This Inorganic Pyrophosphatase (PPase) Residue Detection Kit uses the double-antibody sandwich ELISA method to detect residual PPase in mRNA vaccine products. PPase catalyzes the conversion of pyrophosphate to phosphate, promoting higher mRNA yields in production. However, PPase must be removed during purification to ensure product quality, and its residues must be tested to confirm effective removal.

The detection process involves adding both PPase standard and test samples to Anti-PPase-coated microtiter strips. Afterward, a biotin-labeled anti-PPase antibody and Streptavidin-HRP are added to form an antibody-antigen complex. TMB substrate is then added, and the color change from blue to yellow indicates the PPase amount in the sample. The color intensity is directly proportional to the PPase concentration.

The kit’s detection range is 0.25–16 ng/mL, with a lower detection limit of 0.165 ng/mL.

Feature

• Highly sensitive: Detecting as little as 0.165 ng/mL of Inorganic pyrophosphatase residuals in in-process and final biological samples.
• Ensures accuracy: The Inorganic pyrophosphatase residuals can be accurately detected with a recovery of 75%-125%.
• Specificity: Cooperate use with YEASEN Inorganic pyrophosphatase and can accurately detect the residuals.
• Stable: The difference between lot-to-lot is low, the kit property is not impacted under 37℃ for 7 days.
• Easy signal collection: Using Biotin-Streptavidin system, the signal can be stably enlarged.

Application

• Residual Inorganic pyrophosphatase test in biological products;
• Residual Protein Detection in mRNA Vaccine and Therapeutic Production;
• Purification Validation in Nucleic Acid Synthesis and In Vitro Transcription (IVT)

Specification

Property

Components

^*The Standard (36706-B) is Lyophilized powder.

Storage

This product should be stored at 2°C ~8°C. Unopened product is valid for one year.

^*Upon receipt of the kit, please check whether all components are complete and immediately store them in corresponding condition.

Figures

• Precision 

A) Repeatability

B) Intermediate precision

Table 1. The precision of Inorganic pyrophosphatase ELISA was assayed as the above scheme

10 duplicated were tested at 3 concentrations on the standard curve, and all the CV% were lower than 10% (Table 1A). 3 lot of Salt Active UltraNuclease ELISA kits were tested and the CV% were lower than 15% (Table 1B).

• Accuracy

Three concentrations of Inorganic Pyrophosphatase standards, high, medium and low, were added to the mRNA purified samples in equal proportions, while the high value spiked samples were made multiplicative dilutions.

Spiked recovery = measured value / (spiked standard x 50% + spiked specimen value x 50%)

Table 2. Accuracy Validation

The linear and spiked recoveries of Inorganic Pyrophosphatase in the doubly diluted samples, as well as the samples with different spiked concentrations, and in the unspiked samples, ranged from 80% to 120% (Table 2).

Documents:

Safety Data Sheet

36706_MSDS_HB250226.pdf

Manuals

36706_Manual_Ver.EN20250226.pdf