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AdvSHENTEK® Mycoplasma DetectInnova System

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    AdvSHENTEK DetectInnova System (HubbleTM)


    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.

    Dimension: 380mm × 305mm × 343mm   

    Weight: 19kg


    Rapid, Simple, Accurate Mycoplasma Detection to Anyone & Anywhere

    Step 1

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    Step 3


    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;

    Performance Characteristics

    Limit of Detection

    Eight mycoplasma strains at 10 CFU/mL and three mycoplasma strains at 5 CFU/mL were tested. For each strain, 24 assays were conducted and the detection rate was calculated. The results are summarized in the table below.

    Strains Test Conc. (CFU/mL) Detection rate (%) Acceptance Criteria Conclusion
    Mycoplasma orale 10 100 Detection rate at least above 95%. Pass
    Mycoplasma pneumoniae 10 100 Pass
    Mycoplasma hyorhinis 10 100 Pass
    Mycoplasma hominis 10 95.8 Pass
    Mycoplasma fermentans 10 100 Pass
    Acholeplasma laidlawii 10 100 Pass
    Mycoplasma salivarium 10 100 Pass
    Spiroplasma citri 10 100 Pass
    Mycoplasma gallisepticum 10 100 Pass
    Mycoplasma arginini 10 100 Pass
    Mycoplasma synoviae 10 100 Pass

    Specificity

    Eighteen genomic DNAs from engineered cells and bacteria, were extracted, purified and tested with the cassette. All test results were negative.

    Types of interference Species Results
    Natural bacteria 1. Clostridium (Clostridium acetobutylicum, Clostridium perfringens, Clostridium sporogenes);
    2. Streptococcus (Streptococcus pneumoniae, Streptococcus agalactiae, Streptococcus mutans).
    Negative
    Engineered cells CHO, Vero, 293T, HEK293, MDCK, Sf9, Hi5, NS0 Negative
    Engineered bacteria 1. Escherichia coli,
    2. Pichia pastoris,
    3. Hansenula polymorpha,
    4. Saccharomyces cerevisiae.
    100

    Reproducibility

    Eighteen genomic DNAs from engineered cells and bacteria, were extracted, purified and tested with the cassette. All test results were negative.

    Instrument precision

    Mycoplasma orale 100 CFU was tested on three different instruments by three analysts, with four replicates per instrument. All 12 samples were successfully detected, and both the Ct values of the samples and internal controls met the requirement of CV ≤ 15%.


    Repeatability

    Twelve assays were performed on Mycoplasma orale (100 CFU) by a single operator using the same instrument. All tests were successfully detected, and both the Ct values of the samples and the internal controls can meet the requirement of CV ≤ 15%.


    Case Study​

    Sample Types Sample Details Methods Sample Volume M. orale/M. hyorhinis/M. pneumoniae (10 cfu)
    Culture Media DMEM Assay 1mL 24/24
    DMEM(10% FBS) 24/24
    DMEM(20% FBS+10% DMSO) 24/24
    Cryostor CS10 24/24
    PBS 24/24
    ExpiCHO 24/24
    Cell therapy product Jurkat Cell line 10^6-10^7 Pre-treatment + Assay 1mL 24/24
    Jurkat Cell line 10^8 (5% DMSO+5% HBS) 24/24
    TILs 10^6-10^7 24/24
    CD19 CAR-T 2.0 × 10^6 200uL-1mL 24/24
    BCMA CAR-T 10^7 24/24
    IIT samples (10^6-5x10^7 cells) 24/24
    Fresh CAR-T (10^5-10^6 cells) Assay 100uL 24/24