Genotyping Target

• Bundibugyo virus
• Sudan virus
• Zaire virus

The RADIONE Pan-Ebola Genotyping & Marburg Multiplex Kit is an in vitro diagnostic (IVD) medical device designed for the qualitative detection of Ebola virus and Marburg virus using real-time PCR technology.

The assay detects five Ebola virus species, including Tai Forest virus, Sudan virus, Bundibugyo virus, Reston virus, and Zaire virus as a Pan-Ebola target. In addition, the assay differentiates Bundibugyo virus, Sudan virus, and Zaire virus, while simultaneously detecting Marburg virus.

The test is intended for use with human serum or plasma specimens obtained from individuals suspected of Ebola or Marburg virus infection.

The RADIONE system is a fully integrated point-of-care (POC) closed PCR platform that combines nucleic acid extraction, amplification, and result analysis within a single device, providing rapid and reliable results within approximately 65 minutes.

The Kit must be used in combination with the RADIONE instrument (KM009/KM010) and the RADIONE Universal DNA/RNA Extraction Kit (KP001).

n   Performance Summary

1.    Analytical Sensitivity (LOD)

Pan-Ebola : 800 Copies/mL

Bundibugyo : 800 Copies/mL

Sudan : 800 Copies/mL

Zaire : 800 Copies/mL

Marburg : 800 Copies/mLmL  

2.    Specificity (Cross-reactivity)

Cross-reactivity was evaluated against 21 pathogens including:

Streptococcus pneumoniae

Legionella pneumophila

Bordetella pertussis

Mycobacterium tuberculosis

Dengue virus serotype 1–4

Zika virus

Yellow Fever virus

Influenza A/B

RSV A/B

SARS‑CoV‑2

→ No cross-reactivity was observed.

3.    Interference

Bilirubin, Hemoglobin, Triglyceride
→ No interference