Qualitative Detection of HPV E7 Oncoprotein in 15 Minutes — Types 16, 18, 31, 33, 45
The HPV E7 oncoprotein is the primary cancer-driving protein encoded by high-risk Human Papillomavirus (HPV) types. It promotes malignant transformation by binding to and inactivating the retinoblastoma tumor suppressor protein (pRb), disrupting normal cell cycle checkpoints and enabling uncontrolled proliferation in cervical epithelial cells.
Unlike HPV DNA, which can be detected transiently in women who will naturally clear the infection, E7 oncoprotein is overexpressed only when active oncogenic transformation is occurring. Detection of E7 protein therefore provides a direct indication of clinically significant, progressive infection — more specifically associated with high-grade cervical intraepithelial neoplasia (CIN2/3) and invasive cervical carcinoma than HPV DNA positivity alone.
Approximately 14 HPV types are classified as high-risk oncogenic types. The E7 protein shares conserved structural epitopes across these types, which allows a single anti-E7 antibody to detect E7 oncoprotein from multiple high-risk HPV types — including 16, 18, 31, 33, and 45 — collectively responsible for over 85% of HPV-attributable cervical cancers.
The Sekbio HPV Oncoprotein Rapid Test Kit (REF SEK-G012) is a single-use colloidal gold lateral flow immunoassay for the qualitative, in vitro detection of HPV E7 oncoprotein in female endocervical swab specimens.
The test cassette contains one Test line (T) coated with anti-HPV E7 capture antibody, and one Control line (C). Because the anti-E7 antibody recognizes conserved epitopes shared across high-risk HPV types, the assay detects E7 oncoprotein from HPV types 16, 18, 31, 33, and 45 in a single test. The test does not differentiate between HPV types — a positive T line indicates the presence of HPV E7 oncoprotein from one or more detected types.
Results are read visually at 15 minutes. No laboratory equipment, reader, cold chain, or electrical supply is required during testing.
Suitable for gynecology clinics, colposcopy units, and low-resource settings.
Insert the sterile swab into the endocervical canal past the squamocolumnar junction. Rotate 360° for 15 seconds, withdraw, and place into the extraction tube with provided buffer. Mix well.
Remove the test cassette from its foil pouch. Hold the dropper vertically and add 2 drops (~60 µL) of specimen eluate to the sample well (S). Start the timer immediately.
Read results visually at exactly 15 minutes under good lighting. Any visible color at the Test line (T), however faint, is a positive result. Do not read after 20 minutes.
Once the foil pouch is opened, the test cassette must be used within 15 minutes (RH ≤ 70%).
The cassette has two lines: Control (C) and Test (T). The Control line must always appear for a valid test.
Control line (C) visible. Test line (T) absent. HPV E7 oncoprotein was not detected at or above the assay's detection threshold.
Both Control (C) and Test (T) lines visible. HPV E7 oncoprotein detected (types 16, 18, 31, 33, and/or 45). Any color at T, however faint, is positive. Confirmatory typing is recommended.
Control line (C) absent. The result is invalid regardless of the test line. Review the procedure and repeat with a new cassette. If the problem persists, contact your distributor.
Important: A positive result indicates detection of HPV E7 oncoprotein but does not identify the specific HPV type. HPV genotyping PCR or another confirmatory method is recommended before clinical decisions are made. The color intensity of the test line does not reflect disease severity.
The anti-E7 antibody recognizes conserved epitopes shared across multiple high-risk HPV types, enabling a single test to screen for the most clinically significant oncogenic types.
| HPV Type | Classification | E7 Detected by This Assay | Contribution to Cervical Cancer |
|---|---|---|---|
| HPV 16 | High-risk (Group 1) | ✓ Detected | ~50% of cervical cancers |
| HPV 18 | High-risk (Group 1) | ✓ Detected | ~20% of cervical cancers |
| HPV 31 | High-risk (Group 1) | ✓ Detected | ~5% of cervical cancers |
| HPV 33 | High-risk (Group 1) | ✓ Detected | ~3% of cervical cancers |
| HPV 45 | High-risk (Group 1) | ✓ Detected | ~3% of cervical cancers |
| Subtotal Coverage | — | 5 high-risk types | ~81% of HPV-attributable cervical cancers |
| IARC Group 1 carcinogens. The assay uses a single test line (T) — a positive result does not identify which specific type(s) are present. Cervical cancer attribution data: IARC/WHO. Type-specific identification requires HPV genotyping PCR. | |||
E7 oncoprotein is overexpressed only when the virus actively drives malignant transformation. Unlike HPV DNA tests, a positive E7 result indicates clinically significant oncogenic activity — directly associated with CIN2/3 and cervical carcinoma.
A single test line detects E7 oncoprotein from HPV types 16, 18, 31, 33, and 45 — collectively responsible for over 80% of HPV-attributable cervical cancers. One test, broad protection.
