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GeneProof Team
myCROBE® line
On this page you will find order codes, technical specifications and documents for the selected product.
| Product name | Catalog no. | Technology | Packaging |
| GeneProof Herpes Simplex Virus (HSV-1/2) MC PCR Kit | HSV/MC/205 | PCR | for 180 quantitative tests |
| Indication | in vitro diagnostic medical device | |
| Regulatory Status | CE IVD / EC Directive 98/79/EC | |
| Intended User | For professional use in laboratories with trained staff | |
| Test Principle | Real-time polymerase chain reaction (PCR) | |
| Type of Analysis | Qualitative and quantitative | |
| Automated / Manual detection | Automated | |
| Target sequence | Gene encoding B glycoprotein (gB) | |
| Analytical Specificity | Herpes Simplex Virus type 1 (HSV-1), 100 %; Herpes Simplex Virus type 2 (HSV-2), 100 % | |
| Analytical Sensitivity (LoD with 95% Probability) | HSV-1: 264.97 IU/ml HSV-2: 143.91 IU/ml |
|
| Linear Range | 109 – 103 IU/ml with precision of ± 0.5 log | |
| Dynamic Range | HSV-1: 109 – 264.97 IU/ml HSV-2: 109 – 143.91 IU/ml |
|
| Trueness | HSV-1: 0.00 log (CI95%: -0.05 – 0.06) of expected concentration HSV-2: -0.01 log (CI95%: -0.08 – 0.06) of expected concentration |
|
| Precision - repeatability | • Intra-assay HSV-1: SD of log concentration = 0.083 (CI95%: 0.056 – 0.159) HSV-2: SD of log concentration = 0.106 (CI95%: 0.072 – 0.203) |
|
| Precision - reproducibility | • Inter-assay HSV-1: SD of log concentration = 0.092 (CI95%: 0.048 – 0.574) HSV-2: SD of log concentration = 0.103 (CI95%: 0.053 – 0.642) • Inter-device HSV-1: SD of log concentration = 0.247 (CI95%: 0.129 – 1.548) HSV-2: SD of log concentration = 0.164 (CI95%: 0.086 – 1.029) • Total HSV-1: SD of log concentration = 0.225 (CI95%: 0.117 – 1.407) HSV-2: SD of log concentration = 0.142 (CI95%: 0.047 – 0.889) |
|
| Reporting Units | IU/ml | |
| Metrological Traceability | 1st WHO International Standard for Herpes Simplex Virus type-1 and type-2 (HSV-1 and HSV-2) DNA Nucleic Acid Amplification Techniques: NIBSC HSV-1 DNA 16/368 NIBSC HSV-2 DNA 17/122 |
|
| Extraction/Inhibition Control |
myCROBE Universal Internal Control |
|
| Validated Specimen | Plasma, CSF, urine, swab, whole blood (EDTA) | |
| Storage | -20 ± 5 °C | |
| Validated Extraction Methods | myCROBE/croBEE 2.0 Universal Extraction Kit | |
| Instruments |
myCROBE® Fully Automated Instrument |
|
| Detection Channels | FAM (HSV-1), Cy5 (HSV-2), HEX (Internal control) | |
| 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…
