Bundibugyo ebolavirus is not an edge case. GoldN covers it.
GoldN™ Easy to Use Ebola Rapid Antigen Test was developed to detect five Ebolavirus strains from a 15 µL fingerstick blood sample in 15 minutes, with no observed Marburg VP40 cross-reactivity in specificity testing.
Five Ebolavirus strains. Bundibugyo highlighted.
GoldN™ Easy to Use Ebola Rapid Antigen Test detects ZEBOV, SEBOV, BEBOV, TAFV, and RESTV. Specificity testing showed no observed Marburg VP40 cross-reactivity.
Bundibugyo ebolavirus
BEBOV is included in the coverage set, giving GoldN™ Easy to Use Ebola Rapid Antigen Test broader listed Ebolavirus inclusivity than comparator entries with Zaire-only coverage.
Included in the five-strain Ebola coverage set.
Included in comparator and assay coverage data.
Included for multi-species Ebolavirus response.
Included in the five-strain coverage set.
Included in the five-strain coverage set.
Built around a 15 µL fingerstick blood sample.
GoldN™ Easy to Use Ebola Rapid Antigen Test keeps the first-use workflow simple while preparing for GoldN Reader-enabled track, trace, and semi-quantitative result capture.
Collect fingerstick blood
Use a 15 µL fingerstick blood sample for the Ebola antigen test workflow.
Apply sample and buffer
Add the blood sample and assay buffer to the cassette according to instructions.
Wait 15 minutes
The lateral-flow strip develops a control line and test line pattern.
Read the result
The test can be read visually. The next frontier is the GoldN Reader for track, trace, and semi-quantitative fluorescence readout.
Five-strain coverage. Low sample volume. 15-minute result.
GoldN™ Easy to Use Ebola Rapid Antigen Test combines five-strain Ebola coverage, a 15 µL fingerstick blood sample, 15-minute results, and a GoldN Reader path for semi-quantitative fluorescence readout.
Bundibugyo included
BEBOV coverage is built into the five-strain Ebola antigen claim set.
No observed Marburg VP40 cross-reactivity
Specificity testing showed Ebola VP40 reactivity without observed Marburg VP40 reactivity.
Lower analytical detection limit
0.1 ng/mL or 0.0015 ng/test analytical sensitivity in feasibility data.
Reader-ready next step
GoldN Reader adds track, trace, and semi-quantitative result capture for clinical validation programs.
Five-strain coverage and lower analytical LoD in the comparator set.
Lower analytical detection limit indicates higher analytical sensitivity. Comparator values support procurement review and clinical-validation discussions.
| Metric | GoldN™ Easy to Use Ebola Rapid Antigen Test | Competitor 1 | Competitor 2 | Competitor 3 |
|---|---|---|---|---|
| Ebolavirus coverage | ZEBOV, SEBOV, BEBOV, TAFV, RESTV | ZEBOV, SEBOV, BEBOV | ZEBOV | ZEBOV |
| Bundibugyo ebolavirus | Included | Included | Not listed | Not listed |
| Target | VP40 | VP40 and EBOV | VP40 | GP, NP, VP40 |
| Blood sample | 15 µL fingerstick blood sample | 20 µL whole blood | 50 µL whole blood | 50 µL whole blood |
| Analytical sensitivity | 0.1 ng/mL or 0.0015 ng/test | 53 ng/mL or 1.06 ng/test | 250 ng/mL or 12.5 ng/test | Unknown |
| Time to result | 15 minutes | 30 minutes | 15 minutes | Unknown |
| Regulatory path | Working toward FDA 510(k) clearance | FDA EUA, WHO EUAL, FDA 510(k) de novo | FDA EUA | WHO EUAL |
Ebolavirus coverage
Bundibugyo ebolavirus
Target
Blood sample
Analytical sensitivity
Time to result
Regulatory path
GoldN Reader: track, trace, and semi-quantitative readout.
GoldN™ Easy to Use Ebola Rapid Antigen Test can operate as a visual rapid antigen test. The GoldN Reader adds fluorescent signal reading, semi-quantitative result capture, and traceable testing records for clinical validation and outbreak programs.
- Reads fluorescence signal from the lateral-flow cassette.
- Tracks test events and supports traceable result records.
- Supports semi-quantitative output for validation datasets.
GoldN Reader video
The video shows the reader concept and the workflow direction for trackable, semi-quantitative testing.
NOVODX is seeking partners for clinical validation.
The next step for GoldN™ Easy to Use Ebola Rapid Antigen Test is clinical validation with partners that can support outbreak-relevant specimens, study execution, and regulatory-grade performance data.
Discuss clinical validationWorking toward FDA 510(k) clearance.
NOVODX is preparing the evidence path for FDA engagement and 510(k) clearance while final labeling claims are established through clinical validation and regulatory review.