Comparison of Anyplex II STI-7 assay to the Allplex™ CT/NG ...
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Comparison of Anyplex™ II STI-7 assay to the Allplex™ CT/NG/MG/TV Assay for the detection of sexually transmitted infections from urine specimens collected with UriSwab™ Anna Archenti 2 , Patrizia Biagiola 2 , Debora Pasquali 2 , Marina Foti 2 , Santina Castriciano 1 2 ATS Città Metropolitana di Milano-Laboratorio di Prevenzione, 1 Copan Italia Spa, Brescia Italy Conclusions In this study an excellent agreement was demonstrated between Seegene Anyplex™II STI-7e v1.1 and by Allplex™ CT/NG/MG/TV assays for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium in urine samples collected with Copan UriSponge™. The new Seegene Allplex™ CT/NG/MG/TV assay eliminates the detection of MH, UU, and UP, included in the STI-7, that may be present in colonized patients. Furthermore Copan UriSponge™ proved to be an excellent device for the collection and transport of urine samples for STI detection with molecular assays and can be used for culturing all the Neisseria gonorrhoeae positive urine samples for antimicrobial resistance testing. Background Sexual transmitted infections are playing an important role in genital infections. Chlamydia trachomatis (CT) Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV), have been associated vaginal infections, cervicitis and urethritis that can lead to complications like pelvic inflammatory diseases, ectopic pregnancy and infertility. Other pathogens like Mycoplasma hominis (MH), Ureaplasma urealyticum (UU) and Ureaplasma parvum (UP) are residing in the genital tracts but are not always associated to active infections. Seegene introduced the new Allplex™ CT/NG/MG/TV Assay for sexual transmitted infections detection. Objective The objective of this study was to compare the performance of the Anyplex™II STI-7e v1.1 assay that detects CT, NG, TV), MG, MH, UU), and UP, to the Allplex™ CT/NG/MG/TV Assay for the detection of STI from urines samples Materials Methods In this study were used 201 Urine samples collected from patients attending an STD clinic in Milan. A first catch urine was collected in a sterile cap, the UriSponge TM (Copan Italia, Brescia, Italy) was immersed into the urine until the sponges were saturated and stored back in its own tube. Prior testing, UriSponge TM samples were centrifuged at 3000 RPM for 10 minutes, after de-capping the tubes, discarding the sponges and reducing the urine volume to 2 ml, the urine samples were vortexed and loaded on the Nimbus and 200 ul of urine was used for nucleic acids extraction. Nucleic acids were analyzed with the STI-7e and CT/NG/MG/TV assays on the CFX96 (Bio-Rad) real-time PCR detection system. Results from both assays were compared, concordant results were considered negative or positive, discordant results were retested in duplicate. Results In the 201 urine samples tested STI-7e detected 31 negative and 170 positive while CT/NG/MG/TV detected 94 negative and 107 positive samples (Graph 1). When comparing the positive results: STI-7e detected 1 NG and 1 MG positive not detected by CT/NG/MG/TV while CT/NG/MG/TV detected 1 CT and 1 NG missed by STI-7e . Results were not statistically significant (p>0.05). Anyplex II STI-7e detected additional 36 MH, 46 UP and 39 UU not included in the Allplex™ CT/NG/MG/TV assay. UriSponge TM Sponge Electronic Microscopy image containing salts Santina Castriciano: [email protected] Seegene nucleic acids extraction and real-time PCR detection system. POSTER P038 31 94 170 107 0 20 40 60 80 100 120 140 160 180 STI7e CT/NG/MG/TV Urine samples Graph 1: Total positive and negative results Negative positive 58 38 21 6 36 46 39 59 37 20 6 0 10 20 30 40 50 60 70 CT NG MG TV MH UP UU Urine samples Graph 2: STI detected in Urine samples by Seegene STI 7e and CT/NG/MG/TV assays. STI 7e CT/NG/MG/TV UriSponge TM collection procedure Scan QR Code to download the digital version of this poster.
Transcript of Comparison of Anyplex II STI-7 assay to the Allplex™ CT/NG ...
