Qualitative Detection of Ebola Virus NP Antigen in Serum / Plasma — Result in 15 Minutes
Ebola virus disease (EVD) is a severe, often fatal illness caused by Ebola virus (EBOV), a member of the Filoviridae family. First identified in 1976 near the Ebola River in the Democratic Republic of Congo, EBOV causes sporadic outbreaks predominantly in sub-Saharan Africa with case fatality rates historically ranging from 25% to 90%. The virus is classified as a Biosafety Level 4 (BSL-4) pathogen due to its high transmissibility through direct contact with infected body fluids and the absence of widely available approved antivirals for most outbreak settings.
EBOV nucleoprotein (NP) is the most abundantly expressed viral protein during active infection and the primary structural component encapsidating the viral RNA genome. Three properties make NP antigen the preferred direct detection target: (1) NP appears in serum early in the clinical course, coinciding with the onset of fever and systemic symptoms; (2) antigen concentrations during the acute viraemic phase are sufficient for lateral flow immunoassay detection without sample enrichment; (3) highly specific monoclonal antibody pairs against EBOV NP enable a sensitive and specific sandwich immunoassay format with minimal cross-reactivity to other filoviruses or common pathogens.
Rapid point-of-care antigen detection provides a critical complement to RT-PCR in outbreak response settings where laboratory infrastructure is limited, enabling rapid case identification and isolation to interrupt transmission chains. The WHO has included rapid antigen tests for Ebola among its Emergency Use Listing criteria for outbreak response diagnostics.
The Sekbio Ebola Virus Antigen Rapid Test Card (SEK-G101) is a qualitative colloidal gold lateral flow immunoassay for the detection of Ebola virus (EBOV) nucleoprotein (NP) antigen in human serum or plasma. The assay uses a sandwich format: a gold-conjugated mouse anti-EBOV NP antibody on the conjugate pad captures EBOV NP antigen in the specimen; the resulting immune complex migrates along the nitrocellulose membrane and is captured by a second anti-EBOV NP antibody pre-coated on the test line (T), producing a visible red band. A control line (C) coated with goat anti-rabbit IgG antibody captures the gold-labelled rabbit IgG internal control, confirming adequate sample migration in every valid test.
A positive result must be confirmed by an orthogonal diagnostic method (e.g., RT-PCR) in conjunction with clinical symptoms and patient history. The test is for professional use only in settings with appropriate BSL-4 biosafety provisions.
Ebola virus is classified as a Biosafety Level 4 (BSL-4) pathogen. All specimen handling must comply with applicable national and institutional biosafety regulations. Consult your biosafety officer before testing. Wear appropriate PPE including gloves, gown, and respiratory and eye protection throughout specimen collection and testing. All used test devices, specimens, and potentially contaminated materials must be disposed of as biohazardous waste in accordance with applicable local laws and regulations.
For professional use only. This test is not intended for home or self-testing. Any reactive result must be reported to the appropriate public health authority and confirmed by RT-PCR at a reference laboratory.
Performance data based on recombinant Ebola NP protein reference material.
| Parameter | Protocol | Result |
|---|---|---|
| Specificity (clinical) | 300 random clinical specimens | 300/300 negative (100%) |
| Negative Reference Panel | 10 enterprise negative reference specimens | 10/10 negative (100%) |
| Positive Reference Panel | 10 enterprise positive reference specimens | 10/10 positive (100%) |
| Limit of Detection (LoD) | 3 LoD reference specimens tested | 3/3 positive (100%) |
| Reproducibility | 1 reproducibility reference specimen × 10 replicates | 10/10 positive; uniform band intensity |
Enterprise reference material is based on recombinant Ebola NP protein. Clinical sensitivity in outbreak settings may vary. Positive results must be confirmed by RT-PCR.
Result available in 15 minutes from sample addition with no laboratory equipment required. Enables rapid case identification at point of care — critical for outbreak response where delays in detection allow further transmission.
Validated for both serum (SST) and plasma (EDTA, citrate, or heparin). 30 µL specimen volume. Specimens may be stored at 2°C–8°C for up to 3 days or frozen at −20°C for extended storage with up to 3 freeze-thaw cycles.
