ISSN 1308-8734 | E-ISSN 1308-8742
Original Article
Performance Evaluation of a New Culture Colorimetric Detection Assay
1 Department of Biochemical Sciences, Catholic University “Our Lady of Good Counsel”, Tirana, Albania  
2 Department of Clinical Microbiology and Virology, Polyclinic Tor Vergata Foundation, Rome, Italy  
3 Department of Statistical Sciences, “La Sapienza” University of Rome, Rome, Italy  
4 Department of Experimental Medicine and Surgery, University of Rome “Tor Vergata”, Rome, Italy  
Eurasian J Med ; : -
DOI: 10.5152/eurasianjmed.2018.17364
Key Words: MYCO WELL D-ONE, sexually transmitted infections, colorimetric detection assay, real-time PCR
Abstract

 

Objective: To evaluate the performance of the culture colorimetric detection assay MYCO WELL D-ONE® (MWD-ONE), designed to detect sexually transmitted infections using real-time polymerase chain reaction (PCR) as a reference method.

 

Materials and Methods: One hundred and ten urogenital samples were screened for Gardnerella vaginalis (GV), Trichomonas vaginalis (TV), Mycoplasma hominis (MH), Mycoplasma spp., and Ureaplasma urealyticum (UU)/Ureaplasma parvum (UP) using the MWD-ONE and real-time PCR assays Gardnerella vaginalis/Lactobacillus species Real-TM Quant and Anyplex II STI-7 Detection, respectively.

 

Results: GV was detected in 33 samples by both the MWD-ONE and real-time PCR, while 6 samples gave discordant results. TV was detected by both MWD-ONE and Anyplex II STI-7 Detection kits in 3 samples, while 107 were negative. MH was detected by both methods in 5 cases, 4 samples gave discordant results, and 101 were negative. Mycoplasma genitalium (MG) was detected by Anyplex II STI-7 in 2 cases, 1 of which was detected as Mycoplasma spp. by MWD-ONE. Ten samples were positive by MWD-ONE, and 98 were negative with both assays. With regard to UU/UP, 24 cases were detected by MWD-ONE and Anyplex PCR, 25 by PCR only, 4 by MWD-ONE, and 57 tested negative with both methods.The positive predictive values (PPV) and negative predictive values (NPV) of the MWD-ONE assay for the pathogens tested were as following: GV, PPV 94.3%, NPV 94.7%; TV, PPV and NPV 100%; MH, PPV 71.4%, NPV 98.1%; Mycoplasma spp., PPV 9.1%, NPV 98.9%; and Ureaplasma spp., PPV 85.7 %, NPV 69.5 %. The agreement between the MWD-ONE and PCR was strong for GV and MH (k=0.8 and 0.7, respectively); perfect for TV (k=1); and moderate for UU/UP (k=0.4).

 

Conclusion: MWD-ONE assay appears to be suitable for routine testing of sexually transmitted infections.

 

Cite this article as: Favalli C, Favaro M, Santi F, Piperno M, D’Agostini C, Ciotti M. Performance Evaluation of a New Culture Colorimetric Detection Assay. Eurasian J Med 2018; 50: 10.5152/eurasianjmed.2018.17364.

 

 

 

 

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