Quantitative differential detection of HSV-1 and HSV-2 DNA in cervical, vaginal, penile and urethral swabs, CSF, EDTA plasma and urine specimens by real-time PCR.
Differential quantitative detection of HSV-1 and HSV-2 DNA in nucleic acid extracts from anogenital and mucocutaneous lesion swabs (cervical, vaginal, penile, urethral), cerebrospinal fluid (CSF), EDTA plasma, urine and pleural fluid specimens. Diagnosis of genital herpes, investigation of HSV-associated central nervous system disease (encephalitis, meningitis) in CSF and assessment of disseminated infection in neonates and immunosuppressed patients.
Quantitative reporting is performed in copies/mL. FAM positivity indicates HSV-1, ROX positivity indicates HSV-2; HEX/VIC is the internal control. Trend analysis (serial samples) is clinically more meaningful than a single absolute value.
| Target genes | HSV-1: US3 & US4 · HSV-2: UL36 & UL37 |
| Internal control | RPP-30 (co-amplification on HEX/VIC channel) |
| Format | 1-mix mastermix · 3-channel readout (FAM, HEX, ROX) |
| Reaction volume | 10 µL total |
| Cycle time | ~50 min |
| Standard curve | 4-point, 10³ – 10⁶ copies/µL |
| Oligo Mix | 1 × 24 µL · HSV-1 + HSV-2 primer + probe |
| Uniqplex Enzyme Mix | 1 × 120 µL |
| NTC | 1 × 1000 µL · negative control |
| Standards (4 points) | 4 × 50 µL · 10³ – 10⁶ copies/µL |
48- and 96-reaction packs are also available — see IFU §3.
The typical LoD is in the range of 50–500 copies/mL in extracted samples. The linear amplification range extends approximately 5–6 log₁₀ above the LoD. Cross-reactivity was tested against Varicella-zoster virus (closely related Alphaherpesvirinae), CMV, EBV, HHV-6/7/8, Herpes B virus, animal herpesviruses (bovine, etc.), BK virus, JC virus and Adenovirus; no reactivity was observed. No target suppression or cross-channel signal was observed between HSV-1 and HSV-2 under mixed-target conditions. Kit-specific performance values are documented in the performance evaluation report.
| Before use | −20 °C · until expiry date |
| After opening | −20 °C · 4 months (including freeze-thaw) |
| Freeze-thaw cycle | Maximum 3 |
Class C IVD device. CE marked under the transitional provisions of Regulation (EU) 2017/746. The conformity assessment process under (EU) 2017/746 (IVDR) is ongoing. TİTCK registered. For in vitro diagnostic use only — for laboratory and professional use.