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CINTEC PLUS CYTOLOGY

Synonym(s):

​CINtec PLUS Cytology, Immunocytochemistry

Description

CINtec® PLUS Cytology Kit is an immunocytochemistry assay for simultaneous qualitative detection of p16INK4a and Ki-67 proteins in cervical cytology preparations.

Indications

​The test indicates oncologically transforming HPV infections and is indicated to be used as an aid in the identification of women with high-grade cervical intraepithelial lesions in a screening population, and in the sub-groups of patients with a Pap cytology result of ASC-US (atypical squamous cells of undetermined significance) or LSIL (low-grade squamous intraepithelial lesion), or in patient with positive high-risk HPV performed.

Specimen Required

​​1. Cytologic sample collected in PreservCyt® Solution (Hologic Inc.) - see site specific instruction on specimen collection and handling of (A) Gynaecological Cytology for details. (Do not use lubricant as it will affect the quality of the smear prepared).

A cytology gynaecological CPOE request that is properly filled up - see the CPOE request for details. 

OR

2. Archived specimen from Molecular Laboratory that is no more than 6 weeks from collection date may be used.

Alert Cytology lab (6576 7587) of the additional request. Put up a new cytology gynaecological CPOE request that is properly filled up and send the CPOE label to Cytology Lab.

Storage and Transport

Method

​The CINtec® PLUS Cytology Kit is optimized for use on VENTANA BenchMark GX, XT and ULTRA automated slide strainers. ThinPrep® (Hologic Inc,) slides are prepared on a Thinprep® 2000 processor (Hologic Inc.) according to manufacturers. The p16INK4a and Ki-67 proteins in the cytological specimens are detected using a ready-to-use cocktail of primary monoclonal antibodies which contains a monoclonal mouse antibody directed against human p16INK4a protein (clone E6H4™) and a primary recombinant rabbit antibody against human Ki-67 protein (clone 274-11 AC3).

The staining results are evaluated by light microscopy inspection and are to be interpreted in conjunction with patient’s clinical history and additional diagnostic tests that have been performed.

Test Results

Reference Interval / Value

Turnaround Time

7 working days

Day(s) Test Set up

​Tuesday and Thursday

Remarks

Change History Notes

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