Parathyroid Hormone — Humanized + Mouse mAb for Intact PTH CLIA Assay Development
Parathyroid Hormone (PTH) is an 84 amino acid peptide hormone (9.4 kDa) produced by the chief cells of the four parathyroid glands. PTH is the primary regulator of calcium and phosphate homeostasis: it stimulates osteoclast-mediated bone resorption (raising serum calcium), increases renal calcium reabsorption, and stimulates renal 1α-hydroxylase to produce active vitamin D (1,25-dihydroxyvitamin D), which further increases intestinal calcium absorption.
Intact PTH measurement (iPTH, the biologically active 1-84 form) is essential for diagnosing:
Sekbio's PTH antibody pair uses a humanized detection antibody (PTH-130-2H) targeting the N-terminal 1-34 region and a mouse capture antibody (PTH-130-3M) targeting the C-terminal 39-84 region — the classic two-site sandwich configuration for intact PTH (iPTH) CLIA, reducing HAMA interference in the CKD patient population who receive the majority of PTH tests.
Humanized detection antibody + mouse capture antibody for two-site intact PTH sandwich CLIA assay development.
| Catalog No. | Product Name | Format | Epitope | Role | Purity | Platform | Storage |
|---|---|---|---|---|---|---|---|
| PTH-130-2H | Humanized Anti-PTH mAb (Detection) | Humanized IgG | N-terminal (1-34) | Detection | >95% SDS-PAGE | CLIA | +2°C to +8°C |
| PTH-130-3M | Mouse Anti-PTH mAb (Capture) | Mouse IgG | C-terminal (39-84) | Capture | >95% SDS-PAGE | CLIA | +2°C to +8°C |
All antibodies supplied in PBS pH 7.2. MOQ 1 mg. OEM quantities (10 mg–gram scale) available. Contact info@sekbio.com for bulk pricing, lot availability, and PTH antigen supply.
Engineered for the two-site intact PTH specificity, HAMA resistance, and sensitivity required in clinical parathyroid disorder diagnostics.
PTH-130-2H uses a human IgG constant region, substantially reducing HAMA interference. This is critical for PTH assays because CKD patients — the largest clinical population requiring regular PTH monitoring — frequently receive therapeutic antibodies (eculizumab, denosumab) that can trigger HAMA responses, causing false results with all-mouse antibody CLIA systems.
PTH-130-2H targets the N-terminal 1-34 region (biologically active) and PTH-130-3M targets the C-terminal 39-84 region. This two-site configuration is the standard second-generation iPTH assay architecture, measuring intact PTH (1-84) and minimising C-terminal fragment interference compared to single-site C-terminal assays.
Normal intact PTH is 15–65 pg/mL, but CKD patients with secondary hyperparathyroidism may have iPTH >1,000 pg/mL (KDIGO target: 2–9× ULN). The PTH-130-2H / PTH-130-3M pair supports a wide calibration range enabling single-assay measurement across this full clinical spectrum without hook effect.
Intraoperative PTH monitoring requires rapid (<15 minutes) measurement of a >50% PTH decline after parathyroid gland resection to confirm curative surgery (Miami Criterion). The PTH-130-2H / PTH-130-3M pair's high affinity and sensitivity enable the rapid CLIA assay performance required for IOPTH monitoring on point-of-care analyzers.
Both PTH antibodies are manufactured under ISO 13485 QMS with full batch documentation, Certificate of Analysis, and inter-batch CV <10%. Suitable for CE-marked PTH CLIA analyzer reagents, NMPA-registered kits, and clinical-grade nephrology and endocrinology assay development.
MOQ 1 mg for R&D evaluation; gram-scale OEM production supply from Shenzhen, China. Export experience to Europe (Germany, Italy, Turkey), North America, South Korea, and Japan for nephrology and endocrinology CLIA analyzer reagent manufacturers. Full CoA and lot documentation with each shipment.
Antibody pair validated for hyperparathyroidism diagnosis, CKD monitoring, intraoperative PTH, and OEM CLIA kit development.
