histology/Cytology correlation rates

surepath2
SurePath

SurePath and ThinPrep

Differences:

Inadequate rates

False negative fraction

Detection of abnormalities in clusters

surepath3
SurePath

SurePath and ThinPrep

Inadequate rates:

SurePath 0.18% 26/14419

ThinPrep 0.37% 123/33198

surepath4
SurePath

SurePath and ThinPrep

False negative fraction:

LSIL % HSIL %

SurePath 6.8 0.0

ThinPrep 14.0 16.0

SurePath screened TWICE ; ThinPrep screened ONCE

surepath5
SurePath

SurePath and ThinPrep

Abnormalities in clusters:

AGUS Endom Adenoca

SurePath 0.13 0.24 0.05

ThinPrep 0.09 0.13 0.02

slide23
LBC

LBC is on the way.

5 year conversion timescale is too long

Major retraining exercise for labs

Benefits in terms of productivity and scope for future developments

Good for smear takers and women

Issues around sensitivity / specificity / inadequate rates will be answered in long run

Expensive solution