Detects EBOV nucleoprotein antigen directly — a marker of active viral replication — rather than the host immune response. NP is the most abundantly expressed EBOV protein, enabling detection during the acute viraemic phase when transmission risk is highest.
Stored at 2°C–30°C with no cold chain requirement. 12-month shelf life supports pre-positioning and field deployment in outbreak-prone regions of sub-Saharan Africa and West Africa where cold chain infrastructure may be limited.
Manufactured under ISO 13485-certified quality management. CE marked for IVD use. Full technical documentation available for regulatory registration in the EU, African Union member states, and other target markets.
Custom branding on test cards and outer cartons. Multilingual IFU printing in English, French, Portuguese, Arabic, and other languages for West African and Central African target markets. Contact Sekbio for volume-based OEM pricing.
Equilibrate all kit components and specimen to room temperature (15°C–30°C) before starting. Ensure BSL-4 biosafety precautions are in place.
Remove the foil pouch from storage and allow it to equilibrate to room temperature before opening. Remove the test card from the pouch, place on a clean, flat surface, and label with the sample ID. Use the card immediately after opening the pouch.
Hold the dropper vertically. Add 1 drop (~30 µL) of serum or plasma to the sample well (S), ensuring no air bubbles are introduced. Immediately add 1 drop (~30 µL) of sample diluent to the same sample well (S). Start the timer immediately.
Wait for coloured band(s) to appear. Read the result at exactly 15 minutes. Do not interpret results after 20 minutes — results are unreliable beyond this time point. Report any positive result immediately per local outbreak notification protocols.
Any visible color in the Test line (T) region constitutes a positive result, regardless of intensity.
Both C and T bands appear. EBOV NP antigen detected at or above the assay limit of detection. Consistent with active Ebola virus infection. Confirm immediately by RT-PCR and report to public health authorities per outbreak notification protocols.
Only C band appears. EBOV NP antigen not detected. Does not exclude Ebola virus infection — antigen may be undetectable before onset of viraemia, at a late disease stage, or if antigen levels are below the assay LoD. If clinical symptoms persist and epidemiological risk is high, retest with RT-PCR.
No C band appears. Test is invalid regardless of T-line status. Discard result. Review the procedure and repeat with a new test card. Ensure specimen volume was correct and sample diluent was added immediately after specimen. If problem persists, contact your local distributor.
Any shade of color in the T line region should be considered a positive result. Results read after 20 minutes may be unreliable and should not be reported.
Materials required but not provided: specimen collection container, timer, disposable gloves, and appropriate PPE per BSL-4 biosafety requirements.
During Ebola outbreaks, rapid identification of EBOV-positive cases is essential to interrupt transmission chains. A 15-minute result at the point of care enables immediate isolation decisions before RT-PCR confirmation is available, reducing the window of potential nosocomial or community transmission.
In sub-Saharan African and West African outbreak settings where laboratory infrastructure is limited, a no-equipment rapid antigen test enables frontline health workers to assess febrile patients at Ebola Treatment Units (ETUs) and community health posts without cold chain dependency.
During declared Ebola outbreaks, airport and border health authorities may deploy rapid antigen tests to screen travellers from affected countries presenting with febrile illness and epidemiological exposure history — complementing temperature screening and symptom questionnaires.
The 12-month shelf life at room temperature and compact format make this test suitable for national and international emergency stockpiling. Governments, NGOs, and humanitarian response organizations can pre-position test kits in high-risk regions ahead of outbreak events.
The Sekbio Ebola Virus Antigen Rapid Test Card (SEK-G101) is a qualitative colloidal gold lateral flow immunoassay that detects Ebola virus (EBOV) nucleoprotein (NP) antigen in human serum or plasma within 15 minutes. The assay uses a sandwich format with gold-conjugated anti-EBOV NP antibody and a capture antibody on the test line. A positive result — both C and T lines visible — indicates EBOV NP antigen was detected at or above the assay limit of detection. Any reactive result must be confirmed by RT-PCR and reported to the appropriate public health authority. The test is for professional use only in settings with appropriate BSL-4 biosafety provisions.