Primary HPT is the third most common endocrine disorder, caused by autonomous PTH overproduction from a parathyroid adenoma. Diagnosis requires demonstration of inappropriately elevated PTH (typically >65 pg/mL) in the context of hypercalcemia. Accurate iPTH CLIA using PTH-130-2H / PTH-130-3M enables differential diagnosis from hypercalcemia of malignancy (suppressed PTH) and familial hypocalciuric hypercalcemia (mildly elevated PTH).
Secondary HPT is universal in CKD stage G3b and beyond, driven by phosphate retention, vitamin D deficiency, and reduced calcium absorption. KDIGO guidelines recommend iPTH monitoring every 3–12 months in CKD G3–G5D (dialysis), targeting 2–9× ULN. High-frequency PTH monitoring in dialysis patients requires a CLIA assay with HAMA resistance — making PTH-130-2H's humanized format particularly valuable for this clinical population.
The Miami Criterion for parathyroidectomy requires >50% PTH decline within 10 minutes of gland resection vs. pre-incision baseline. IOPTH monitoring enables single-gland parathyroidectomy (avoiding bilateral neck exploration) with cure rates >95% in appropriately selected primary HPT patients. Rapid CLIA assays using PTH-130-2H / PTH-130-3M support development of IOPTH capable analyzer reagents with turnaround <15 minutes.
IVD manufacturers developing CE-marked or NMPA-registered intact PTH CLIA analyzer kits can integrate Sekbio's PTH-130-2H / PTH-130-3M pair with ISO 13485-compliant batch documentation for regulatory submissions. Contact info@sekbio.com or visit our Platforms page for custom antibody development and additional PTH clone options.
Technical and commercial questions from IVD R&D engineers and procurement teams.
Parathyroid Hormone (PTH) is an 84 amino acid peptide regulating calcium and phosphate homeostasis. Intact PTH (iPTH) measurement is essential for diagnosing primary hyperparathyroidism (elevated PTH + hypercalcemia), secondary HPT in CKD, hypoparathyroidism, and intraoperative PTH monitoring during parathyroid surgery. Normal range: 15–65 pg/mL.
Sekbio supplies: PTH-130-2H (humanized IgG detection antibody targeting PTH N-terminal 1-34, >95% purity) and PTH-130-3M (mouse IgG capture antibody targeting PTH C-terminal 39-84, >95% purity). Both available from MOQ 1 mg with ISO 13485-compliant documentation.
C-terminal assays measure intact PTH plus biologically inactive C-terminal fragments (7-84 PTH), overestimating active PTH in CKD patients where fragments accumulate. Two-site intact PTH assays (like PTH-130-2H / PTH-130-3M) target both N-terminal (1-34) and C-terminal (39-84) epitopes, measuring only intact 1-84 PTH plus 7-84 PTH — the second-generation iPTH standard recommended by KDIGO guidelines.
CKD patients — who require the most frequent PTH monitoring — often receive therapeutic antibodies that can trigger HAMA. PTH-130-2H's humanized format (human IgG constant region) substantially reduces HAMA interference, preventing false-high or false-low PTH results in dialysis patients receiving treatment with denosumab, eculizumab, or other biologic therapies.
Normal range: 15–65 pg/mL. Primary HPT: PTH inappropriately elevated with concurrent hypercalcemia. CKD secondary HPT targets (KDIGO): 2–9× ULN (30–585 pg/mL by stage). Intraoperative monitoring (Miami Criterion): >50% PTH decline within 10 minutes of parathyroid resection confirms curative surgery. Post-surgical hypoparathyroidism: iPTH <10 pg/mL at 4–6 hours predicts hypocalcemia.
PTH-130-2H / PTH-130-3M is validated for CLIA (chemiluminescence immunoassay) sandwich format for intact PTH quantification in serum and EDTA plasma. The two-site N+C-terminal configuration is optimised for second-generation iPTH assay development on automated CLIA analyzers. Contact info@sekbio.com to request the technical datasheet or visit our Platforms page.
Request the full technical datasheet, PTH antibody pair specifications, or discuss OEM supply with our team.