Description

Rapid, Simple, Accurate Mycoplasma Detection to Anyone & Anywhere

The AdvSHENTEK 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.

For Mycoplasma cassette information, please refer to the SHENTEK® AdvSHENTEK Mycoplasma DetectInnova Cassette User Guide (Product No. 1509100).

Size: 4 system; 16 system

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

Cross reactant NO.	Resource	Cross Reactivity
1	CHO	N/A
2	Vero	N/A
3	293T	N/A
4	HEK293	N/A
5	MDCK	N/A
6	NS0	N/A
7	Sf9	N/A
8	Hi5	N/A
9	E.coli	N/A
10	Pichia pastoris	N/A
11	Saccharomyces cerevisiae	N/A
12	Hans enula polymorpha	N/A
13	Clostridium acetobutylicum	N/A
14	Clostridium perfringens	N/A
15	Clostridium sporogenes	N/A
16	Streptococcus pneumoniae	N/A
17	Streptococcus agalactiae	N/A
18	Streptococcus mutans	N/A

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.

NO	Sample Matrix	Signal
1	ExpiCHOTM	N/A
2	ExpiCHOTM(10%DMSO)	N/A
3	DMEM(10%FBS)	N/A
4	DMEM(20%FBS+10%DMSO)	N/A

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

Table 5 Matrix robustness results

Strain	Matrix	Tset Conc. (CFU/mL)	Detection rate (%)	Acceptance Criteria	Conclusion
Mycoplasma orale	CHO-S (10⁷cells/mL)	10	95.8	Detection rate at least over 95%.	Pass
Mycoplasma hyorhinis		10	100		Pass
Mycoplasma hyorhinis		10	100		Pass
Mycoplasma fermentans		10	100		Pass

AdvSHENTEK DetectInnova System SHENTEK™