Quantitative Fluorescent Immunoassay for Male Fertility Assessment
The SP10 FIA Test is a high-performance fluorescent immunoassay for the quantitative measurement of SP10 — the sperm-specific acrosomal membrane glycoprotein (ACRV1) — in human semen. As SP10 is expressed exclusively by spermatozoa and absent from all somatic cells, it provides a highly specific, objective biomarker for male fertility assessment.
Built on a validated anti-SP10 monoclonal antibody pair optimized for fluorescence lateral flow platforms, this assay delivers quantitative results across a wide dynamic range and demonstrates complete clinical separation between azoospermic and normozoospermic individuals — with no overlap observed in clinical validation samples.
Six engineering priorities that make this antibody pair the right choice for your platform.
Calibrated from 0.6 to 10,000 ng/mL — over 4 decades — enabling a single assay to cover the full clinical spectrum from severely oligozoospermic to hyperfertile samples.
S/N of 9 at the lowest calibrator (0.6 ng/mL), rising to over 10,000 at the upper range — delivering confident detection even at minimal antigen concentrations.
Within-run CV ≤ 7.3% across two clinically relevant concentrations (16 and 400 ng/mL, n = 10), well within IVD precision requirements.
SP10 (ACRV1) is expressed exclusively in post-meiotic spermatids. Zero cross-reactivity with somatic cell proteins eliminates background interference from non-sperm material.
Validated on clinical semen samples from confirmed azoospermic patients and normal fertile males, demonstrating complete separation with no overlap between groups.
Antibody pair is available as raw material for licensed IVD manufacturers. Compatible with FIA strip and ELISA formats; optimized for fluorescence reader-based systems.
All data generated using Sekbio's anti-SP10 monoclonal antibody pair in an FIA sandwich format.
Eight calibrators spanning 0.6 to 10,000 ng/mL demonstrate a robust dose-response relationship. The blank (S1) produces a near-zero T/C of 0.001, confirming negligible non-specific signal. Detection at 0.6 ng/mL achieves an S/N of 9, well above the conventional LoD threshold (S/N ≥ 3).
| Calibrator | Concentration (ng/mL) | Run 1 — T/C | Run 2 — T/C | Avg. T/C | S/N vs. Blank |
|---|---|---|---|---|---|
| S1 — Blank | — | 0.001 | 0.001 | 0.001 | — |
| S2 | 0.6 | 0.008 | 0.008 | 0.008 | 9 |
| S3 | 3.2 | 0.039 | 0.034 | 0.037 | 43 |
| S4 | 16.0 | 0.193 | 0.189 | 0.191 | 226 |
| S5 | 80 | 1.003 | 0.966 | 0.984 | 1,165 |
| S6 | 400 | 3.210 | 3.217 | 3.214 | 3,803 |
| S7 | 2,000 | 7.014 | 6.940 | 6.977 | 8,257 |
| S8 | 10,000 | 9.492 | 8.882 | 9.187 | 10,872 |
| T = Test line fluorescence; C = Control line fluorescence; T/C = signal ratio; S/N = signal-to-noise ratio vs. blank (S1). | |||||
Repeatability was assessed at two clinically relevant concentrations across 10 replicates each. Both levels achieve CV values well within the IVD precision acceptance criterion of ≤ 10%.
| Concentration (ng/mL) | Replicates (n) | Min T/C | Max T/C | Avg. T/C | CV (%) |
|---|---|---|---|---|---|
| 16 | 10 | 0.175 | 0.219 | 0.191 | 7.3% |
| 400 | 10 | 0.712 | 3.291 | 2.954 | 6.1% |
| Acceptance criterion: CV ≤ 10% (IVD industry standard). | |||||
The assay was evaluated on de-identified clinical semen samples from confirmed azoospermic patients (n = 10) and normal fertile males (n = 10). Results demonstrate complete, non-overlapping separation between groups.
n = 10 confirmed azoospermic patients
n = 10 normal fertile males
The SP10 antibody pair is validated across multiple IVD formats and development contexts.
Quantitative or semi-quantitative FIA cassettes and strips for point-of-care male fertility screening. Compatible with standard fluorescence readers at clinics and home-use settings.
The antibody pair is validated for sandwich ELISA format, enabling quantitative measurement in research or clinical laboratory settings where higher throughput is required.
Capture and detection antibodies are available in bulk for licensed IVD manufacturers. Sekbio supports full OEM integration with consistent lot-to-lot performance and ISO 13485-compliant supply chain.
Objective, quantitative SP10 measurement for semen quality studies, biomarker correlation research, and male infertility investigation — without the subjectivity of manual sperm counting.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply and partnership arrangements with our team.