Papan
nicolaou (PAP) Stain K
Kit Catalog Numbe
C
er: KT038 Documeent #: Effectivee Date: DS‐3020‐A 02/015/15 Intended
d Use For In Vitro Diagnostic Use
e n Summarry and Explanation
The Papanicolaou (PAP) SStain Kit is designe
ed to differentiate
e between a varietty d cervical cancer. In of cells in vaginal smears ffor detection of vaaginal, uterine and
n, this procedure is valuable for staining a varietty of other bodily addition
was developed in the early 1940’s b
by secretions and cell smearss. The procedure w
Papanicolaou. George P
Blue Nuclei: B
High Kerratin Cells: Orange
e Superficial Cells: Pink Erythroccytes: Dark Pink Parabasaal Cells: Blue/Gree
en Intermed
diate Cells: Blue/G
Green Metaplaastic Cells: May con
ntain both Blue/Green and Pink Control TTissue Tissues ffixed in 10% form
malin are suitable ffor use prior to paraffin embedding. Consult references (Kiern
nan, 1981: Sheeh
han & Hrapchak, 1980) for furthe
er on specimen prepaaration. details o
1.
Cut sections, usually u
3 to 5 µm
m and pick the se
ections up on glasss slides. Bake the slidess for at least 30 minutes at approxim
2.
mately 70°C. Allow to cool. 3.
mended Positive C
Control Recomm
1.
Gynecological SSmear 2.
Any Superficial Cell Smear Reagentts Provided Volume Kit Contents Storage Modifiied Mayer’s Hematoxylin 500 mL 15‐30°C OG‐6 SSolution 500 mL 15‐30°C EA‐50 Stain Solution 500 mL 15‐30°C Storage and Handling d
printed on vial. v
If reagents arre Do not use product afterr the expiration date under conditions o
other than those sspecified here, the
ey must be verifie
ed stored u
by the user. Diluted reagents should be used promptly. Stainingg Procedure 1.
minutes. Place slide in 95% alcohol for 5 m
2.
Place slide in 70% alcohol for 5 m
minutes. 3.
2 minutes. Place slide in distilled water for 2
o completely cove
er 4.
Apply adequate Modified Mayer’s Hematoxylin to
cell smear and incubate for 5 min
nutes. Rinse slide 1 tim
me in distilled watter to remove exce
ess stain. 5.
BioSystems Diagnostic B
6616 Owens Drive Pleasanton,, CA 94588 Tel: (925) 484 3350 www. dbiossys.com 6.
7.
8.
9.
Rinse slide in tapp water for 2 minu
utes. Rinse slide in 2 cchanges of distilled
d water. Dip slide several times in 95% alco
ohol and blot excess off. Apply adequate OG‐6 Stain Solution to completelyy cover cell smearr to excess and inccubate for 2 minuttes. 10. Rinse slide gentlyy using absolute aalcohol. 11. Apply adequate EA‐50 Stain Soluttion to completelyy cover cell smearr to excess and inccubate for 3 minuttes. 12. Rinse slide gentlyy using absolute aalcohol. 13. Quickly dehydratte slide in 3 changges of absolute alccohol. mount in syntheticc resin. 14. Clear slide and m
Limitationns of the Procedurre 1.
Histological sta ining is a multiple step diagnosstic process thatt e requires speciallized training in the selection off the appropriate
reagents, tissue selections, fixation, processing, preparation of the
e slide, and interp retation of the staaining results. 2.
e Tissue staining i s dependent on tthe handling and processing of the
tissue prior to sttaining. 3.
Improper fixati on, freezing, thaawing, washing, drying, heating,, with other tissuees or fluids may
y sectioning, or contamination w
produce artifactss or false negativee results. 4.
The clinical inteerpretation of anyy positive stainingg, or its absence,, must be evaluatted within the con
ntext of clinical hisstory, morphology
y a
and other histoopathological critteria. It is the reesponsibility of a qualified patho logist to be fam
miliar with the sspecial stain and
d methods used too produce the slidee. 5.
Staining must bee performed in a certified licensed laboratory underr the supervision oof a pathologist w
who is responsible for reviewing the
e stained slides a nd assuring the aadequacy of posittive and negative
e controls. Precautio ns 1.
d Consult local an d/or state authorrities with regard to recommended
method of dispoosal. 2.
Materials of hhuman or animaal origin should be handled ass biohazardous maaterials and disposed of with proper precautions. 3.
Avoid microbial contamination o
of reagents. Con
ntamination could
d produce erroneoous results. 4.
This reagent m
may cause irritatio
on. Avoid contacct with eyes and
d mucous membraanes. 5.
If reagent contaccts these areas, rin
nse with copious aamounts of water. 6.
Do not ingest or inhale any reagen
nts. Troubleshhooting If unexpeccted staining is o bserved which caannot be explained by variations in
n laboratoryy procedures annd a problem iis suspected, co
ontact Diagnosticc BioSystem
ms Technical S upport at (9255) 484‐3350, eextension 2 orr techsuppoort@dbiosys.com. Referencees I.
Papanicolaou, G .N. Atlas of Exfoliaative Cytology, Harvard University Press, Cambridgee, 1954. o Europe
Emergo
Molensstraat 15 2513 BH, The Hague The Netherlands Tel: (311) (0) 70 345 8570