Lioﬁlchem® MYCOPLASMA SYSTEM Plus (Ref. 72592 - 79592) Rev.6 / 11.07.2012 MYCOPLASMA SYSTEM Plus System for the detection, semi-quantitative determination and susceptibility test of urogenital mycoplasmas DESCRIPTION MYCOPLASMA SYSTEM Plus is a 24-well system containing desiccated biochemical and antibiotic substrates for the detection, susceptibility test and semi-quantitative determination of urogenital mycoplasmas. The system is inoculated with the suspension of the clinical sample and incubated at 36 ± 1 °C for 18-24 hours. The tests used in the detection, count and susceptibility test are interpreted by evaluating the color of the various wells and performing a microscope examination. KIT CONTENTS The kit contains:
20 systems MYCOPLASMA SYSTEM Plus
20 Vials di Physiological Solution (7 mL/vial)
4 systems MYCOPLASMA SYSTEM Plus
4 Vials di Physiological Solution (7 mL/vial)
ITEMS NECESSARY BUT NOT INCLUDED IN THE KIT
Vaseline oil for microbiological use (VASELINE OIL 2 bottle of 50 mL) ref. 80278
CONFIGURATION The conﬁguration of the system is shown in Table 1. Table 1 COUNT AND IDENTIFICATION OF MYCOPLASMAS / UREAPLASMAS
Growth of mycoplasmas (102 < titre < 104 CFU/mL)
Growth of mycoplasmas (104 < titre < 105 CFU/mL)
Growth of mycoplasmas (titre > 105 CFU/mL)
DETECTION OF T.VAGINALIS AND CANDIDA spp. 6-TR/YE Trichomonas vaginalis / Candida spp. SUSCEPTIBILITY TESTING OF THE MYCOPLASMAS / UREAPLASMAS
Lioﬁlchem® MYCOPLASMA SYSTEM Plus (Ref. 72592 - 79592) Rev.6 / 11.07.2012 PRINCIPLE OF THE METHOD MYCOPLASMA SYSTEM Plus allows the detection, semi-quantitative count, presumptive identiﬁcation and susceptibility test of Mycoplasma hominis and Ureaplasma urealyticum isolated from clinical samples and the detection and presumptive identiﬁcation of the microorganisms most frequently isolated from vaginal and urethral swabs and seminal ﬂuid, such as Trichomonas vaginalis and Candida spp. !
The semi-quantitative count of urogenital mycoplasmas (Mycoplasma hominis and Ureaplasma urealyticum) is provided by the yellow to red color change of wells 1-GR+, 2-GR++, 3-GR+++.
The presence of Mycoplasma hominis is shown by the yellow to red color change of the Arginine Test well 4-ADC.
The presence of Ureaplasma urealyticum is shown by the yellow to red color change of the Urea Test well 5-UR.
The presence of Trichomonas vaginalis andCandida spp. is determined by microscope (40x) examination of a drop of culture liquid taken from well 6-TR/YEevaluating the presence of mobile ciliated protozoites for identiﬁcation of Trichomonas vaginalis and/or the presence of chlamydospores and hyphae for identiﬁcation of Candida spp.
The susceptibility testing of the urogenital mycoplasmas is evaluated by observing the color change in wells 7-TE to 24-AZM as indicated in table 3. COMPOSITION
Culture medium for growth of mycoplasmas
Culture medium for growth of mycoplasmas
Culture medium for growth of mycoplasmas
Culture medium with substrate for decarboxylation of arginine
Culture medium con with substrate for hydrolysis of urea
Culture medium for isolation of Trichomonas vaginalis and Candida spp.
