The RADIONE Ebola Detection Kit is an in vitro diagnostic (IVD) medical device designed for the qualitative detection of Ebola virus, including Zaire, Sudan, Bundibugyo, Tai Forest, and Reston species, using real-time PCR technology.
The assay is intended for use with human serum or plasma specimens obtained from individuals suspected of Ebola 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 accurate 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)
Ebola virus 1000 Copies/mL
2.
Specificity
(Cross-reactivity)
Cross-reactivity
was evaluated against various viral pathogens, including Dengue, Zika, Yellow
fever, Influenza, RSV, and SARS-CoV-2, and no cross-reactivity was observed.
This demonstrates high specificity and enables accurate differentiation of
high-risk viral pathogens.
3.
Interference
Bilirubin,
Hemoglobin, Triglyceride
→ No interference
| Sample Type | Human serum or plasma |
|---|---|
| Test Type | Real-time PCR |
| Processing time | 65min |
| Operating temperature | 4°C ~ 30°C |
| Target | Ebola virus (Zaire, Sudan, Bundibugyo, Tai Forest, Reston) |
| LOD (Copies/UL) | Ebola virus 1000 Copies/mL |
The RADIONE Ebola Detection Kit is an in vitro diagnostic (IVD) medical device designed for the qualitative detection of Ebola virus, including Zaire, Sudan, Bundibugyo, Tai Forest, and Reston species, using real-time PCR technology.
The assay is intended for use with human serum or plasma specimens obtained from individuals suspected of Ebola 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 accurate 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)
Ebola virus 1000 Copies/mL
2.
Specificity
(Cross-reactivity)
Cross-reactivity
was evaluated against various viral pathogens, including Dengue, Zika, Yellow
fever, Influenza, RSV, and SARS-CoV-2, and no cross-reactivity was observed.
This demonstrates high specificity and enables accurate differentiation of
high-risk viral pathogens.
3.
Interference
Bilirubin,
Hemoglobin, Triglyceride
→ No interference
| No. | CAT NO. | PRODUCT | PACK SIZE | |
|---|---|---|---|---|
| 1 | RP017 | RADIONE Ebola Detection Kit |
|
24 Tests |
| 2 | KM009 | RADIONE |
|
|
| 3 | KM010 | RADIONE 4ch |
|
|
| 4 | KP001 | RADIONE Universal DNA/RNA extraction kit |
|
24 Tests |