Comparison of Anyplex™ II STI-7 assay to the Allplex™ CT/NG/MG/TV Assay for the detection
of sexually transmitted infections from urinespecimens collected with UriSwab™
Anna Archenti2, Patrizia Biagiola2, Debora Pasquali2, Marina Foti2, Santina Castriciano1
2ATS Città Metropolitana di Milano-Laboratorio di Prevenzione, 1Copan Italia Spa, Brescia Italy
ConclusionsIn this study an excellent agreement was demonstratedbetween Seegene Anyplex™II STI-7e v1.1 and by Allplex™CT/NG/MG/TV assays for the detection of Chlamydiatrachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium inurine samples collected with Copan UriSponge™.
The new Seegene Allplex™ CT/NG/MG/TV assay eliminates thedetection of MH, UU, and UP, included in the STI-7, that maybe present in colonized patients.
Furthermore Copan UriSponge™ proved to be an excellentdevice for the collection and transport of urine samples for STIdetection with molecular assays and can be used for culturingall the Neisseria gonorrhoeae positive urine samples forantimicrobial resistance testing.
BackgroundSexual transmitted infections are playing an important role ingenital infections. Chlamydia trachomatis (CT) Neisseriagonorrhoeae (NG), Mycoplasma genitalium (MG) andTrichomonas vaginalis (TV), have been associated vaginalinfections, cervicitis and urethritis that can lead tocomplications like pelvic inflammatory diseases, ectopicpregnancy and infertility. Other pathogens like Mycoplasmahominis (MH), Ureaplasma urealyticum (UU) and Ureaplasmaparvum (UP) are residing in the genital tracts but are notalways associated to active infections. Seegene introduced thenew Allplex™ CT/NG/MG/TV Assay for sexual transmittedinfections detection.
ObjectiveThe objective of this study was to compare the performance ofthe Anyplex™II STI-7e v1.1 assay that detects CT, NG, TV),MG, MH, UU), and UP, to the Allplex™ CT/NG/MG/TV Assay forthe detection of STI from urines samples
Materials
Methods In this study were used 201 Urine samples collected frompatients attending an STD clinic in Milan.A first catch urine was collected in a sterile cap, theUriSpongeTM (Copan Italia, Brescia, Italy) was immersed intothe urine until the sponges were saturated and stored back inits own tube.Prior testing, UriSpongeTM samples were centrifuged at 3000RPM for 10 minutes, after de-capping the tubes, discarding thesponges and reducing the urine volume to 2 ml, the urinesamples were vortexed and loaded on the Nimbus and 200 ulof urine was used for nucleic acids extraction.Nucleic acids were analyzed with the STI-7e and CT/NG/MG/TVassays on the CFX96 (Bio-Rad) real-time PCR detection system.Results from both assays were compared, concordant resultswere considered negative or positive, discordant results wereretested in duplicate.
ResultsIn the 201 urine samples tested STI-7e detected 31 negativeand 170 positive while CT/NG/MG/TV detected 94 negativeand 107 positive samples (Graph 1).When comparing the positive results: STI-7e detected 1 NGand 1 MG positive not detected by CT/NG/MG/TV whileCT/NG/MG/TV detected 1 CT and 1 NG missed by STI-7e .Results were not statistically significant (p>0.05). Anyplex IISTI-7e detected additional 36 MH, 46 UP and 39 UU notincluded in the Allplex™ CT/NG/MG/TV assay.
UriSpongeTM
Sponge Electronic Microscopy imagecontaining salts
Santina Castriciano: [email protected]
Seegene nucleic acids extraction and real-time PCR detection system.
POSTER P038
31
94
170
107
020406080
100120140160180
STI7e CT/NG/MG/TVUrine samples
Graph 1: Total positive and negative results
Negativepositive
58
38
21
6
36
46
39
59
37
20
6
0
10
20
30
40
50
60
70
CT NG MG TV MH UP UUUrine samples
Graph 2: STI detected in Urine samples by Seegene STI 7e and CT/NG/MG/TV assays.
STI 7eCT/NG/MG/TV
UriSpongeTM collection procedure
Scan QR Code to downloadthe digital version of this poster.
