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GeneProof Neisseria gonorrhoeae MC PCR Kit

CE IVD myCROBE® line

On this page you will find order codestechnical specifications and documents for the selected product.

Order information

Product name Catalog no. Technology Packaging
GeneProof Neisseria gonorrhoeae MC PCR Kit NG/MC/190 PCR for 180 quantitative tests

EQA Panels

EQA results

; GP_MC_NG_QCMD_05_22_EN
pdf, [122.1 kB]
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Technical specification

Indication in vitro diagnostic medical device
Regulatory Status  CE IVD 
Intended User For professional use in laboratories with trained staff
Test Principle Real-time polymerase chain reaction (PCR)
Type of Analysis Qualitative
Automated / Manual detection Automated
Target sequence Multi-copy sequence of the gene encoding 16S rRNA and porA pseudogene
Analytical Specificity Neisseria gonorrhoeae, including mutants in porA pseudogene, 100 %
Analytical Sensitivity (LoD with 95% Probability)
Sensitivity Material Culture Quantified by
630.05 cp/ml swab CCM 4500 Neisseria gonorrhoeae Amplirun® Neisseria gonorrhoeae DNA control, Vircell
268.8 cp/ml urine CCM 4500 Neisseria gonorrhoeae Amplirun® Neisseria gonorrhoeae DNA control, Vircell
Extraction/Inhibition Control

myCROBE Universal Internal Control

Validated Specimen Swab, urine, sperm
Storage -20 ± 5 °C
Validated Extraction Methods myCROBE/croBEE 2.0 Universal Extraction Kit
Instruments

myCROBE® Fully Automated Instrument

Detection Channels FAM (NG), HEX (IC)
External Quality Assessment Regularly tested in QCMD External Quality Assessment Panels - results at www.geneproof.com

Documentation

Instruction for Use

; GP_MC_NG_Instruction_for_Use_EN
pdf, [270.93 kB]

Declaration of Conformity

; GP_MC_NG_Declaration_of_Conformity_EN
pdf, [570.08 kB]
Files are available only for registered users.

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