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AgPlus Diagnostics

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Our COMBINED Technology Platform

Technology

The AgPlus platform consists of an assay test cartridge and our handheld Agilis Reader for delivering rapid, quantitative diagnostic results. Our assays are developed as a two-step, single use test that simply requires the addition of the sample on to the cartridge. The assay is then inserted into The Agilis Reader for the analyte measurement and analysis to take place.

Read more about our Agilis Reader here.

Our Assay Chemistry

At the core of the AgPlus technology are the reagents for the electrochemical immunoassay. The assay chemistry utilizes silver nanoparticles as its signaling system, which brings greater benefit as detection limits are much improved while sample volumes required for analysis are reduced.

The analyte capture method is based on an “immune complex” being formed in exactly the same manner as in any immunoassay. These reduced sample volumes alongside the improved detection limits has allowed for easier miniaturisation of the system, while giving fully quantitative sample analysis. It is this basic feature that makes the AgPlus technology so universally adaptable.

How The Technology Works

The silver nanoparticles form a charged aggregate due to the presence of ammonium thiocyanate. This is attracted to the electrode under a positive potential. The silver nanoparticle at the electrode is converted to silver ions. The silver ions are measured electro-analytically giving rise to a measurable peak, the area of the peak is proportional to the concentration of molecule being measured.

Magnetic beads and silver nanoparticles are coated with a monoclonal (or polyclonal) antibody against the target analyte. The sample is mixed with the antibody-coated particles and incubated during which time complexes form. After incubation, magnets are activated in the test strip that pulls the complexes formed away from the reaction chamber and the unwanted materials within the incubation chamber to the measurement zone. Once in the measurement area, the silver nanoparticles are cleaved, drawn down to the sensor and measured. The amount of silver particles is directly proportional to the amount of analyte in the sample.

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SAMPLE TECHNICAL DATA

Standard curve and QC for Calprotectin assay in Agilis™ platform

Input Data

ELISA/Agilis comparison for Calprotectin in stool samples a marker for Inflammatory Bowel Disease (IBD)

STD point Nominal Concentration ng/mL Achieved Concentration ng/mL %RE Absolute %RE
Standard1 2 2.213 9.6 9.62
Standard2 4 3.525 -13.5 13.48
Standard3 8 9.025 11.4 11.36
Standard4 16 14.623 -9.4 9.41
Standard5 32 36.06 11.3 11.26
Standard6 64 59.363 -7.8 7.81
Standard7 128 137.8 7.1 7.11
Standard8 256 227.55 -12.5 12.5
    Mean of Absolute RE   10.32
QC Level Inassay Nominal Concentration ng/mL Nominal Concentration µg/g Back calculated concentration ng/mL Reported Calprotectin Concentration µg/g %RE
Low 6 60 8.7 87.26 31.2
Mid 22.6 226 33 330.4 31.6
High 192 1920 343.8 3438 44.2

Output Data

ELISA/Agilis comparison for Calprotectin in stool samples a marker for Inflammatory Bowel Disease (IBD)

Correlation of ELISA vs AgPlus Platform in detecting feacal calprotectin

Input Data

Correlation of ELISA vs AgPlus Platform in detecting feacal calprotectin

Patient ID Inassay concentration AgPlus (including DF) ng/mL AgPlus reported concentration µg/g ELISA reported concentration µg/g %RE
1 561 56.1 50.1 10.7
2 1499 149.9 64.2 57.2
3 1578 157.8 215.8 -36.8
4 2633 263.3 216 18
5 1941 194.1 136 29.9
6 28.77 2.877 18.3 -536.1
7 280.2 28.02 15.9 43.3
8 54.02 5.402 20.6 -281.3
9 4383 438.3 521.1 -18.9
10 2088 208.8 165 21
11 650.9 65.09 28.2 56.7
12 974.6 97.46 68.3 29.9
13 776.5 77.65 78.6 -1.2
14 16090 1609 1885 -17.2
15 - 0 6.8 -
16 3907 390.7 408 -4.4
17 1759 175.9 197.1 -12.1
18 1362 136.2 142.5 -4.6
19 37.83 3.783 20.9 -452.5
20 - 0 4.8 -

Output Data

Correlation of ELISA vs AgPlus Platform in detecting feacal calprotectin

Key Partner STI Case Study

Development & Manufacture

With the help of key partner STI, we will deliver a rapid, ultra-sensitive, fully quantitative Point of Care testing system that will have a wide range of uses both within clinical and non-clinical applications.