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“HPV DNA with Pap Test is 100% negative predictor for women above 30 in
prevention of Cervical Disease” |
C o n n e c t I n g e l
e m e n t s b
e t w e e n
C e l l u l a r M
o r p h o l o g y
& M o l
e c u l a r P
a t h o l o g y
 Digene
Liquid Cytology with
H P V D N A and
Chlamydia D N A and
Gonorrhoeae D N A testing
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Atypical
Squamous Cells of Undetermined Significance (ASCUS) is ill
irreproducible diagnostic category. According to the Bethesda
2001 guidelines ASCUS diagnosis should not exceed 5% of the
total Pap smears. It must be restricted to the cases where the
criteria of classification of the intra-epithelial and
invasive lesions enough are not filled. Conventional cytology
often produces inflammatory background. High risk HPV
infections are non-inflammatory in nature.
Atypical
Glandular Cells of Undetermined Significance (AGUS) is less
frequent in comparison to ASCUS and similarly irreproducible.
Glandular cells arrangement with discrete pleomorphism
consistent with diagnosis AGUS can be seen on Digene Cytoliq
system.
 
The Low
Grade Squamous Intraepithelial Lesion (LSIL) represents
well-recognized and accepted morphologic features with
enlarged, irregular, hyperchromatic nuclei and cytoplasm
similar to that of normal superficial squamous epithelial
cells. According to the Bethesda System both CIN 1 and
koilocytotic atipia / condyloma are categorized as LSIL
reflecting their similar low incidences of progression. The
presence of koliocytes and dyskeratotic nuclei often suggest
the presence of HPV infection but may be missed in conv
cytology.
The High Grade
Squamous
Intraepithelial Lesion (HSIL) characteristic features are
squamous cells with enlarged, irregular, hyperchromatic
nuclei. The dysplastic cells, generally basophilic, can be
arranged in so called Indian line - less common in LBC than
the conventional smear. Acidophilic cells, with varied
degree of keratinization may occur. The nucleus / cytoplasm
ration is increased. Under the Bethesda System CIN 2 and CIN 3
are both categorized as HSIL.
Cellular
patterns of
isolated
cells of squamous cell carcinoma with preserved diathesis
background with different presentations of the
case on Digene Cytoliq system. Squamous
cell carcinoma
with diathesis ,
hyper cellular background
and prominent
hemorrhage may obscure conventional smear.
The adenocarcinomas present characteristic
cytological features that consist of
relatively small cells with round nuclei exhibiting
the
diverse criteria of malignancy.
Digene Cytoliq system presents a case with
glandular alterations consistent with adenocarcinoma where
solid or papillary group of cells can be seen.
Bacterial vaginosis consistent with
Gardnerella sp.
 Pseudo
hifas of Candida sp. with spores presentation.
Pseudo hifas of Candida sp. with spores
presentation.
Multinuclear cell with prominent
inclusion bodies consistent with cytopathic
effects of Herpes simplex
 Remove
the excess of mucus from the cervix using cotton or Dacron
swab.
Exfoliate cells from squamous
columnar junction (SCJ) just as
in case of Pap smear using Digene’s cervical brush. Most cervical
disease is first initiated at the SCJ.
Insert the brush in the
tube containing the UCM® solution.
Break the brush’s shaft at
the prescrored notch.
Close and agitate the tube
for approximately 30 seconds in order to homogenize the
sample.
Mix cervical specimen
collected in the UCM ® by vortexing at high speed for 15
seconds.
Pipette 200 ul of aliquot of
the UCM ® specimen and evenly dispense it on the entire
of the polycarbonate membrane of Lamigene ®. Keep the remaining 800 ul of
specimen
at 20 to
80C) for HPV or Chlamydia
or Gonorrhoeae DNA testing by hc2.
Close the Prepgene® lid,
lock the sides, and wait 10 seconds. During this step,
the imprint of cells is carried from the membrane to the glass slide.
Carefully unlock and
open the Prepgene® lid.
Remove the Lamigene®
Remove the slides containing
the cellular imprint and fix with a spray fixative, or
dip the Lamigene® strip into an appropriate container
with absolute alcohol
Remove the slides
containing cell imprints from the Lamigene®, and
perform the routine Pap staining
Discard the Lamigene®
and the Filtrogene® into the biohazard waste container.
