HPV/p16 Analyte Control

Our HPV/p16 Analyte Control contains 3 cell lines that demonstrate high, medium and negative expression of high-risk human papillomavirus types 16 and 18 by in situ hybridization (ISH).

The same cell lines also demonstrate high, intermediate (heterogeneous) and negative expression of p16 by immunohistochemistry (IHC).

Ideal for use as a same slide control for HPV ISH and p16 IHC to demonstrate assay efficacy.

Cell Line 1: High HPV ISH, p16 IHC heterogeneous positive



Cell Line 2: Medium HPV ISH, p16 IHC homogeneous positive



Cell Line 3: Negative HPV ISH, negative p16 IHC



Human Papillomavirus or HPV is a group of more than 150 related viruses, over 40 of which can be transmitted through direct skin-to-skin contact during vaginal, anal and oral sex. High-risk HPV infection accounts for approximately 5% of all cancers globally. That said, most HPV infections occur without symptoms and regress within 2 years without causing cancer.

Some HPV infections, however, persist and can progress to cancer if left untreated. HPV, through expression of E6 and E7, has a negative impact by binding to the p53 and retinoblastoma tumour suppressor pathways, and as such, integration of the virus typically leads to an overexpression of p16ink4A.

Virtually all cases of cervical cancer are caused by HPV infection, with HPV 16 & 18 detected in 70%. HPV 16 is responsible for around 85% of anal cancers and HPV 16 & 18 account for approximately 50% of vaginal, vulval and penile cancers.

Within the last 20 years, the incidence of HPV-associated oropharyngeal cancer has increased, particularly among men. HPV 16 has been identified in around 50% of oropharyngeal cancers in the US.


HPV infection is determined using assays that detect viral DNA or RNA within the cell. p16 is commonly used as a surrogate marker of oncogenic HPV infection and can be demonstrated using immunohistochemistry (IHC). HPV DNA is most commonly assessed by polymerase chain reaction (PCR) and in situ hybridization (ISH).

In determining the presence of HPV DNA or p16 protein, the requirement of same slide controls are critical in the quality control of the results, particularly in demonstrating adequate sensitivity of technically challenging assays such as ISH.

The products from HistoCyte Laboratories have been developed for use as an analyte control for slide-based assays that suitably reflect the efficacy of the assays employed.

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HPV/p16 Analyte ControlDR

Full dynamic range of expression for HPV types 16 and 18

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