Sexually transmitted disease test kit S3017E

STDdiagnosticgynecology

Brief
This HPV (Type 6 and 11) DNA Fluorescence Diagnostic Kit S3017E (PCR‑Fluorescence Probing) is an in vitro nucleic acid amplification test for detection of low‑risk HPV (type 6/11) DNA in reproductive tract secretions. It is intended to assist clinical diagnosis of HPV (type 6/11) infection and to support assessment of patients with clinically suspected genital warts.

Parameters

• Specimen Type: reproductive tract secretions
• Technical Platform: One‑tube fast release technology; Advanced magnetic beads technology
• Detection types: type 6, 11
• Internal Control: β–globin gene
• PCR Instrument: ABI7500; QuantStudio 5; Stratagene Mx3000P; MA‑6000; SLAN‑96P; LightCycler® 480 II; iPonatic S‑Q31A&B; S‑Q36A
• Amplification Time: 70 min
• Sensitivity: 400 copies/mL
• Spec.: 48T, 12‑P
• Qualification: CE

Technical specifications

• Intended use: in vitro qualitative detection of HPV types 6 and 11 DNA in reproductive tract secretions to aid diagnosis of infection and clinical evaluation of genital warts
• Assay principle: real‑time PCR with fluorescence probing for specific identification of target genotypes
• Sample handling: compatible with standard collection of reproductive tract secretions; follow local laboratory biosafety procedures
• Compatibility: validated on listed PCR instruments; verify settings and calibration per instrument manual
• Throughput and packaging: available in 48T and 12‑P formats to suit different laboratory workloads
• Regulatory status: CE marked