sample volume
Whole blood (venous or fingerstick), EDTA plasma, or serum
Ebola rapid antigen testing
Rapid Ebola antigen testing for earlier outbreak decisions.
GoldN™ Easy to Use Ebola Rapid Antigen Test is a stand-alone Ebola rapid antigen test for institutional and outbreak-response workflows, with 15 µL sample input, 15-minute results, VP40 targeting, and feasibility-stage analytical sensitivity of 0.1 ng/mL.
time to result
Rapid stand-alone lateral-flow workflow
target antigen
Designed for Ebola antigen detection in development-stage work
analytical sensitivity
Also expressed as 0.0015 ng/test in feasibility-stage data
Product overview
A focused Ebola antigen test for operational clarity.
GoldN is being developed for Ebola antigen detection in outbreak-response and institutional settings, with VP40 targeting and a 15 µL workflow.
Product visual placeholder: cassette render or validated assay image
Format
Stand-alone analogue Ebola rapid antigen test
Target
VP40
Sample types
Whole blood, EDTA plasma, serum
Sample volume
15 µL
Time to result
15 minutes
Status
TRL4, additional validation and regulatory engagement pending
The diagnostic gap
Outbreak response depends on speed when centralized workflows add delay.
Molecular testing remains essential, but transport, infrastructure, and staffing can extend turnaround in fast-moving settings.
GoldN approach
Low sample volume, 15-minute workflow, and feasibility-stage analytical sensitivity.
Current feasibility data indicate 0.1 ng/mL analytical sensitivity, equivalent to 0.0015 ng/test.
How it works
Simple analogue workflow from sample to line-based result.
Designed for clear training, protocol alignment, and institutional implementation planning.
01
Collect sample
Fingerstick or venous whole blood, EDTA plasma, or serum.
02
Apply sample
Add 15 µL sample and buffer to the cassette per instructions.
03
Wait 15 minutes
Allow the lateral-flow test to develop.
04
Interpret result
Read control and test lines according to reporting protocol.
Performance proof points
Analytical and operational differentiation at a glance.
Current data highlight lower listed analytical detection limit, lower sample volume, and a 15-minute workflow.
Analytical sensitivity values are based on feasibility-stage data. Final performance claims remain subject to additional validation and regulatory review.
Ebolavirus coverage
Designed for broad Ebolavirus coverage.
Current inclusivity work covers five Ebolavirus variants under development-stage evaluation.
Comparator landscape
Procurement-focused comparison of listed Ebola antigen tests.
Comparison is limited to status, sample input, analytical sensitivity, time to result, and Ebolavirus coverage.
| Metric | GoldN™ Easy to Use Ebola Rapid Antigen Test | OraQuick Ebola Rapid Antigen Test | DPP Ebola Antigen System | SD Q Line Ebola Zaire Ag |
|---|---|---|---|---|
| Regulatory / development status | TRL4 | FDA EUA, WHO EUAL, FDA 510(k) de novo | FDA EUA | WHO EUAL |
| Target | VP40 | VP40 and EBOV | VP40 | GP, NP, VP40 |
| Sample type | Whole blood; EDTA plasma; serum | Whole blood; cadaveric oral fluid | Whole blood; EDTA plasma | Whole blood; EDTA plasma; serum |
| Sample size | 15 µL | 20 µL | 50 µL | 50 µL |
| 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 min | 30 min | 15 min | Unknown |
| Ebolavirus coverage | ZEBOV, SEBOV, BEBOV, TAFV, RESTV | ZEBOV, SEBOV, BEBOV | ZEBOV | ZEBOV |
GoldN™ Easy to Use Ebola Rapid Antigen Test
Regulatory / development statusTRL4
TargetVP40
Sample typeWhole blood; EDTA plasma; serum
Sample size15 µL
Analytical sensitivity0.1 ng/mL or 0.0015 ng/test
Time to result15 min
Ebolavirus coverageZEBOV, SEBOV, BEBOV, TAFV, RESTV
OraQuick Ebola Rapid Antigen Test
Regulatory / development statusFDA EUA, WHO EUAL, FDA 510(k) de novo
TargetVP40 and EBOV
Sample typeWhole blood; cadaveric oral fluid
Sample size20 µL
Analytical sensitivity53 ng/mL or 1.06 ng/test
Time to result30 min
Ebolavirus coverageZEBOV, SEBOV, BEBOV
DPP Ebola Antigen System
Regulatory / development statusFDA EUA
TargetVP40
Sample typeWhole blood; EDTA plasma
Sample size50 µL
Analytical sensitivity250 ng/mL or 12.5 ng/test
Time to result15 min
Ebolavirus coverageZEBOV
SD Q Line Ebola Zaire Ag
Regulatory / development statusWHO EUAL
TargetGP, NP, VP40
Sample typeWhole blood; EDTA plasma; serum
Sample size50 µL
Analytical sensitivityUnknown
Time to resultUnknown
Ebolavirus coverageZEBOV
Comparator values are based on referenced presentation materials. GoldN values reflect feasibility-stage analytical data and remain subject to additional validation.
Deployment fit
Built for government and institutional evaluation.
Positioned for organizations planning, evaluating, and procuring outbreak-response diagnostics.
Deployment visual placeholder: public-health or response operations
Outbreak response
Supports rapid near-patient workflows when isolation and triage speed matter.
Public-health stockpiles
Compact format suited to preparedness planning and emergency deployment programs.
Hospitals and isolation units
Operationally simple workflow for institutional teams and controlled clinical settings.
Field and resource-limited settings
Designed for practical use where centralized infrastructure can delay decisions.
Institutional evaluation
Structured for technical review by ministries of health, NGOs, and procurement groups.
Procurement readiness
Supports dossier-led discussions while validation and regulatory milestones advance.
Evidence and status
Current data, clear next steps.
GoldN is currently at Technology Readiness Level 4. Feasibility work supports current analytical sensitivity and inclusivity targets. NOVODX is advancing additional analytical validation, clinical evaluation planning, and regulatory engagement before final labeling claims are established.
Current stageTRL4 with assay feasibility data and additional development work in progress.
Validation pathPlanned analytical validation includes sensitivity, inclusivity, cross-reactivity, precision, robustness, and stability.
Regulatory pathNOVODX is advancing regulatory engagement and clinical evaluation planning before final claims are established.
Development notice
GoldN™ Easy to Use Ebola Rapid Antigen Test is under development and is not currently available for sale in the United States or internationally. The test has not been cleared or approved by FDA and is not WHO-listed. Performance information reflects feasibility-stage analytical data and remains subject to completion of planned validation, clinical evaluation, and regulatory review.
Procurement and preparedness
Evaluate GoldN for Ebola outbreak preparedness.
For government agencies, NGOs, hospitals, institutional buyers, and outbreak-response partners evaluating rapid Ebola antigen testing options.