Reliable Assays for IVIG Testing

Posted: April 17, 2020

Immunoglobulin IVIG testing

Reliable testing for procoagulant contaminants

In order to reduce the risk of thromboembolic events, IVIG manufacturers need reliable assays to test procoagulant contaminants in IVIG preparations.

Diapharma offers a variety of products for sensitive safety testing to ensure of thrombogenic agents.

Prekallikrein Activity Assays

Specialty Range of PKA Assay Kits, Reagents & Controls

Fractionation of Human plasma to produce Human Albumin and Immunoglobulin preparations can result in concentration of PKA. Diapharma is excited to offer the highest quality PKA assay kits and reagents from Pathway Diagnostics!


  • Complete kits of matched reagents that are EP compliant
  • Standard & kit control calibrated against the 2nd PKA international Standard
  • Minimal batch-to-batch variation
  • Unique Immunoglobulin high-blank blocking reagent

Ordering Info:

PW30100 Prekallikrein Activator (PKA) Assay Kit
PW30200 Prekallikrein Activator (PKA) Assay Ig Kit
PW301EP Prekallikrein Activator (PKA) Assay Kit – EP method
PW302EP Prekallikrein Activator (PKA) Assay Ig Kit – EP method
PW30304 Human Prekallikrein Pool
PW51005 Just Positive™ PKA Control
PW52005 High Positive™ PKA Control
S820340 Chromogenix S-2302™

Immunoglobulin IVIG Testing



Chromogenic kit for determination of low levels of FXIa in enriched or highly purified protein

  • The most sensitive kit on the market
  • Low interference – ideal for in-process and final testing of immunoglobulin preparations
  • Reagents comprise highly purified components

IVIG immunoglobulin testing assays for procoagulant contaminants

Technothrombin® TGA


Fluorogenic assay for determination of thrombin generation

  • Give thrombotic potential a number
  • Ceveron® s100 for automated TGA or 96-well plate applications

IVIG immunoglobulin testing assays for procoagulant contaminants

Chromogenic substrates

S-2302™ (S820340)

  • Prekallikrein, kallikrein inhibitors, FXII

S-2366™ (S821090)

  • FXI, APC
S-2238™ (S820324)

  • Thrombin, prothrombin, antithrombin

S-2288™ (S820852)

  • Broad spectrum of serine proteases

All products are for research use only in the U.S. and Canada.


The Diapharma team brings a deep knowledge base and strong technical expertise to every customer interaction. Questions about any product in our lineup? We’re just a click or phone call away.

800.526. 5224 | |


8948 Beckett Road, West Chester, OH 45069