Concurrent or Reflex hc2 HPV DNA Testing:
All women to receive HPV information as part
of their well-woman health exams. For women under 30, this
information to
include an explanation of the use of high-risk HPV
testing when a Pap test is inconclusive or inflammatory, as
7 to 17% of these may contain HSIL upon referrals. Women age
30 and older should be advised that a high-risk HPV test can
be done as part of their primary screening with or without
the Digene Liquid Pap.
Women under age 30
Concurrent or Reflex testing with The Digene
HPV Test* for ASC-US triage or ascertain colposcopic exam.
Women 30 and older
Primary adjunctive screening with The Digene
HPV Test* to detect high-risk HPV DNA types
 PREPGENE®
(Cat No. – 5100-1210B)
Manufactured using
high-resistance aluminum, it has specific fittings for the
Lamigene® on its upper part, and the Filtrogene® on its
lower part, and lateral locks that help to prepare imprint
of cells onto glass slide with consistent pressure.
DUOGENE®
(Cat No. –
5100-1250B - Duogene 432 - Box containing
36 units, corresponding to 432 tests.)
Consists of LAMIGENE and
FILTROGENE.
Lamigene®: Slide holder made o
f polypropylene, holds
12 glass
cytological slides.
Filtrogene®: Filter holder
made of high-density polystyrene, with a strip of
absorbent material, with 12 polycarbonate membranes
attached. The polycarbonate membranes are 25 mm in
diameter with 5um pores size.
This equipment works
only in combination with the Filtrogene®.
UCM® RACK ( Cat
No. – 5100-1220B)
UCM® tube rack made of
acrylic component with exact measurements matching the
DNA-CITOLIQ® SYSTEM.
UNIVERSAL COLLECTION MEDIUM -
UCM® (Cat No. –
5100-1200B)
Consists of one pre-scored
cervical brush, a transport tube containing 1 ml of UCM®
and pack insert for sample collection instruction,
supplied sealed as a sachet. Can be stored at room
temperature for upto 3 years.
The Digene HPV Test” was approved by the U.S. FDA and is also known to
laboratories and physicians as the “Hybrid Capture® 2
High-Risk HPV DNA Test” and “DNAwithPap Test.” This does not
refer to the Digene product that
tests for several types of the
virus commonly referred to as “low-risk HPV,” which are not
associated with cervical cancer.
Cancer Cytopathology, 93:93-99,
2001; Acta Cytol, 46:633-36, 2002; Acta Cytol, 41:15-23, 1997.
Diagn Cytopathol, 26:1-4, 2002; Br J Cancer, 89:1616-1623,
2001. Diag Cytopathol, 24:412-420, 2001; Arch Pathol Lab Med,
123:817-821, 1999; AHCPR, Publication number
99 – E 010,1999,
(disponível na internet:
http://hstat.nlm.nih.gov); Am J Epidemiol.141:680-689,
1995; Lancet Oncology 2:27-32, 2001. Gynecol Oncol, 86:129-33,
2002; Cancer (Cancer Cytopathol), 87:48-55, 1999; Diagn
Cytopathol, 25:334-338, 2001; Acta Cytol, 42:25-32, 1998; Br J
Cancer, 84:360-366, 2001; Obstet Gynecol, 97:781-788, 2001;
NATIONAL INSTITUTES OF HEALTH. Cervical Cancer. NIH Consensus
Statement, 14:1-38,1996; Cancer Cytopathol, 93:16-22, 2001;
Acta Cytol, 44:726-742, 2000. Curr Opin Oncol, 12:460-465,
2000. JAMA, 287:2114-9, 2002; Acta Cytol, 40:81-89, 1996;
Int J Obest
Gynecol, 61:45-50, 1998; Br
J Cancer, 86:382-388, 2002; Diagnostic Cytopathol,
22:52-59, 2000; Am J Clin Pathol, 118:399- 407, 2002;
JAMA, 287:2120-9, 2002; Mod Pathol, 14:147-151, 2001 .
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