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GeneProof Herpes Simplex Virus (HSV-1/2) 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 Herpes Simplex Virus (HSV-1/2) MC PCR Kit HSV/MC/205 PCR for 180 quantitative tests

EQA Panels

EQA results

; GP_MC_HSV_QCMD_01_22_EN
pdf, [222.48 kB]
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Technical specification

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

Documentation

Instruction for Use

; GP_MC_HSV_Instruction_for_Use_EN
pdf, [262.75 kB]

Declaration of Conformity

; GP_MC_HSV-1_2_Declaration_of_Conformity_EN
pdf, [618.35 kB]
Files are available only for registered users.

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