MPXV PCR Monkeypox Virus Freeze-Dried Multiplex Real-Time PCR Detection

Monkeypox Virus (MPXV) Real-Time PCR Detection Kit

1. Intended Use

The Monkeypox Virus PCR Kit is an in vitro diagnostic (IVD) assay designed for the qualitative detection of Monkeypox virus (MPXV) DNA in human clinical specimens (e.g., lesion swabs, vesicular fluid, crusts, or blood) using real-time polymerase chain reaction (qPCR).

Technical Parameters:

2. Features

• High Specificity: Targets conserved regions of the MPXV genome (e.g., F3L, N3R, or B6R genes) with no cross-reactivity to other orthopoxviruses (e.g., smallpox, vaccinia) or herpesviruses.

• High Sensitivity: Detection limit as low as 10–50 copies/mL.

• Rapid Turnaround: Results in 60–90 minutes (varies by instrument).

• Multiplex Options: Some kits include internal controls (e.g., human RNase P gene) to validate sample integrity.

• CE-IVD/FDA-EUA Approved: Complies with international regulatory standards (check manufacturer claims).

3. Kit Components

• PCR Master Mix: Pre-mixed reagents (dNTPs, Taq polymerase, buffers).

• Primers/Probes: Specific to MPXV DNA.

• Positive/Negative Controls: For assay validation.

• Extraction Reagents (if included): For automated/manual DNA extraction.

4. Specimen Collection & Storage

• Preferred Samples: Lesion swabs (dry or in viral transport medium), skin crusts.

• Storage:

  • Short-term: 2–8°C (≤72 hours).

  • Long-term: ≤–70°C.

5. Workflow

1. Nucleic Acid Extraction: Isolate DNA from specimens (manual/automated methods).

2. PCR Setup: Mix extracted DNA with master mix and primers/probes.

3. Amplification & Detection: Run on qPCR instrument (e.g., Bio-Rad CFX, Roche LightCycler).

4. Result Interpretation:

   • Positive: Cycle threshold (Ct) ≤40 with characteristic amplification curve.

   • Negative: No amplification (Ct >40 or absent).

6. Performance Data

• Sensitivity: >95% (vs. sequencing gold standard).

• Specificity: >99% (no cross-reactivity with related viruses).

7. Ordering Information

• Catalog Number: [Manufacturer-specific, e.g., MPX-100].

• Pack Size: 24/96 tests per kit.

• Storage Conditions: –20°C (avoid freeze-thaw cycles).

8. Manufacturer & Compliance

• Brand: [e.g., Thermo Fisher, Roche, DaAn Gene].

• Regulatory Status: CE-IVD (EU), FDA Emergency Use Authorization (USA), or local approvals.