AdvSHENTEK DetectInnova System

Overview - AdvSHENTEK DetectInnova System

Description

The AdvSHENTEK Mycoplasma DetectInnova System transformed RMM  (rapid microbiological method) into a streamlined, fast, fully automated, and easily portable laboratory system. It integrates nucleic acid extraction and real-time PCR assay, allowing a turn-around time of  2.5 hours from sample to result. Importantly, it only requires less than 5 minutes of hands-on time without specific DNA extraction and PCR expertise to operate.

Features

• Easy on-time testing:

Complete automation from sample to result;

Hands-on time < 5 mins;

• High Sensitivity & Efficiency:

LOD < 10 CFU/mL;

4 standardized assays in a single run;

• Accessible Anywhere &Anyone:

No PCR lab or skills required;

Seamless integration from extraction to amplification without manual intervention;

• Data Reliability:

Fully validated workflow;

Effective internal control across every stage;

21 CFR Part 11 compliance;

• High Specificity:

No cross-reactivity with different bacteria or cell lines;

No sample matrix interference;

• Comprehensive coverage:

Able to detect over 180 species of Mycoplasma, Spiroplasma and Acholeplasma;

Specificity- AdvSHENTEK DetectInnova System

2.1 Strain Coverage:

Through intensive bioinformatics analysis of the amplification targets, the detection system allows genomic DNA of nearly 200 species, including 135 species of Mycoplasma, 38 species of Spiroplasma, and 8 species of Acholeplasma.

2.2 Strain Specificity:

No cross-reactivity with Clostridium, Lactobacillus, Streptococcus, and different cell lines.

Table 3 Results of Cross-Reactivity

2.3 Matrix Specificity: No Matrix Effect in Complex

Table 4 Results of Sample Matrix Interference

List of culture media, serum, and cryoprotectants tested do not interfere with mycoplasma detection using the SHENTEK DetectInnova system.

3. Robustness: Detection Limit Less Than 10 CFU/mLin Complex Matrices

Table 5 Matrix robustness results