1. What Are Fertility Testing Antibody Pairs?

Fertility testing antibody pairs are matched sets of capture and detection monoclonal antibodies used in sandwich immunoassays to quantify reproductive hormones and fertility biomarkers in serum, plasma or whole blood. They are the core raw material components in chemiluminescent immunoassay (CLIA), fluorescence immunoassay (FIA), ELISA and lateral flow assay (LFA) platforms used in IVF clinics, fertility centers, hospitals and home testing devices.

Reproductive hormone quantification is among the most clinically sensitive areas in IVD — small measurement errors in AMH, FSH or LH can directly affect treatment decisions such as ovarian stimulation protocols, IVF cycle planning and PCOS diagnosis. This makes antibody pair performance — sensitivity, specificity, cross-reactivity, and lot-to-lot consistency — especially critical for fertility assay manufacturers.

The primary fertility biomarkers in the clinical IVD market include:

  • Ovarian reserve: Anti-Müllerian Hormone (AMH) — cycle-independent, stable marker for follicular pool assessment
  • Ovulation and pituitary function: Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) — the hormonal drivers of the ovarian cycle
  • Pregnancy detection: human Chorionic Gonadotropin (hCG) — the definitive marker for early pregnancy and trophoblastic disease
  • Sex hormone status: Estradiol (E2), Progesterone — ovarian activity, luteal phase support and IVF monitoring
  • Androgen assessment: Testosterone — PCOS workup, male hypogonadism and androgen excess disorders
  • Male fertility: SP10 (Acrosin-Binding Protein) — sperm function marker for point-of-care male fertility rapid tests

One Validation. Consistent Performance. Every Batch.

Sekbio fertility antibodies are manufactured at industrial scale with tight lot-to-lot CV and full ISO 13485-certified traceability. Validate once, produce with confidence.

2. Fertility Antibody Products

All products are available as matched antibody pairs (capture + detection), individual clones or colloidal gold conjugates. Click any product for full specifications and assay data.

Biomarker Clinical Use Formats Key Specs Details
AMH (Anti-Müllerian Hormone) Ovarian reserve, PCOS, IVF protocol planning CLIAELISAFIA Cycle-independent; detects 0.01–25 ng/mL range View AMH Antibody Pair
LH (Luteinizing Hormone) Ovulation detection, LH surge monitoring FIACLIALFA High sensitivity for LH surge (≥25 mIU/mL); no FSH cross-reactivity View LH Antibody Pair
FSH (Follicle-Stimulating Hormone) Ovarian reserve, menopause diagnosis, male hypogonadism CLIAFIAELISA Detects FSH beta subunit; no LH, TSH, hCG cross-reactivity View FSH Antibody Pair
hCG (human Chorionic Gonadotropin) Early pregnancy detection, trophoblastic disease monitoring LFACLIAFIA Detects intact hCG and beta subunit; LoD <5 mIU/mL View hCG Antibody Pair
Estradiol (E2) Ovarian follicle monitoring, IVF stimulation, menopause CLIAELISA High-affinity anti-E2 antibody; low cross-reactivity with E1, E3 View E2 Antibody
Progesterone Luteal phase assessment, IVF support monitoring, pregnancy CLIAELISA Validated in serum and whole blood; broad quantitative range View Progesterone Antibody
Testosterone PCOS diagnosis, male hypogonadism, androgen assessment CLIAELISA Detects free and total testosterone; low DHT cross-reactivity View Testosterone Antibody
SP10 (Acrosin-Binding Protein) Male fertility POC rapid test, sperm function assessment LFAFIA Sperm-specific marker; validated in seminal plasma matrix View SP10 Antibody
View Full Antibody Catalog
8
Fertility Biomarker Targets
<10%
Lot-to-Lot CV
30+
Countries Served
ISO
13485 Certified

3. Assay Formats Supported

Sekbio fertility antibody pairs are pre-validated for four IVD platforms, each with platform-specific recommended working concentrations and calibration data.

FIA (Fluorescence)

Time-resolved fluorescence and fluorescent microsphere conjugates for quantitative POCT analyzers. Primary format for LH, FSH, hCG and SP10 fertility rapid panels.

CLIA

Chemiluminescent immunoassay pairs for automated analyzer platforms. High-sensitivity formats for AMH, E2, Progesterone, Testosterone, LH and FSH.

ELISA

Sandwich ELISA-grade pairs for laboratory quantification. Biotin/streptavidin and HRP-conjugated detection antibodies available for all hormone targets.

