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PR2026-HP04
Bioteke
A. Intended Use
This kit is used for in vitro qualitative detection of high-risk and low-risk human papillomavirus(HPV).
The high-risk HPV includes type 16,18,26,31,33,35,39,45,51,52,53,56,58,59,66,68,73,82;
The low-risk HPV includes type 6,11,40,42,43,44/55,54,57/71,61,70,72,81,84.
B. Principle
This reagent is a multiplex fluorescent probe-based Taqman® qPCR assay system.
Specific primers and probes are designed for detection of different types of human papillomavirus (HPV).
Internal control (IC) is used as a monitoring method to avoid false negative test results.
UDG enzyme/dUTP system is added to degrade the amplification product to avoid false positive results.
This kit is a fully premixed lyophilized system. Taq enzyme, UDG enzyme, reaction buffer, specific primers and probes have been pre-placed in the reagents.
C. Components
Conponents | 8 samples/kit | 24 samples/kit | Ingredient |
HP04 Lyophilized Reagent | 8×8 strip tubes | 24×8 strip tubes | Specific primer&probes for the detection of target pathogens, dNTP/dUTP Mix, Mg2+, Tac polymerase and UDG enzyme |
HPV Lysis Buffer | 1 mL×1 tube | 2.5 mL×1 tube | Surface active agent, balanced salt solution |
HPV Positive Control | 400 mL×1 tube | 400 mL×1 tube | Plasmid containing every target gene sequence |
HPV Negative Control | 400 mL×1 tube | 400 mL×1 tube | Plasmid containing internal control sequence |
Dissolving Solution | 1 mL×1 tube | 1 mL×3 tubes | Stabilizer |
D. Storage and Shelf Life
Transportation at room temperature below 37℃(<1 month).
Stored at -20℃±5℃ for 1 year.
Repeated freezing and thawing should not exceed 7 times.
E. Overview of the Testing Process
F. PCR Amplification
Put the reaction tubes into PCR instrument and set the names of each reaction well in the corresponding order.
Select FAM,VIC/HEX,ROX and CY5 four fluorescence channels for detection.The corresponding targets of each fluorescence channel are shown in the table below:
Location | FAM | VIC/HEX | ROX | CY5 |
Well 1 | HPV type 16 | HPV type 18 | HPV type 26 | Internal Control (IC) |
Well 2 | HPV type 31 | HPV type 33 | HPV type 35 | HPV type 39 |
Well 3 | HPV type 45 | HPV type 51 | HPV type 52 | HPV type 53 |
Well 4 | HPV type 56 | HPV type 58 | HPV type 59 | HPV type 68 |
Well 5 | HPV type 66 | HPV type 73 | HPV type 82 | HPV type 81 |
Well 6 | HPV type 6 | HPV type 11 | HPV type 40 | HPV type 42 |
Well 7 | HPV type 43 | HPV type 44/55 | HPV type 54 | HPV type 61 |
Well 8 | HPV type 57/71 | HPV type 70 | HPV type 72 | HPV type 84 |
G. Results Analysis and Interpretation
Please refer to the user manual.
H. Performance Specification
1.Detection limitation: 1000 Copies/mL
2.Precision: The coefficient of variation (CV,%) of Ct value of within-batch/between-batch precision is≤5%.
3.Accuracy: The conformity rate of negative/positive reference:100%.
4.Specificity:The farget organisms had been analyzed in silico for potential cross-reactivity with the primers or probe sequences.
Homology with other species is all below 80%.
Specificity analysis showed that there is no cross reaction with trichomonas vaginalis, neisseria gonorrhoeae, chlamydia trachomatis, gardnerella vaginalis, haemophilus ducreyi, candida albicans, streptococcus agalactiae, ureaplasma urealyticum, ureaplasma parvum, mycoplasma hominis, mycoplasma genitalium, treponema pallidum, herpes simplex virus type 1&2.
