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GeneProof Team
RNA extraction, reverse transcription and PCR amplification
Product name | Catalog no. | Technology | Packaging |
GeneProof HIV type 1 (HIV-1) PCR Kit | HIV/ISEX/025 | real-time PCR | 25 reactions |
GeneProof HIV type 1 (HIV-1) PCR Kit | HIV/ISEX/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device |
Intended User | For professional use in laboratories with trained staff |
Technology | real-time PCR |
Type of Analysis | qualitative and quantitative |
Target Sequence |
LTR sequence and GaG gene |
Analytical Specificity |
HIV genotypes A - D, AE, F, AG-GH, Group N, Group O, BF, H, K, CRF03_AB, 100% |
Analytical Sensitivity (LOD) | reaches up to 273.971 IU/ml i.e. 153.424 cp/ml with the probability of 95 % (on HIV-1 NIBSC 16/194 using manual extraction GeneProof PathogenFree RNA Isolation Kit) reaches up to 548.121 IU/ml i.e. 306.948 cp/ml with the probability of 95 % (on HIV-1 NIBSC 16/194 using automatic extractor croBEE NA16 Nucleic Acid Extraction System) reaches up to 98.59 IU/ml i.e. 55.21 cp/ml with the probability of 95 % (on Acrometrix HIV-1 Panel IU/ml using manual extraction SpinStar Viral Nucleic Acid Kit 1.0 with SpinStar Pretreatment Solution) |
Diagnostic Specificity | 100 % (CI95 % : 99.10 % - 100 %) |
Diagnostic Sensitivity |
93.66 % (CI95 % : 87.96 % - 96.88 %) |
Linear Range |
109– 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree RNA Isolation Kit) |
Dynamic Range |
109 – 273.971 IU/ml (using manual extraction GeneProof PathogenFree RNA Isolation Kit) |
Reporting Units |
IU/μl |
Conversion Factor |
1 IU = 0.56 cp |
Metrological Traceability | HIV NIBSC 16/194 |
Extraction/Inhibition Control | PCR inhibition and RNA extraction efficiency control (ISEX version) |
Validated Specimen | plasma |
Storage | -20 ± 5 °C |
Validated Extraction Method | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree RNA Isolation Kit |
Instruments |
croBEE Real-Time PCR System |
Required Detection Channels | FAM, HEX |
External Quality Assessment | Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels - results at www.geneproof.com |
Regulatory Status | CE1023 IVD |
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