Lateral Flow Assay (LFA)

Colloidal gold conjugates for qualitative and semi-quantitative POC testing. Validated for hCG (pregnancy test) and SP10 (male fertility rapid test).

Not sure which format suits your fertility assay? Sekbio's technical team advises on antibody pair selection, conjugation chemistry and calibration curve design based on your clinical detection range and platform. Contact us or explore our antibody development platforms for custom pair screening.

4. Why IVD Manufacturers Choose Sekbio for Fertility Antibodies

Fertility hormone assays operate at the intersection of clinical sensitivity and regulatory precision. A suboptimal antibody pair means incorrect AMH interpretation, missed LH surges or inaccurate hCG quantification — all with direct clinical consequences. Sekbio addresses this with pre-validated, production-grade antibody pairs that meet the performance demands of clinical fertility diagnostics.

Pre-Validated Pairs

Every fertility antibody pair is screened in a real sandwich immunoassay with calibration curves before catalog listing. You receive a pair that works on your target platform from day one.

Hormone Cross-Reactivity Controlled

Reproductive hormones share structural similarity — LH, FSH, hCG and TSH share the alpha subunit. Sekbio tests each pair against structurally related hormones; cross-reactivity data is provided in every datasheet.

Industrial Scale, IVD Grade

Produced in CHO or hybridoma bioreactors at batch sizes from 100 mg to gram scale, with full ISO 13485 batch documentation for CE and FDA regulatory submissions.

Technical Support Included

Our scientists support coating optimization, calibrator design and matrix interference troubleshooting for fertility hormone assays — included with every order.

5. Frequently Asked Questions — Fertility Testing Antibodies

What are fertility testing antibody pairs for IVD?

Fertility testing antibody pairs are matched sets of capture and detection antibodies used in sandwich immunoassays to quantify reproductive hormones in serum or whole blood. They are the core reagent components in CLIA, FIA, ELISA and LFA diagnostic platforms for assessing ovarian reserve (AMH), ovulation (LH, FSH), pregnancy (hCG), and sex hormone status (E2, Progesterone, Testosterone).

Which fertility biomarkers does Sekbio supply antibody pairs for?

Sekbio supplies antibody pairs for eight targets: AMH, LH, FSH, hCG, Estradiol (E2), Progesterone, Testosterone and SP10. All pairs are pre-validated on at least one clinical assay platform before catalog release.

Why is AMH the preferred marker for ovarian reserve testing?

AMH is produced directly by granulosa cells in small antral follicles and remains stable throughout the menstrual cycle — unlike FSH and E2, which fluctuate significantly with cycle phase. This means AMH can be measured on any cycle day, making it more convenient and reproducible for ovarian reserve assessment. Sekbio's AMH antibody pair is pre-validated for ELISA and CLIA platforms with a detection range of 0.01–25 ng/mL.

What is SP10 and how is it used in male fertility IVD?

SP10 (Acrosin-Binding Protein, ACRBP) is a sperm-specific marker expressed on the acrosome of mature spermatozoa. Its concentration in seminal plasma correlates with sperm motility and acrosome integrity — providing a functional male fertility measure beyond total sperm count. Sekbio's SP10 antibody is validated for LFA and FIA formats used in point-of-care male fertility rapid tests.

How does Sekbio control cross-reactivity between structurally similar reproductive hormones?

LH, FSH, hCG and TSH all share a common alpha subunit, creating a risk of cross-reactivity in immunoassays. Sekbio selects antibody clones that target unique beta-subunit epitopes and screens every pair against the full panel of structurally related hormones before catalog listing. Cross-reactivity data is published in each product datasheet.

What is the minimum order quantity (MOQ) for fertility antibody pairs?

The standard MOQ is 1 mg per antibody clone, sufficient for initial assay feasibility studies. For scale-up and routine production, quantities from 10 mg to gram scale are available with full ISO 13485-certified batch documentation and Certificate of Analysis.

Can Sekbio develop custom antibody pairs for fertility targets not in the catalog?

Yes. Sekbio offers end-to-end custom antibody development for any reproductive hormone or fertility biomarker target. The typical timeline from antigen design to validated antibody pair is 8–12 weeks. Explore our antibody development platforms or contact our team to discuss your project.

Ready to Build Your Fertility Assay?

Request a sample, download datasheets, or speak with a Sekbio antibody scientist about your reproductive hormone assay requirements.

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