HPV HR with 16 & 18 Differentiation

Test Overview:

TRUPCR® HPV HR with 16 & 18 Differentiation Kit (Single tube) is an in-vitro nucleic acid amplification assay for the detection of 14 high risk HPV along with the differentiation of HPV 16 & 18 DNA in a single tube from clinical samples using Real time PCR system.

In this kit, one tube can detect 14 HPV high risk genotypes including 16/18/31/33/35/39/45/51/52/56/58/59/66 and 68 in FAM/Green channel, HPV 16 in Texas Red/ROX/Orange channel, HPV 18 in HEX/VIC/Yellow channel and endogenous internal control in Cy5/Red channel.

An Endogenous Internal Control is incorporated into the kit to verify the quality of samples, quality of extracted DNA, amplification procedure and possible presence of inhibitors, which may cause false negative results and this design, makes this kit highly reliable.

Advantages of TRUPCR® HPV HR with 16 & 18 Differentiation Kit:

• Single tube assay for detection of 14 HR markers and detection of HPV 16 & 18
• Higher sensitivity and specificity
• Provided with endogenous internal control to exclude unreliable results
• Easy workflow & compatible with most of the real-time PCR equipment.
• All the reagents required for the test included in the kit.

TECHNICAL SPECIFICATIONS

• Sample Type – Cervical Swab Specimen, Urine Specimen, FFPE Sample
• Clinical Validation – Validated on more than 1000 clinical samples
• Target Regions – E6/E7 region by primer and probes specific for HPV 14 Genotypes (16/18/31/33/35/39/45/51/52/ 56/58/59/66 and 68)
• Reaction Volume – 30 µl in each tube
• LOD Data: 100 IU/ml
• Compatible Instruments – Applied Biosystems™ 7500 series, Applied Biosystems™ QuantStudio® 5, Rotor-Gene Q, Bio-Rad CFX96

About Human Papillomavirus:

Human Papillomaviruses (HPV) infections are among the most common sexually transmitted infections. Persistent infection with human papillomavirus (HPV) is the principal cause of cervical cancer. The presence of HPV has been implicated in more than 99% of cervical cancers worldwide, including both cervical squamous cell carcinoma and cervical adenocarcinoma. In 2018, an estimated 570,000 women were diagnosed with cervical cancer worldwide and about 311,000 deaths were reported due to this disease. HPV High Risk testing in cervical cancer screening offers a high degree of certainty.