Packing Specification

50 tests/kit

 

Intended use

The kit is used for qualitative fluorescence-based PCR detection of nucleic acid fragments specific to 14 human papillomavirus (HPV) types (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) in cervical exfoliated cells in women, as well as for HPV 16/18 genotyping to help diagnose and treat HPV infection.

The test using the kit cannot be used alone or prior to the application of cervical cytology, i.e., it is not recommended to use the test alone for cervical cancer screening in people of any age. The test cannot replace cervical cytology and cannot be used alone as a basis for patient management. Since no corresponding clinical trials of the kit have been conducted, it shall not be used for clinical purposes related to cervical cancer screening.

 

Main components

 

Reagents required but not provided

Nucleic Acid Extraction or Purification Kit（Magnetic Beads Method）(HWTS-3001) , Nucleic Acid Extraction or Purification Kit（Magnetic Beads Method）-Pre-packed 48 (HWTS-3004-48) and Nucleic Acid Extraction or Purification Kit（Magnetic Beads Method）-Pre-packed 32 (HWTS-3004-32)from Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. Viral Genomic DNA/RNA Extraction Kit (DP315) manufactured by Tiangen Biotech (Beijing) Co., Ltd., QIAamp DNA Mini Kit (Cat. no.51304) manufactured by QIAGEN.

 

Consumables requires but not provided: 

1.5 mL RNase- and DNase-free centrifuge tubes, RNase- and DNase-free tips, fluorescence-based qPCR tubes, benchtop centrifuge, benchtop vortex mixer.

 

Specimen collection

Before sampling, use a cotton swab to gently wipe the excessive secretions from the cervix. Discard the used swab. Allow a new cotton swab infiltrated with cell preservation solution or a brush for sampling cervical exfoliated cells to adhere closely to the cervical mucosa, and rotate it clockwise for 3-5 times to obtain cervical exfoliated cells. Slowly take out the cotton swab or brush and put it in 1 mL sterile saline. After fully rinsing it, squeeze the cotton swab or brush against the tube wall to dry it and then discard it. Tighten the tube cap and mark the name (or number) of the specimen on the tube.

 

Applicable instruments

SLAN®-96P Real-Time PCR Systems

Applied Biosystems 7500 Real-Time PCR Systems

QuantStudio™ 5 Real-Time PCR Systems

LightCycler® 480 Real-Time PCR system

LineGene 9600 Plus Real-Time PCR Detection System（FQD-96A）

MA-6000 Real-Time Quantitative Thermal Cycler