MULTIPAP HPV DIAGNOSTIC KIT

A Step Ahead in HPV Diagnosis

Human Papillomavirus (HPV) is a widely prevalent virus worldwide that can cause various types of cancer. Early diagnosis of HPV infections is critical for disease prevention and treatment. MultiPap HPV Diagnostic Kit offers a reliable and precise solution for detecting HPV infections and identifying specific types. Developed for both screening and genotyping, the kit enables direct detection without the need for DNA isolation, ensuring a fast and efficient workflow.

Overview of the MultiPap Diagnostic Kit

The MultiPap HPV Diagnostic Kit is designed for the qualitative detection of a total of 13 high-risk HPV types using DNA obtained from vaginal and cervical swab samples. The kit is based on qPCR (real- time Polymerase Chain Reaction) technology and can work with isolated viral DNA or samples added directly to the collection fluid. This ensures fast and reliable results.

Working Principle

The MultiPap HPV Diagnostic Kit enables the amplification of viral DNA using real-time PCR (qPCR) to detect the presence and genotyping of HPV. The kit performs target amplification in two separate wells, utilizing distinct detection channels:

Well 1: Detects HPV16, HPV18, HPV45, along with an internal control to ensure assay validity.
Well 2: Detects other high-risk HPV types (HPV31, HPV33, HPV35, HPV39, HPV51, HPV52, HPV56, HPV58, HPV59, HPV68, and HPV69) using a single FAM channel.

The kit allows direct sample-to-qPCR processing by transferring swab specimens into the Multinow, eliminating the need for DNA extraction and ensuring rapid and reliable HPV screening and genotyping.

Component	QuantIty
Master MIx	1 tube
PrImer MIx-1	1 tube
PrImer MIx-2	1 tube
NegatIve Control Tube	1 tube
Positive Control Tube	1 tube

Component	QuantIty
Multinow	100 pieces
Swab Sticks	100 pieces

STORAGE CONDITIONS

qPCR Kit

Storage Temperature: -20°C

Preparation Before Use: It should be thawed by keeping it at room temperature for half an hour in a dark area.

Freeze-Thaw Cycles: Repeated freeze-thaw cycles should be avoided. If a tube needs to be frozen and thawed more than three times, aliquoting is recommended.

SAMPLE COLLECTION TUBES

Storage Temperature: At room temperature, in a place protected from sunlight.

After Sample Collection

Short-Term Storage (up to 24 hours): +4°C
Long-Term Storage (more than 24 hours): -20°C

PARAMETER	DETAILS
Targeted HPV Types	A total of 14 high-risk HPV types (HPV16, HPV18, HPV45, etc.)
Analysis Time	Less than 1 hour
Cycle Count	40 cycles
Sample Type	Vaginal and cervical swab samples
Control Types	Negative and positive control tubes with internal control
Storage Conditions	Store at -20°C; thaw at room temperature before use
Operating Temperature	Thermal cycling program adjusted according to the qPCR device
Compatibility	Compatible with standard qPCR devices

Application Protocol

To ensure accurate test results with the MultiPap HPV Diagnostic Kit, follow the steps below:

SAMPLE COLLECTION

Collect vaginal or cervical swab samples using a sterile swab stick.
Transfer the collected sample into a tube containing MultiPap sample collection fluid and mix thoroughly.

DNA PREPARATION

Samples can be processed directly from the MultiPap sample collection fluid without isolation, or an isolation step can be performed if required.
If isolation is necessary, follow the isolation procedure specified in the protocol.

REACTION MIX PREPARATION

Master Mix, Primer Mix-1, and Primer Mix-2 should be combined in the appropriate amounts according to the manufacturer’s instructions.
The prepared mixture should be carefully pipetted into the appropriate wells of the PCR plate.
Positive and negative control tubes should be added to the appropriate wells for each test batch.

DATA ANALYSIS

Data obtained from the qPCR device software should be analyzed.
Fluorescent signal data should be examined, and results should be classified as Positive, Negative, or Invalid.

Result Interpretation

RESULT TYPE	DESCRIPTION
POSITIVE RESULT	A fluorescent signal is detected due to amplification of the target HPV gene regions.
NEGATIVE RESULT	No amplification is observed in the target gene regions; however, the internal control is positive, confirming the test functioned correctly.
INVALID RESULT	Neither the target gene regions nor the internal control show amplification. The test must be repeated, as no valid result was obtained.