Human papillomavirus 16/18 Genotyping PCR kit


	Chlamydia trachomatis PCR Kit Neisseria gonorrhoeae PCR kit Trichomonas vaginalis PCR kit Cytomegalovirus PCR kit Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit Human papillomavirus 16/18 Genotyping PCR kit

CE IVD

Product description

The Human papillomavirus 16/18 Genotyping PCR kit is intended for fast qualitative Real-Time PCR detection of Human papillomavirus 16 and Human papillomavirus 18 DNA in urethral swabs, endocervical and vaginal swabs, oropharyngeal swabs and rectal swabs samples.

Technical specification

Assay Principle	Real-time PCR kit for detection of Human papillomavirus 16/ Human papillomavirus 18 DNA
Test results	Qualitative
Sample material	Total DNA extracted from urethral swab specimens, endocervical and vaginal smears, oropharyngeal swabs and rectal swabs samples
Analytical Sensitivity	1000 copies of HPV 16 and 1000 copies HPV 18 genomic DNA per 1 mL
Kit content	• PCR-Mix HPV 16/HPV 18 • Taq DNA polymerase • Positive control • Negative control
Steps	• DNA Extraction • Real-time PCR • Analysis of data
Validated extraction methods	Multi DNA Extraction kit (Astra Biotech GmbH) Magnetic Plus DNA/RNA Auto Extraction kit (Astra Biotech GmbH) Magnetic DNA/RNA Auto Extraction kit (Astra Biotech GmbH)
Storage	-18…-30°C, transportation for 7 days at room temperature acceptable
Approval	CE IVD

Product formats

Form	Form S	Form T	Form F
Kit Size	• REF 87-04, 112 tests	• REF 87-05, 112 tests	• REF 87-06, 112 tests
Format Description	reaction mix under paraffin in PCR 0.1mL low profile 8-tube strips, Taq DNA polymerase supplied in a separate tube	reaction mix under paraffin in PCR 0.2mL regular profile reaction tubes, Taq DNA polymerase supplied in a separate tube	liquid reaction mix in 1.5mL tube
Validated Thermocyclers	CFX96, CFX96 Touch, QuantStudio 5 (96-well 0.1 mL Block), Light Cycler 96 (LC 96), DTprime, DTlite, SaCycler	Rotor-Gene Q, Rotor-Gene 3000/6000, QuantStudio 5 (96-well 0.2mL Block)	Rotor-Gene Q, Rotor-Gene 3000/6000, QuantStudio 5 (96-well 0.1 mL Block oder 96-well 0.2 mL Block), CFX96, CFX96 Touch, DTprime, DTlite, SaCycler, Light Cycler 96, Bio Molecular Systems MIC

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