Ebola virus nucleoprotein (NP) is the most abundantly expressed viral protein during active EBOV infection. It encapsidates the viral RNA genome and is produced at very high levels in infected cells throughout the viraemic phase. NP antigen appears in serum early in the clinical course — coinciding with the onset of fever and systemic symptoms — and reaches concentrations sufficient for lateral flow immunoassay detection without sample enrichment. Highly specific and high-affinity monoclonal antibody pairs against EBOV NP are available for sandwich assay development, and NP shows low cross-reactivity with other filoviruses (Marburg, Sudan virus) when correctly paired antibodies are used, making it the preferred direct detection target for EBOV-specific rapid antigen assays.
POSITIVE: Both C and T bands appear. Any visible T-line color, regardless of intensity, constitutes a positive result indicating EBOV NP antigen detection. Confirm by RT-PCR and notify public health authorities immediately.
NEGATIVE: Only C band appears; no T line visible. EBOV NP antigen was not detected. Does not exclude Ebola virus infection — antigen may be below the LoD before onset of viraemia, late in disease, or if specimen was improperly collected or stored. If clinical symptoms persist and epidemiological risk is high, retest with RT-PCR.
INVALID: C band fails to appear regardless of T-line status. Test result is invalid. Discard result, review procedure, and repeat with a new test card. If repeated invalids occur, contact your distributor.
The Ebola Virus Antigen Rapid Test Card (SEK-G101) is validated for human serum or plasma only. Serum is collected by venipuncture without anticoagulant, allowed to clot, then centrifuged. Plasma is collected into EDTA, citrate, or heparin tubes and centrifuged. Each test requires 30 µL of serum or plasma plus 30 µL of the provided sample diluent. Specimens may be stored at 2°C–8°C for up to 3 days or frozen at −20°C for extended storage (limit freeze-thaw cycles to ≤3). Specimens with severe lipaemia, haemolysis, or turbidity are not acceptable. Results obtained with other specimen types are unreliable and should not be reported.
Ebola virus is classified as a BSL-4 pathogen. All specimen collection, handling, and testing must comply with applicable national and institutional biosafety regulations for BSL-4 agents. Consult your biosafety officer before testing. Wear appropriate PPE including gloves, gown, and respiratory and eye protection. Do not eat, drink, or smoke in testing areas. Dispose of all used test devices, specimens, and potentially contaminated materials as biohazardous waste per applicable laws. This test is for professional use only. Any positive result must be reported to the appropriate public health authority and confirmed by RT-PCR at a reference laboratory.
Store at 2°C–30°C in a dry location, protected from direct sunlight. Do not freeze. Shelf life is 12 months from the date of manufacture. The test card is stable until the expiry date on the foil pouch and outer carton, provided the pouch remains sealed. Before use, equilibrate all kit components to room temperature (15°C–30°C) — if stored refrigerated, allow at least 30 minutes. Once removed from the foil pouch, use the test card immediately. Check the kit label for lot-specific expiration date.
Yes. Sekbio offers full OEM and private label services for the Ebola Virus Antigen Rapid Test Card: custom branding on test cards and outer cartons, multilingual IFU printing (English, French, Portuguese, Arabic, and other languages available for West and Central African markets), and custom packaging design. Technical documentation packages for CE marking or local regulatory registration are available. Contact info@sekbio.com with your target market, annual volume estimate, and brand requirements for a dedicated OEM quotation.
ISO 13485-certified. CE marked. Available in 25-test kits and bulk OEM supply. Contact Sekbio for pricing, samples, and regulatory documentation.
Sekbio supplies validated anti-EBOV NP monoclonal antibody pairs for CLIA, ELISA, and lateral flow development — including the same clones used in the SEK-G101 kit, available as bulk raw material for OEM IVD manufacturers developing their own Ebola diagnostics.
View Antibody Raw Materials →Explore Sekbio's full rapid test portfolio — covering infectious disease, cardiac markers, hormones, and inflammation biomarkers in colloidal gold and fluorescence lateral flow formats. OEM supply with CE marking documentation support for global markets.
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