Culture medium containing Tetracycline - 4 μg/mL
Culture medium containing Tetracycline - 8 μg/mL
Culture medium containing Peﬂoxacin - 8 μg/mL
Culture medium containing Peﬂoxacin - 16 μg/mL
Culture medium containing Oﬂoxacin - 1 μg/mL
Culture medium containing Oﬂoxacin - 4 μg/mL
Culture medium containing Doxycycline - 4 μg/mL
Culture medium containing Doxycycline - 8 μg/mL
Culture medium containing Erythromicin - 8 μg/mL
Culture medium containing Erythromicin - 16 μg/mL
Culture medium containing Claritromycin - 8 μg/mL
Culture medium containing Claritromycin - 16 μg/mL
Culture medium containing Minociclyne - 4 μg/mL
Culture medium containing Minociclyne - 8 μg/mL
Culture medium containing Clindamycin - 4 μg/mL
Culture medium containing Clindamycin - 8 μg/mL
Culture medium containing Azithromycin - 4 μg/mL
Culture medium containing Azithromicyn - 8 μg/mL
Physiological Solution (g/L): Sodium chloride 9 g; Distilled water 1000 mL; pH 6.8 ± 0.2
Lioﬁlchem® MYCOPLASMA SYSTEM Plus (Ref. 72592 - 79592) Rev.6 / 11.07.2012 COLLECTION AND CONSERVATION OF THE SAMPLES Obtain the vaginal or urethral secretion with synthetic ﬁbre swabs. Obtain the seminal ﬂuid according to the technique envisaged for the microbiological culture examination. The samples must be sent for inoculation in the MYCOPLASMA SYSTEM Plus immediately after they are taken. Do not store in the refrigerator for even limited periods of time, since low temperatures may damage the vitality of some particularly sensitive microorganisms such as Trichomonas vaginalis prejudicing the ﬁnal result. TEST PROCEDURE PREPARATION OF THE CLINICAL SAMPLE Open one of the vials of Physiological Solution contained in the kit. VAGINAL SWAB - URETHRAL SWAB
Immerse the swab (after obtaining the clinical material) in the vial of Physiological Solution and wait 5 minutes. Carefully squeeze the swab against the vial wall so that the clinical material is dispersed homogeneously in thephysiological solution. SEMINAL LIQUID
Add 0.2 mL of sample to the vial of Physiological Solution, shake and wait 5 minutes before inoculating thesystem.
Centrifuge 20 mL of urinary sample into two 10 mL tubes. Collect from each tube 0.1 mL of urinary sediment (0.2 mL)and add to the vial of Physiological Solution contained in the kit; shake and wait 5 minutes before inoculating thesystem. CLINICAL MATERIAL FROM MYCOPLASMA TRANSPORT BROTH (ref. 20158)
Add 1 mL of Mycoplasma Transport Broth, containing the sample under examination, to the vial of PhysiologicalSolution, shake delicately and wait 5 minutes before inoculating. INOCULATION OF THE SYSTEM 1. Take a system from its wrapper and allow to come to room temperature. 2. Write down the name of the patient, the date of the start of the examination, and the type of clinical material. 3. Transfer 0.2 mL (4 drops) of suspension of the clinical sample into each well of the system. 4. Cover all the wells except 6-TR/YEwell with one drop of Vaseline oil for microbiological use. 5. Cover the system with the lid provided and incubate at 36 ± 1 °C for 18-24 hours. If the presence of Mycoplasma hominis is suspected, incubate at 36 ± 1 °C for a further 24 hours. INTERPRETATION OF THE RESULTS At the end of the incubation: !
Watch for the color change of the wells 1-GR+ to 5-UR and interpret the results using table 3 (COUNT AND IDENTIFICATION OF THE MYCOPLASMAS / UREAPLASMAS).
Take a drop of liquid from well 6-TR/YE, deposit it on a glass slide, place a cover slip on top and watch for the presence of Trichomonas vaginalis and Candida sppat the microscope (40x). Interpret as indicated in Table No. 3 (SEARCH FOR T. VAGINALIS AND CANDIDA spp).
Watch for the color change of the wells from 6-TE to 24-AZM and interpret the results using Table No. 3 (SUSCEPTIBILITY TESTING OF THE MYCOPLASMAS / UREAPLASMAS). Refer to the well no. 1-GR+ as growth control for the antibiogram of mycoplasma.
