IVD POCT/Mycoplasm & Drug Susceptibility Test /.

Specifications

1. Diagnostic test kit
2. High sensitivity and specificity
3. Test card reading and analysis all in one
4. ISO9001. ISO13485 certified
5. Easy operation
6. OEM accepted

 Mycoplasma ID/AST Kit Series

Features

1. One-step synchronous detection:

 Mycoplasma infection type.

 Mycoplasma infectiosity.

 Mycoplasma antibiotic susceptibility.

2.  Rapid.  

Culture, interpretation and susceptibility are completed synchronously.

 3. Accurate.   

Simple operation, distinct coloration and accurate results.

 4. Stable.

Very small batch deviation. Preservable over one year in 2-8 degree.

 Principles

The Ureaplasma Urealyticums and Mycoplasma Humenis don’t have cell wall. The antibiotics are added to inhibit other microorganism growing and the nutrient is added to boost mycoplasma growing rapidly and abundantly. Ureaplasma Urealyticums and Mycoplasma Humenis can utilize substrate to produce alkalescence which makes the indicators in broth change from yellow to red and denote whether the mycoplsamas are growing. Ureaplasma Urealyticums and Mycoplasma Humenis in the test board have different susceptibility to various antibiotics and the growth peaks occur from 18 to 24, 36 to 48 hours respectively.The susceptibility will guide the doctors’ prescribing.  

Mycoplasma Test Kit Series

1.  Mycoplasma Test Kit for isolation, interpretation and antibiotic susceptibility test. 

    Identification of Mycoplasma and its Antibiotic Susceptibility against 10 Antibiotics.

2.  Mycoplasma Test Kit for interpretation and antibiotic susceptibility test.

    Interpretion of Mycoplasma and its Antibiotic Susceptibility against 12 Antibiotics.

3. The Ureaplasma Urealyticums Isolation and Culture Kit.
    Interpreting whether the Patients are infected with Ureaplasma Urealyticumss.

4.  Mycoplasma Humenis Culture Kit.

    Interpreting whether the Patients are infected with Huma Mycoplasma.

5. The Ureaplasma Urealyticums / Mycoplasma Humenis Culture Kit.

    Interpreting whether the patients are infected with Ureaplasma Urealyticums / Huma Mycoplasma.

APPLICATION

For the isolation, identification, enumeration and antibiotic susceptibility tests of urogenital tract

Ureaplasma Urealyticum (UU) and Mycoplasma Hominis (MH) in one step.

MAIN COMPONENTS

1) Susceptibility test board: 20 pcs

2) Sterile pipette tip: 20 pcs

3) Sterile paraffin oil: 2 bottles

4) Sterile diluting liquid: 2 bottles

5) Instruction: 1 pcs

6) Report booklet: 1 pcs

STORAGE AND PERIOD OF VALIDITY Stored at 2-8°C ; 12 months. SUSCEPTIBILITY FOR TEST

1) 10-antibiotic: Doxycycline (DOX), Minomyclin (MIN), Ciprofloxacin (CPF), Ofloxacin (OFL), Sparfloxacin (SPA), Roxithromycin (ROX), Azithromycin (AZI), Clarithromycin (CLA), Josamycin (JOS), Spectinomycin (SPE).

2) 12-antibiotic: Doxycycline (DOX), Minomyclin (MIN), Ciprofloxacin (CPF), Ofloxacin (OFL),

Sparfloxacin (SPA), Roxithromycin (ROX), Azithromycin (AZI), Clarithromycin (CLA), Josamycin

(JOS), Spectinomycin (SPE), Acetylspiramycin (ASP), Levofloxacin (LEV). 

SAMPLE REQUIREMENTS

Male: Urethral secretions, prostatic fluid, semen or urine sediment (Urine 10ml centrifugated at 2000 rpm for 10 minutes);

Female: Secretion from cervix opening or the amniotic fluid collected with vaginal speculum.

Or: 30-50μl freshly cultured positive broth.

SUCCESSIVE OPERATING PROCEDURES

1) Take one urea-arginine broth (freeze-dried) vial, add sterile diluent to the scale line (3.5ml), and shake well;

2) Negative control test. Take one test board, draw 100μl diluted broth (no including any sample) with sterile pipette into A1 negative well;

3) Sample inoculation. Immerce the sample swab into the broth, stir and mix with the broth thoroughly, discard cotton swabs. For the positive cultured broth, just add 30-50μl into the broth vial. After adding samples, fully mix with shake;

4) Add 100μl suspension to the rest wells;

5) Sealing wells. Add 1-2 drops aseptic paraffin oil to all wells (Note: Be sure to fully cover each well's broth surface. Otherwise broth evaporation causes incorrect results.);

6) Culture. Cover and put the test board in an incubator, culture at 35-37°C and observe the results

within 24 or 48 hours.

RESULTS EXPLANATION

1) Identification and enumeration: Observe and keep the result of Ureaplasma Urealyticum (UU) after

24 hours; Observe and keep the result of Mycoplasma Hominis (MH) after 48 hours. The results are shown for example:

2) Antibiotic Susceptibility: Wells of line A contains antibiotics in lower concentration, while line B

higher. Wells A to B, one by one contains the same antibiotic. The results are shown for example:

 PERFORMANCE CHARACTERISTICS

Broth pH: 6.0 ± 0.5 (25°C ); Repetition rate: 100%; Compliance rate: ≥ 90%; Specificity: 100%;

Intra batch discrepancy: ≤ 10%; Inter batch discrepancy: ≤ 5 %; Broth should be sterile and clear. CAUTIONS

1) The following tests are not recommended such for cases as threatened abortion, menstrual period, after vaginal medication or douche;

2) The product is for in vitro diagnostic use only;

3) The product is for single time use only;

4) The waste should be disposed after disinfection.

        Lituo Biotech is a national hi-tech enterprise specializing in R&D, production and marketing of high-quality in-vitro diagnostic reagents and clinical laboratory instruments for more than 10 years. It now possesses two subsidiaries: Zhuhai Lituo Development Co., Ltd., Hunan Lituo Biotechnology Co., Ltd.

       Benefiting from its high level R&D teams, high investment of scientific research and efficient R&D management system, Lituo Biotech has developed 7 series, nearly 30 products including stool routine examination, biochemical analysis and vaginitis detection., etc. 

        Today, Lituo Biotech has established national sales network and expanded to all over the word. We sincere wish to build up long term business relationship and friendship with you.