Truenat® HPV-HR

Description

Intended Use

Semiquantitative detection of high risk Human Papillomavirus (HPV) types 16, 18, 31 and 45 in female cervical specimens collected by a clinician. It aids in the differential diagnosis of symptomatic or asymptomatic infection with high risk HPV types 16, 31 and 18, 45

Key Features

– Assay based on Taqman chemistry

– High primer sensitivity and specificity

– Micro chip based real-time PCR assay

– Minimal sample requirement @ 6µL

– Smart chip with lot specific data for quantitation of results

– Chip re-use lock

– Reaction port with contamination/evaporation resistant design

Test Duration

1 Hour

Storage/Stability

2 – 30°C for two years

Contents of the Kit

1. Individually sealed pouches, each containing
2. Truenat HPV-HR micro PCR chip
3. Microtube with freeze dried PCR reagents
4. DNase & RNase free pipette tip
5. Desiccant pouch

1. Package Insert