MICA Software™

MICA Software

Not your typical PCR software

One Software For All Your Diagnostic Tests

No other software can analyze tests from different instruments and different manufacturers

Our cloud-based software provides one interface to analyze multiple tests for multiple pathogens from multiple instruments, across manufacturers

Enabled by an innovative signal processing algorithm that improves Ct calls without manually setting baselines and Ct thresholds

Applies test-specific interpretation rules

Secure and Encrypted

Avoids delays from local installation and maintenance updates

MICA Software™ Performance

Reduce errors up to 97% compared to IVD instrument software

Analysis *

Metric **

Instrument Software (Default Settings)

MICA Signal Processing Algorithm

Qualitative

Error Rate

30.6%

0.7%

97% Reduction!

Qualitative

Accuracy

69.4%

99.3%

Quantitative

Adjusted R²

0.4

0.9

Problem: Default instrument software settings have poor performance.

Current Solution: Users manually optimize baseline and C^t thresholds for every target on every PCR plate.

MICA Software™: Automated analysis has similar performance to expert manual analysis.

Users no longer need to manually adjust baselines and Ct thresholds.
* The CDC Flu SC2 Assay was performed on an ABI 7500 Fast Dx instrument, using SDS instrument software.
** Performance was compared to the gold-standard expert manual analysis.

Input File

Signal Processing
Algorithm

Apply Test-Specific
Interpretation Rules

Output

Improved Signal Processing Algorithm

Reduce errors 97% compared to instrument software.

FALSE POSITIVE

TRUE NEGATIVE

MICA Software™ Applies Test-Specific Interpretation Rules

MICA Software™ implements complex interpretation rules for each clinical test. MICA Software™ supports PCR tests and isothermal tests like MICA–Standard™ Test Kit (shown below).

Output: Results Table

Individual Samples

Plate Controls

Interpretation

Were the SARS CoV-2
N gene or Orf1ab gene detected

Was the Spike-in Control (SIC) detected?

Positive and Negative Plate Controls

Is the result Valid or Inconclusive?

If valid, was SARS CoV-2 detected or not detected?

Sample ID

SARS CoV-2 Time to Amplification (minutes)

CoV-2 Reaction Status

Extraction Control Time to Amplification (minutes)

Extraction Control Reaction Status

Plate Control (NTC)

Plate Control (CTC)

Interpretation

Sample Validity

SARS CoV-2 Result

Sample_1

17.0

Positive

20.0

Positive

Negative

Positive

Valid

SARS CoV-2 detected

Sample_2

19.0

Positive

20.2

Positive

Negative

Positive

Valid

SARS CoV-2 detected

Sample_3

Negative

20.8

Positive

Negative

Positive

Valid

SARS CoV-2 NOT Detected

Sample_4

16.2

Positive

22.2

Positive

Negative

Positive

Valid

SARS CoV-2 detected

MICA Software™ output for MICA–Standard™ Test Kits. Output differs when MICA Software™ is used to analyze other clinical tests, including PCR tests and MICA–High Throughput™ Test Kits

Intended Use for MICA Software™

MICA Software is intended for the analysis of specimens and controls from compatible nucleic acid amplification tests (NAAT). MICA Software analyzes and interprets NAAT Test results. MICA Software is deployed on a cloud-based infrastructure and accessed through a secure portal.

MICA Software is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in general PCR and in vitro diagnostic procedures.

Improved Signal Processing Algorithm

Test: CDC Flu SC2 Multiplex Assay (3 Multiplex Targets: SARS-CoV-2, Flu A, and Flu B)

Instrument: ABI 7500 Fast Dx with SDS Software v1.4.1

The gold-standard expert analysis included 12 Manually Optimized Ct Thresholds (3 Targets Per Plate, 4 PCR Plates)

Disclaimers

For In Vitro Diagnostic Use. Available in selected countries.

Customers are responsible for compliance with regulatory requirements that pertain to their procedures, use of IVD products and reporting results to relevant health authorities.

European Community Authorized Representative: MT Promedt Consulting GmbH, Altenhofstr. 80 66386 St. Ingbert Germany. Tel: +49 6894 581020