From cervical swab to visual result in 15 minutes. No laboratory equipment, electricity, or specialist technician required — suitable for gynecology clinics, mobile units, and resource-limited settings.
No false-positive cross-reactions with common cervical pathogens including C. trachomatis, N. gonorrhoeae, T. vaginalis, C. albicans, and HSV-1/2, nor with endogenous interferents at clinically relevant concentrations.
CE marked for EU/EEA market use, manufactured under ISO 13485 QMS. EU Authorized Representative: MedUnion S.L., Barcelona, Spain (EUDAMED SRN: ES-AR-000019366). CE technical documentation available for OEM partners.
Available for OEM and private label supply. Custom branding, multilingual IFU, and packaging design supported. MOQ and pricing available on request. Contact info@sekbio.com for a quotation.
Validated across three independent production lots (F10001, F10002, F10003). Acceptance criterion: color grade variation ≤ 0.5 grade on colorimetric reference card.
Serial dilutions of recombinant HPV E7 antigen spiked into sample diluent, tested in 10 replicates per concentration across three lots. All replicates at the stated LOD concentration produced a positive result.
| HPV Type (E7) | LOD Concentration | Color Grade at LOD | Δ Across Replicates | Result |
|---|---|---|---|---|
| HPV 16 E7 | 5 ng/mL | B2 | ≤ 0.5 grade | PASS ✓ |
| HPV 18 E7 | 0.5 ng/mL | B2– | ≤ 0.5 grade | PASS ✓ |
| LOD for HPV types 31, 33, 45 E7 may differ based on antibody affinity for each type's E7 protein. Full data available on request. | ||||
Intra-assay: 10 replicates within a single lot. Inter-lot: comparison between lots F10001 and F10002 at matched concentrations.
| Precision Metric | HPV 16 E7 | HPV 18 E7 | Criterion | Conclusion |
|---|---|---|---|---|
| Intra-assay Repeatability | Δ ≤ 0.5 grade | Δ ≤ 0.5 grade | Δ ≤ 0.5 grade | PASS ✓ |
| Inter-lot Reproducibility | Δ ≤ 0.5 grade | Δ ≤ 0.5 grade | Δ ≤ 0.5 grade | PASS ✓ |
Common cervical pathogens and endogenous interferents tested at clinically relevant concentrations. Criterion: no false-positive reactions.
| Substance | Category | False Positive? | Conclusion |
|---|---|---|---|
| Chlamydia trachomatis | Pathogen | No | PASS ✓ |
| Neisseria gonorrhoeae | Pathogen | No | PASS ✓ |
| Trichomonas vaginalis | Pathogen | No | PASS ✓ |
| Candida albicans | Pathogen | No | PASS ✓ |
| Herpes Simplex Virus 1/2 | Pathogen | No | PASS ✓ |
| Hemoglobin | Endogenous interferent | No | PASS ✓ |
| Mucin | Endogenous interferent | No | PASS ✓ |
| All substances tested at clinically relevant concentrations. Full anti-interference dataset available on request. | |||
Characterized reference samples. Criterion: all negatives test negative; all positives test positive; color grade difference ≤ 0.5 grade.
| Sample Type | Expected | Observed | Δ Color Grade | Conclusion |
|---|---|---|---|---|
| Negative reference samples | Negative | Negative (100%) | N/A | PASS ✓ |
| HPV E7 positive samples | Positive | Positive (100%) | ≤ 0.5 grade | PASS ✓ |
REF SEK-G012 — 25 Tests / Kit
| Component | Quantity | Description |
|---|---|---|
| Test Cassette | 25 pcs | Colloidal gold LFA, individually sealed in foil pouch with desiccant |
| Extraction Buffer | 1 vial | Sample diluent / extraction buffer |
| Disposable Dropper | 25 pcs | For adding ~60 µL specimen eluate to sample well |
| Package Insert (IFU) | 1 pc | Instructions for Use — multilingual available for OEM orders |
Not included: sterile cervical swab, collection tube, gloves, timer, biohazard waste container.
Use as an adjunct to HPV DNA testing to identify women with active E7 oncoprotein expression — indicating the highest clinical risk for CIN2+ — and prioritize them for colposcopy. Reduces over-referral of transient HPV infections that would self-resolve.
No laboratory equipment, electricity, or cold chain required during testing — making this assay practical for mobile screening units, community health centers, and primary care settings in Africa, Southeast Asia, and Latin America where cervical cancer burden is highest.
Monitor E7 oncoprotein status post-treatment (LEEP, conization) for high-grade CIN. Persistence of E7 oncoprotein after excision may indicate incomplete treatment or residual disease, supporting clinical decisions on re-treatment or follow-up scheduling.
Available for private label and OEM supply with custom branding, IFU localization, and packaging. CE marking technical documentation support for EU/EEA registration. Competitive MOQ for established IVD distributors and brands in 30+ countries.
IFU, analytical performance report, CE documentation, and OEM pricing available on request.