BD SUREPATH™ DIRECT TO SLIDE: AN EFFECTIVE ALTERNATIVE TO BD SUREPATH™ LIQUID-

BASED PAP TEST FOR RESOURCE LIMITED LABORATORIESIrfan Sagir Khan, Tan Soo Yong, Vanessa Soh Chai Hong, Goh Giap Hean

Department of Pathology, National University Hospital, Singapore

OBJECTIVE

• Cervical cancer in developing countries make up approximately 85% of the 500,000 new cases

reported each year 1.

• Many women in these countries are deprived from conventional liquid based cytology testing

(LBC) due to limited resources.

• Becton Dickinson Holdings Pte Ltd (BD) developed a modified version of the FDA approved BD

Surepath™ Liquid-based Pap Test (SP) known as BD SurePath™ Direct to Slide (DTS),

targeting the developing world, that shares similar benefits at a fraction of the cost.

• We report a comparative study on a routine group of patient samples in National University

Hospital (NUH) using both DTS & SP method to determine the efficacy of the new protocol.

In the DTS method, cell sample from the vial is layered directly into a settling chamber attached

to a slide (held in place by a small holder device) containing density reagent solution (see figure

1). The process includes cell preservation, randomization, pipetting and enrichment of

diagnostic material through centrifugation and sedimentation to create a cellular slide

preparation 2.

500 BD SurePath™ specimens were processed3. A single vial was collected per patient, which

was divided accordingly between SP (8 mL) and the remaining for DTS (2 mL) preparation. The

specimens were processed as per manufacturer protocol 2,4. The slides were then scored for

Slide Quality Characteristics of: Stain Quality, Cellular Preservation, Cellular Distribution, and

Cellularity (see table 1) 5. The diagnostic performance of DTS was assessed on 19 cases with

abnormal cervical smear results(see table 4) 6.

METHOD

Manual DTS method can produce high quality LBC slides comparable to BD Surepath Liquid Pap

Test. Laboratories with limited resources may benefit in terms of cost, space allocation and time

from incorporating this manual LBC method.

CONCLUSION

TABLE 5 Desirable findings of DTS vs

SP

Less desirable findings of DTS vs SP

• DTS is as good as SP in terms of

Cellular Preservation, Cellular

Distribution, Stain Quality and Cellularity

• No difference in diagnostic performances

of DTS and SP

• Cost effective

- Requires less equipment

- Requires less reagents

• Space saving; non-bulky equipment

• Do not require batching of specimens;

can be done even if specimen numbers

are low

• Obscuration by inflammatory cells in

highly inflamed specimen

• Unable to remove obscuring blood

especially in a bloody specimen

DTS SP

Candida

HPV

HSIL

Adenocarcinoma

Bloody smear

Inflammatory smear

REFERENCES

TABLE 2

Scoring

DTS SP

Satisfactory

(1 or 2)

Not

Satisfactory

(3)

TotalSatisfactory

(1 or 2)

Not

Satisfactory

(3)

Total

Cellular

Preservative500 0 500 500 0 500

Cellular

Distribution497 3 500 500 0 500

Stain Quality 500 0 500 500 0 500

ScoringSatisfactory

(1,2 or 3)

Not

Satisfactory

(4)

TotalSatisfactory

(1,2 or 3)

Not

Satisfactory

(4)

Total

Cellularity 492 8 500 499 1 500

ACKNOWLEDGEMENTRESULTS

TABLE 3 DTS vs SP

Concurrent % Discordant

Cellular

Preservative500 100.0% 0

Cellular

Distribution497 99.4% 3

Stain

Quality 500 100.0% 0

Cellularity 493 98.6% 7

This is a collaborative study between Becton Dickinson Holdings Pte Ltd and National University

Hospital.

TABLE 1

Cellular Preservation

Cellular

Distribution

Stain Quality Cellularity

1 = Optimal: - >90% of

cells display sharp

nuclear and cytoplasmic

features in single cells

and clusters

2 = Acceptable: 75% to

90% of cells display

sharp nuclear and

cytoplasmic features in

single cells and clusters

3 = Sub-optimal <75%

of cells display sharp

nuclear and cytoplasmic

features in single cells

and clusters

1= Optimal:

>75% even

cellular

distribution

2=Acceptable

>50% but

<75% even

cellular

distribution

3= Suboptimal:

<50% even

cellular

distribution.

1= Optimal: >90% stain

uniformity observed.

Optimal

nuclear/cytoplasmic

contrast.

2= Acceptable 75% to

90% stain uniformity

observed. Some small

areas of slightly dark or

light staining. Good

nuclear/cytoplasmic

contrast.

3= Suboptimal: <75%

stain uniformity observed.

Slide is stained

excessively light or

excessively dark. Poor

nuclear/ cytoplasmic

contrast.

1=>90K

(181+hp)

2=>40K –

90K (81 –

180 hp)

3=5K – 40K

(10 – 80 hp)

4= <5K (8 –

10 hp)

1. WHO Data Sources, IARC, Globocan, 2008.

2. BD SurePath Direct to Slide Kit Package Insert.

3. SurePath® Collection [product insert]. Franklin Lakes, NJ: Becton, Dickinson and Company; 2009.

4. BD PrepStain™ System Product Insert.

5. BD Totalys™ SlidePrep Package Insert.

6. Solomon D, Davey D, Kurman R, et al.: The 2001 Bethesda System: terminology for reporting results

of cervical cytology. JAMA 287:2114-2119, 2002.

TABLE 6: Liquid based smears prepared with DTS and SP

Figure 1

TABLE 4 Diagnostic comparison between DTS and SP on cases with abnormal cervical smear results (19/500)

DTS (review)

SP (cyto-

technologist

review)

SP (final

cytology report)

ASCUS ASCUS ASCUS

ASCUS / CIN1 ASCUS ASCUS

ASCUS, CIN1 CIN1 HPV CIN1 HPV

CIN1 HPV CIN1 HPV CIN1 HPV

HPV CIN1 ?HPV CIN1 HPV

HPV HPV ASCUS

HPV HPV HPV

CIN1 CIN1 HPV CIN1 HPV

CIN1 HPV CIN1 HPV CIN1 HPV

CIN1 CIN1 ASCH

CIN3 CIN3 CIN3

CIN2 CIN2CIN2, Suspicious of

CIN3

CIN2 CIN2 CIN2

CIN3 HPV ASCH ASCH

CIN3 CIN1 HPV ASCH

CIN3 CIN3 CIN3

Adenocarcinoma Adenocarcinoma Adenocarcinoma

Endocervical

carcinoma

AdenocarcinomaAdenocarcinoma

AGUS AGUS AGUS