chapter
34
Automation in Cervical Cytology
David C Wilbur and Marluce Bibbo
Contents
In tro d u c tio n
S ta in U s e in A u t o m a t e d S y s t e m s
H isto ric a l A tte m p ts at A u to m a tio n
T r a in in g R e q u ire d f o r I n it ia t io n o f A u t o m a te d M e t h o d s
L a b o r a to t
y
W o r k f lo w Is s u e s
T h e R a tio n a le fo r A u to m a tio n
C o s t-e ffe c tiv e n e s s o f L iq u id -b a s e d P re p a ra tio n a n d A u to m a te d
C y t o lo g y A u to m a tio n : A c c u r a c y a n d P ro d u c tiv ity
S c r e e n in g D e v ic e s
C u rre n tly A v a ila b le A u to m a tio n P la tfo rm s
C o n c lu d in g R e m a rk s
L iq u id -b a s e d p re p a r a tio n
A u t o m a te d S c r e e n in g D e v ic e s
L a b o ra to ry P ro ce ss Issu e s A ss o c ia te d w ith th e U se o f A u to m a te d
D e v ic e s
R e p o r tin g Is s u e s
Iss u e s w it h S p e c im e n s t h a t C a n n o t B e S u c c e s s fu lly p ro c e s s e d
Introduction
Historical Attempts at Automation
In the chapter o n cytology a u to m a tio n in the second e d itio n o f
C o m p re h e n s iv e C y to p a th o lo g y ,
p ublished in 1997, Bartels, Bibbo,
and W ie d p rovide a prescient description o f the challenges and
strategies fo r the developm ent o f autom ated cervical cytology
screening devices. In fact, w ritin g a decade later, it is possible
to fo llo w th e ir predictions d irectly to the instrum ents th a t are
curren tly in clinical use. A th o ro u g h reading o f th a t discussion
w ill give th e interested observer a background o f the qualities
and features th a t m ust be in h e re n t in such devices in ord er to
provide the accuracy necessary to the process, and also the p ro-
gression o f developm ent necessary to m eet the requirem ents
o f reg ulatory agencies. A t present, th is process has gone fro m
a h a lf century o f developm ental w o rk to fru itio n in the fo rm o f
p rim a ry screening instrum ents in clinical cytology laboratories.
A lo n g the way, enorm ous am ounts o f tim e and energy have been
spent o n developm ent o f specim en preparation m ethod s and
in stru m e n ta tio n , optical systems, com puters, and a lg o rith m ic
and o th e r types o f inform ation-p rocessing systems. T his fo llo w s
o n the o rig in a l w o rk necessary to the process, th a t being the
m o rp h o m e tric m easurem ents o f cells, b o th n o rm a l and ab nor-
m al, th a t have provided the inp uts necessary fo r these processes
and devices. T his discussion w ill h ig h lig h t the histo ric al features
th a t have influenced the processes and the devices c urrently in
use, provide a practical presentation o f th e ir m ode o f op eration,
and detail th e ir perform ance characteristics as presented in the
m edical literature. A closing discussion w ill speculate o n w h a t
m ay be the next step in the e vo lu tio n o f th is discipline.
As one o f the last hig h-volum e, m a n u a lly p erform ed procedures
in the laboratory, cervical cytology has always been a target fo r
a uto m a tion . A b o u t a h alf-ce ntury o f tim e and energy has been
devoted to th is task, beg inning w ith developm ental w o rk nec-
essary to define w h a t constituted m orp holog ically, and m ore
im p o rta n tly m orp h om etrica lly, the im p o rta n t, q u alitative and
q u an titative features o f cells— benign, reactive, and neoplastic—
obtained in a cervical cytology specimen.
In the days o f Caspersson's q uantitative analysis o f nucleic acid
and proteins by m icrospectrophotom etry, it was estim ated th a t
gathering in fo rm a tio n ab out one cell required a week's w ork.
D etailed in fo rm a tio n on the relative o r absolute n um b er o f
m easuring p oints per cell became available fro m the sop h isti-
cated m achines o f Caspersson,1
H yden and Larsson,2 Deeley,3
M o n tg o m e ry,4 T h o rn b u rg ,5 and T o lle s.6 However, despite this
im p o rta n t and p ioneering w o rk, the p o ten tial fo r th is detailed
in fo rm a tio n rem ained largely unrecognized.
It was the widespread acceptance o f the diagnostic capa-
b ilitie s o f cytology th a t eventually generated demands fo r the
a u to m a tio n o f th is h ig h ly tim e -co nsu m ing and tedious m an -
ual procedure. B oth cytochem ical and c ytom orp holog ic cri-
teria were used in the cytoanalyzer project o f the US N a tio n a l
Cancer In s titu te in an early attem p t to develop an autom ated
process.7-10 It was discontinued because o f its in a b ility to be able
to resolve the com p lexity o f ro u tin e ly prepared conventional
cytology specimens due to cell overlap and obscuring factors.
In a d d itio n, the robustness o f the softw are was inadequate fo r
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