A. Intended Use
This kit is used for in vitro qualitative detection of high-risk and low-risk human papillomavirus(HPV).
The high-risk HPV includes type 16,18,26,31,33,35,39,45,51,52,53,56,58,59,66,68,73,82;
The low-risk HPV includes type 6,11,40,42,43,44/55,54,57/71,61,70,72,81,84.
B. Principle
This reagent is a multiplex fluorescent probe-based Taqman® qPCR assay system.
Specific primers and probes are designed for detection of different types of human papillomavirus (HPV).
Internal control (IC) is used as a monitoring method to avoid false negative test results.
UDG enzyme/dUTP system is added to degrade the amplification product to avoid false positive results.
This kit is a fully premixed lyophilized system. Taq enzyme, UDG enzyme, reaction buffer, specific primers and probes have been pre-placed in the reagents.
C. Components
Conponents | 8 samples/kit | 24 samples/kit | Ingredient |
HP04 Lyophilized Reagent | 8×8 strip tubes | 24×8 strip tubes | Specific primer&probes for the detection of target pathogens, dNTP/dUTP Mix, Mg2+, Tac polymerase and UDG enzyme |
HPV Lysis Buffer | 1 mL×1 tube | 2.5 mL×1 tube | Surface active agent, balanced salt solution |
HPV Positive Control | 400 mL×1 tube | 400 mL×1 tube | Plasmid containing every target gene sequence |
HPV Negative Control | 400 mL×1 tube | 400 mL×1 tube | Plasmid containing internal control sequence |
Dissolving Solution | 1 mL×1 tube | 1 mL×3 tubes | Stabilizer |
D. Storage and Shelf Life
Transportation at room temperature below 37℃(<1 month).
Stored at -20℃±5℃ for 1 year.
Repeated freezing and thawing should not exceed 7 times.
E. Overview of the Testing Process
F. PCR Amplification
Put the reaction tubes into PCR instrument and set the names of each reaction well in the corresponding order.
Select FAM,VIC/HEX,ROX and CY5 four fluorescence channels for detection.The corresponding targets of each fluorescence channel are shown in the table below:
Location | FAM | VIC/HEX | ROX | CY5 |
Well 1 | HPV type 16 | HPV type 18 | HPV type 26 | Internal Control (IC) |
Well 2 | HPV type 31 | HPV type 33 | HPV type 35 | HPV type 39 |
Well 3 | HPV type 45 | HPV type 51 | HPV type 52 | HPV type 53 |
Well 4 | HPV type 56 | HPV type 58 | HPV type 59 | HPV type 68 |
Well 5 | HPV type 66 | HPV type 73 | HPV type 82 | HPV type 81 |
Well 6 | HPV type 6 | HPV type 11 | HPV type 40 | HPV type 42 |
Well 7 | HPV type 43 | HPV type 44/55 | HPV type 54 | HPV type 61 |
Well 8 | HPV type 57/71 | HPV type 70 | HPV type 72 | HPV type 84 |
G. Results Analysis and Interpretation
Please refer to the user manual.
H. Performance Specification
1.Detection limitation: 1000 Copies/mL
2.Precision: The coefficient of variation (CV,%) of Ct value of within-batch/between-batch precision is≤5%.
3.Accuracy: The conformity rate of negative/positive reference:100%.
4.Specificity:The farget organisms had been analyzed in silico for potential cross-reactivity with the primers or probe sequences.
Homology with other species is all below 80%.
Specificity analysis showed that there is no cross reaction with trichomonas vaginalis, neisseria gonorrhoeae, chlamydia trachomatis, gardnerella vaginalis, haemophilus ducreyi, candida albicans, streptococcus agalactiae, ureaplasma urealyticum, ureaplasma parvum, mycoplasma hominis, mycoplasma genitalium, treponema pallidum, herpes simplex virus type 1&2.
Telephone/Whatsapp: +86 18115363743
Email : zr@bioteke.cn