dsRNA ELISA Kits
During the drug substance manufacturing process for mRNA pharmaceuticals, including mRNA vaccines and mRNA therapeutics, double-stranded RNA (dsRNA) is produced as a by-product (impurity) during the in vitro transcription reaction.
Because dsRNA is immunogenic, it is considered an important quality control item for mRNA pharmaceuticals and is listed as a test item in the USP (United States Pharmacopeia).
This product is an ELISA kit for detecting dsRNA. It enables highly sensitive measurement with minimal influence from nucleic acid modifications or RNA chain length.
Features

- Consistent detection regardless of nucleic acid modification (unmodified U or m1ψ), chain length, or matrix effects
- Enables highly sensitive detection
- Includes not only the antibodies and chromogenic reagents, but also standards, buffers, and wash solutions required for the assay
Kit Performance
| Calibration curve range |
|
|---|---|
| Assay target | dsRNA (double-stranded RNA) |
| Analysis sample | mRNA solution |
| Measurement duration | Approx. 4.5 hours |
| Detection method | Colorimetric assay |
| Wavelength | Primary wavelength 450 nm Secondary wavelength 620 nm |
Example of Calibration Curve
Principle
This kit detects dsRNA by sandwich ELISA.
Each well of the assay plate is coated with anti-dsRNA antibody clone J2, and the standard solution or sample is added to the wells.
Biotin-labeled anti-dsRNA antibody clone J2 and peroxidase-conjugated streptavidin are then added and allowed to react.
Finally, the peroxidase remaining in the wells is reacted with TMB solution, enabling quantitative measurement of dsRNA by colorimetric detection.
- Capture antibody
- :Anti-dsRNA antibody (clone: J2)
- Detection antibody
- :Biotin-labeled anti-dsRNA antibody (clone: J2)

Kit Contents ・ Protocol
Kit Contents
| Components | Amount |
|---|---|
| Antibody-coated Plate | 96 wells (8×12) /1 plate |
| UTP dsRNA Standard | 50 μL/1 bottle |
| m1ψ dsRNA Standard | 50 μL/1 bottle |
| Sample Reaction Buffer | 25 mL/1 bottle |
| Antibody Reaction Buffer | 25 mL/1 bottle |
| Biotin-conjugated Antibody | 1 bottle |
| Peroxidase-conjugated Streptavidin Solution | 120 μL/1 bottle |
| TMB Solution | 12 mL/1 bottle |
| Stop Solution | 12 mL/1 bottle |
| Wash Solution (10×) | 100 mL/1 bottle |
| Plate Seal | 4 sheets |
Protocol
- Step 01
- Reagent preparation
Dilute the standards and wash solution included in the kit. - Step 02
- Sample preparation
Dilute samples as required.
For UTP mRNA samples, we recommend adjusting the concentration to 100 ng/mL mRNA or less. For m1ψ mRNA samples, a concentration of 500 ng/mL mRNA or less is recommended. Adjust the sample concentrations as necessary to ensure they fall within the calibration curve range. - Step 03
- Reaction procedure
① Antibody-coated plate Wash 3 times ② Sample or standard solution Add 100 μL
Approximately shake at 500 rpm, 20℃ - 25℃, incubate for 2 hours
*Preparation of biotin-conjugated antibody solution from the supplied antibody
(Dissolve in 120 μL of purified water, then dilute 100-fold with antibody reaction buffer equilibrated to room temperature.)③ Antibody-coated plate Wash 3 times ④ Biotin-conjugated antibody Solution Add 100 μL
Approximately shake at 500 rpm, 20℃ - 25℃, incubate for 1 hour⑤ Antibody-coated plate Wash 3 times ⑥ Peroxidase-conjugated streptavidin solution Add 100 μL
Approximately shake at 500 rpm, 20℃ - 25℃, incubate for 1 hour⑦ Antibody-coated plate Wash 3 times ⑧ TMB solution Add 100 μL
Approximately shake at 600 rpm for 10 seconds, repeated 3 times, then let stand, 20℃ - 25℃, Incubate for 30 minutes⑨ Stop solution Add 100 μL
Approximately shake at 600 rpm for 10 seconds, repeated 3 times - Step 04
- Absorbance measurement
Measure absorbance with a plate reader at a primary wavelength of 450 nm and a secondary wavelength of 620 nm.
Data
Effect of Nucleotide Modification and Chain Length
capture : K1 detection : K2


capture : J2 detection : K2


capture : J2 detection : J2


The detection system of this product (capture: J2; detection: biotinylated J2) was compared with combinations of other anti-dsRNA-recognizing antibody clones. UTP and m1ψ dsRNA standards were used to measure dsRNA of various chain lengths at a concentration of 1 ng/mL.
The results demonstrated that the detection system of this product exhibited the least variation in detected concentration, regardless of m1ψ modification or chain length.
Measurement of dsRNA in mRNA Solutions


Using this kit, the dsRNA concentrations in capped unmodified and m1ψ-modified mRNA solutions were measured.
The measured values were proportional to the mRNA sample concentration and showed linearity over the ranges of 20 to 100 ng/mL for unmodified mRNA and 50 to 500 ng/mL for m1ψ-modified mRNA.
Spike and Recovery Test
UTP mRNA
| Specimen | Spiked amount of dsRNA (pg/mL) |
Measurement value of dsRNA (pg/mL) |
Recovery (%) |
|---|---|---|---|
| mRNA solutions 200 ng/mL |
- | 176 | - |
| 20 | 197 | 104 | |
| 100 | 285 | 109 | |
| 500 | 637 | 92 | |
| mRNA solutions 50 ng/mL |
- | 44 | - |
| 20 | 64 | 100 | |
| 100 | 140 | 96.5 | |
| 500 | 550 | 101 |
m1ψ mRNA
| Specimen | Spiked amount of dsRNA (pg/mL) |
Measurement value of dsRNA (pg/mL) |
Recovery (%) |
|---|---|---|---|
| mRNA solutions 200 ng/mL |
- | 167 | - |
| 20 | 186 | 93 | |
| 100 | 280 | 113 | |
| 500 | 638 | 94.1 | |
| mRNA solutions 50 ng/mL |
- | 41.1 | - |
| 20 | 60 | 95.7 | |
| 100 | 145 | 104 | |
| 500 | 521 | 95.9 |
Using this kit, a spike-and-recovery test for dsRNA in mRNA solutions was performed.
The results showed high recovery of dsRNA at mRNA concentrations of 50 ng/mL and 200 ng/mL.
Measurement of dsRNA in IVT Solutions after IVT Reaction


Using two different commercially available in vitro transcription (IVT) kits (A and B), two types of mRNA, one long and one short, were synthesized.
Using this product, the dsRNA concentrations in synthesized mRNA solutions were measured.
The measured values were confirmed to be linear with respect to the mRNA sample concentration over the range of 25 to 100 ng/mL for unmodified mRNA and 125 to 500 ng/mL for m1ψ modified mRNA.
Matrix Effect of IVT Reaction Buffer

A comparison was conducted between this kit and another manufacturer’s kit to evaluate the recovery of dsRNA spiked into the IVT reaction mixture prior to synthesis.
Unlike the other manufacturer's product, this kit was not affected by the matrix and was able to measure dsRNA accurately without requiring sample dilution.
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For research use or further manufacturing use only. Not for use in diagnostic procedures.
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