Note the results on the TEST RESULTS FORM (copy as many forms as necessary).
Lioﬁlchem® MYCOPLASMA SYSTEM Plus (Ref. 72592 - 79592) Rev.6 / 11.07.2012 Well colour COUNT AND IDENTIFICATION OF MICOPLASMAS / UREAPLASMAS Negative Positive reaction reaction
Growth of mycoplasmas (102 < titre < 104 CFU/mL) (1)
Growth of mycoplasmas (104 < titre < 105 CFU/mL) (2)
Growth of mycoplasmas (titre > 105 CFU/mL) (3)
Arginine Test: identiﬁes Mycoplasma hominis
Urea Test: identiﬁes Ureaplasma urealyticumDETECTION OF T. VAGINALIS AND CANDIDA spp. Microscopic observation (40x) T. vaginalis: mobile ciliated trophozoite
Trichomonas vaginalis / Candida spp. Candida spp: chlamydospores and hyphae
SUSCEPTIBILITY TEST OF Well colour MYCOPLASMAS / UREAPLASMAS S = Sensitive I = Intermediate sensitivity R = Resistant LEGEND (1) = equivalent to 5-20 colonies grown on Mycoplasma Agar A7 (2) = equivalent to 20-50 colonies grown on Mycoplasma Agar A7 (3) = over 50 colonies grown on Mycoplasma Agar A7
Lioﬁlchem® MYCOPLASMA SYSTEM Plus (Ref. 72592 - 79592) Rev.6 / 11.07.2012 QUALITY CONTROL Every batch of MYCOPLASMA SYSTEM Plus is subjected to quality control using the following reference microorganisms: FACTORS THAT MAY INVALIDATE THE RESULTS Poor standardisation of the inoculum; application of the method to microorganisms not in the Mycoplasma group; use of expired systems and/or reagents; incorrect application of the technique; non compliance with temperatures and times of incubation. LIMITS AND WARNINGS The quality of the collecting inﬂuences the test result. A negative test, therefore, is not always index of absence of infection. A positive test obtained with the system MYCOPLASMA SYSTEM Plus indicates an urogenital mycoplasmas infection, but it cannot be used, alone, to make a clinical diagnosis. PERFORMANCE The results obtained with MYCOPLASMA SYSTEM Plus agree with those obtained using traditional culture methods. Application of the Wilcoxon non parametric statistical test shows that for each clinical material, the groups of standard values and those obtained with MYCOPLASMA SYSTEM Plus do not differ signiﬁcantly P ≤ 0.05 (1). PRECAUTIONS The product MYCOPLASMA SYSTEM Plus is not classiﬁed as hazardous under current legislation, however see the safety data sheet for a correct use. MYCOPLASMA SYSTEM Plus is a disposable device to be used only for diagnostic use in vitro. It must be used in the laboratory by properly trained personnel, using approved aseptic and safety methods for handling pathogenic agents. STORAGE Store at 2-8 °C in the original packaging. Keep away from sources of heat and avoid excessive changes in temperature. In such conditions, the product will remain valid until the expiry date indicated on the label. Do not use beyond that date. Eliminate without using if there are signs of deterioration. DISPOSAL OF USED MATERIAL After use, MYCOPLASMA SYSTEM Plus and material that has come into contact with the sample must be decontaminated and disposed of in accordance with the techniques used in the laboratory for decontamination and disposal of potentially infected material. PRESENTATION Packaging MYCOPLASMA SYSTEM Plus MYCOPLASMA SYSTEM Plus TABLE OF SYMBOLS
EQUITIES FIXED INCOME REAL ESTATE LIQUIDITY ALTERNATIVES BLACKROCK SOLUTIONSsociété d’investissement à capital variable (SICAV) LuxemburgoR.C.S. Luxemburgo, sección B número 127481société d’investissement à capital variable (SICAV)R.C.S. Luxemburgo, sección B número 127481Estatutos Refundidos de 2 de mayo de 2007operaciones considere convenientes para la realización ydesarroll
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