Human Papillomavirus Type 16 and 18 Diagnostic Kit PCR-Fluorescence Probing)

Human papillomavirus (HPV) Type 16 and 18 are high-risk sexually transmitted infections. As various types of HPV are known to cause cervical cancer it is important to correctly identify the specific strain of HPV infection. Traditional cancer screening methods such as PAP tests lack specificity, with approximately 75% success rate. The HPV Type 16 and 18 diagnostic test kit is designed for in vitro quantification of these pathogens with high sensitivity. Detailed clinical study has validated the high specificity, sensitivity, and reproducibility of the kit with analytical sensitivity of 1000 copies/mL in the sample. The kit contains reagents for nucleic acid extraction, realtime-PCR detection and quality control.

Catalogue #: ABI - HPV Type 16 and 18 PCR Diagnostic Kit

Principles of the test

The kit has specifically designed primers combined with composite fluorescent probes, thereby allowing utilization of realtime fluorescent PCR. The genetic sequences of HPV Types 16 and 18 can be targeted through realtime-PCR amplification. Probes are double-stranded oligonucleotides consisting of two (long and short) complementary strands bound to the reporter and quencher probes, respectively. Variation in the fluorescent signal is directly proportional to the quantity of amplified product.

Key Features

The kit contains ready-to-use reagents, offers fast real-time detection and provides excellent sensitivity and high specificity. It is also optimized for use in automated liquid handling workstations. By combining this kit with Aurora’s VERSA™ workstations, laboratories can fully automate the amplification process thereby reducing cost and operator error, while increasing efficiency.

Product Features:

• 48 tests per kit (20 µL reaction)
• Rapid detection of HPV type 16 and 18
• All necessary PCR reagents pre-mixed and ready-to-go
• Applicable for most commercially available realtime PCR instruments
• High sensitivity and high precision in determining virus types
• Standard instrument set-up parameters
• Accurate controls to confirm findings
• Colour coded reagent vials

Standard Kit Contents:

• DNA extraction reagent
• PCR detection reagent
• PCR Buffer
• Primer/Probe/dNTPs
• Thermostable DNA polymerase
• MgCl2
• Quality control reagent
• Negative control
• HPV16, 18 positive controls
• HPV16, 18 positive quantification references
• Diluent

Dynamic range of kit

Under optimal PCR conditions the kit has very high priming efficiencies of >95% and can detect between 1X108 and 1X103 copies of target template.

Handling & Storage Guidelines

Kit Storage & Shelf life - Store at -20ºC±5ºC. Avoid repeated freezing and thawing. Kit is stable until expiry date shown.

Sample Requirements & Capabilities

Genitourinary tract secretion swab sample.

Sample collection, storage and transportation

Specimens should be regarded as infectious and processed in accordance with safe laboratory procedures required by local regulations. Thoroughly clean and disinfect all work surfaces with 10% bleach solution. Supplies and equipment that have contacted specimens must be processed with high pressure wash before being discarded.

Disclaimer: The kit is for detection of the Human Papillomavirus types 16 and 18 in the genitourinary tract secretion tract samples for the laboratory diagnosis and monitoring the particular infection. The kit is for research only, and should not be used in clinical diagnosis.

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