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GeneProof Team
PCR Kit detects and distinguishes the important STI pathogens in a single reaction tube:
Mycoplasma hominis
Ureaplasma urealyticum
Ureaplasma parvum
Product name | Catalog no. | Technology | Packaging |
GeneProof MH/UU/UP Multiplex PCR Kit | MUPX/GP/025 | real-time PCR | 25 reactions |
GeneProof MH/UU/UP Multiplex PCR Kit | MUPX/GP/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device |
Regulatory Status | CE IVD |
Intended User | For professional use in laboratories with trained staff |
Technology | Real-time PCR |
Type of Analysis | Qualitative |
Target Sequence | gap gene (M. hominis) UreD gene (U. urealyticum, U. parvum) |
Analytical Specificity | Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum, 100 % |
Analytical Sensitivity (LoD with 95% probability) |
0.84 cp/μl (on Amplirun® Mycoplasma hominis DNA control, Vircell) |
Diagnostic Specificity | 96.00 % (CI95%: 87.97 % - 98.96 %) Mycoplasma hominis 98.67 % (CI95%: 91.79 % - 99.93 %) Ureaplasma urealyticum 100.00 % (CI95 %: 92.13% - 100.00 %) Ureaplasma parvum |
Diagnostic Sensitivity | 87.50 % (CI95 %: 60.41% - 97.80 %) Mycoplasma hominis 93.75 % (CI95 %: 67.71% - 99.67 %) Ureaplasma urealyticum 100.00 % (CI95 %: 87.36% - 100.00 %) Ureaplasma parvum |
Positive Predictive Value | 82.35 % (CI95%: 55.80 % - 95.33 %) Mycoplasma hominis 93.75 % (CI95%: 67.71 % - 99.67 %) Ureaplasma urealyticum 100.00 % (CI95%: 87.36 % - 100.00 %) Ureaplasma parvum |
Negative Predictive Value | 97.30 % (CI95%: 89.69 % - 99.53 %) Mycoplasma hominis 98.67 % (CI95%: 91.79 % - 99.93 %) Ureaplasma urealyticum 100.00 % (CI95%: 92.13 % - 100.00 %) Ureaplasma parvum |
Extraction/Inhibition Control |
PCR inhibition and DNA extraction efficiency control |
Validated Specimen | Swab, urine, transport medium: UTM® Viral Transport (COPAN Diagnostics Inc.) |
Storage | -20 ± 5 °C |
Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
Instruments |
croBEE Real-Time PCR System |
Required Detection Channels | FAM, HEX, Cy5, Texas Red |
External Quality Assessment | Regularly tested in QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com |
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GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…