PS103107A SA ZIKV RT-PCR Test说明书英文版.pdf

Sentosa® SA ZIKV RT-PCR Test (4x24) User manual Version 1.0 Vela Operations Singapore Pte Ltd, 50 Science Park Road, #05-07 The Kendall, Singapore 117406 300614 4x24 tests 4x24 European Conformity In vitro diagnostic medical device MAT PS103107A For Research Use Only Contents Intended use 1 Product use limitations 1 Safety information 2 Quality control 2 Important notes 3 General precautions 3 Laboratory procedures 3 Storage of nucleic acids 3 Items to be supplied by user 4 Introduction 6 Principle 6 Pathogen information 7 Workflow 8 Protocol: Automated nucleic acid extraction, PCR set-up and detection on the Sentosa® SX101 and the ABI 7500 Fast Dx Real-Time PCR instruments 10 1. Sample preparation 12 2. Automated nucleic acid extraction and PCR set-up on the Sentosa® SX101 instrument 13 3. PCR on the ABI 7500 Fast Dx Real-Time PCR Instrument or Sentosa® SA201 25 4. Data analysis and export on the ABI 7500 Fast Dx Real-Time PCR Instrument or Sentosa® SA201. 28 Results 30 Instrument maintenance 32 Performance Characteristics 33 Clinical performance 33 Analytical sensitivity 33 Analytical reactivity and specificity 34 Reproducibility 35 Interfering substances 35 Troubleshooting guide 36 References 39 Appendix A: Sentosa® SX101 layout for 24-1 VirLys3 v2-1 protocol (for 24 tests) 40 Symbols 41 Contacts 43 Sentosa® SA ZIKV RT-PCR Test (4x24) User Manual For in vitro diagnostic use Kit contents Kit name Quantity Volume