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PR2026-ST01
Bioteke
For RESEARCH USE ONLY. (PR2026-ST01)
INTENDED USE
This kit is used for qualitative diagnostic testing of 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 nucleic acid in vaginal swabs and urine from Sexually transmitted infection(STI) suspected patients.
KIT COMPONENTS
Components | 8 samples/kit | 24 samples/kit |
ST01 Lyophilized Reagent | 8*4 strip tubes | 24*4 strip tubes |
STI Lysis Buffer | 1 mL*1 tube | 5 mL*1 tube |
One Test Glass Beads | 8 tubes*1 bag | 8 tubes*3 bags |
STI Positive Control | 400 μL*1 tube | 400 μL*1 tube |
STI Negative Control | 400 μL*1 tube | 400 μL*1 tube |
Dissolving Solution | 1 mL*1 tube | 1 mL*2 tubes |
STORAGE & SHELF LIFE
-20℃±5℃ storage for 12 months.
Room temperature transportayion less than 1 month.
Repeated freezing and thawing should not exceed 7 times.
Valid for 12 months.
SPECIMEN
Vaginal swab, Urine.
EQUIPMENTS & MATERIALS REQUIRED
Disposable powder free gloves and other personal protective equipment.
Pipettes (adjustable) and Sterile pipette tips.
Vaginal swabs/urine sample collection device.
1.5 mL centrifuge tubes and racks.
Bench top centrifuge for centrifuge tubes and PCR tubes.
Vortex mixer.(Power≥40w)
Centrifuge tube holder for vortex mixer. (not necessary,can replace part of manual operation)
Metal bath/water bath.(1.5mL centrifuge tube,95℃)
Real-time PCR instrument with FAM/VIC/ROX/CY5 fluorescence channels.(Such as ABI7500, Bio-rad CFX96, QuantStudio, SLAN-96S, BTK-96)
PERFORMANCE SPECIFICATIONS
Detection limitation: 1000 Copies/mL.
Precision: The coefficient of variation (CV, %) of Ct value of within-batch/between-batch precision is ≤ 5%.
Accuracy: The conformity rate of negative/positive reference: 100%.
Specificity:The target organisms had been analyzed in silico for potential cross-reactivity with the primers or probe sequences.Homology with other species is all below 90%. Specificity analysis showed that there is no cross reaction between the pathogens detected by this kit.
CERTIFICATES
CE Mark.
ISO9001
ISO14001
ISO45001
IPMS
STDs RELATED RAPID TESTS
For RESEARCH USE ONLY. (PR2026-ST01)
INTENDED USE
This kit is used for qualitative diagnostic testing of 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 nucleic acid in vaginal swabs and urine from Sexually transmitted infection(STI) suspected patients.
KIT COMPONENTS
Components | 8 samples/kit | 24 samples/kit |
ST01 Lyophilized Reagent | 8*4 strip tubes | 24*4 strip tubes |
STI Lysis Buffer | 1 mL*1 tube | 5 mL*1 tube |
One Test Glass Beads | 8 tubes*1 bag | 8 tubes*3 bags |
STI Positive Control | 400 μL*1 tube | 400 μL*1 tube |
STI Negative Control | 400 μL*1 tube | 400 μL*1 tube |
Dissolving Solution | 1 mL*1 tube | 1 mL*2 tubes |
STORAGE & SHELF LIFE
-20℃±5℃ storage for 12 months.
Room temperature transportayion less than 1 month.
Repeated freezing and thawing should not exceed 7 times.
Valid for 12 months.
SPECIMEN
Vaginal swab, Urine.
EQUIPMENTS & MATERIALS REQUIRED
Disposable powder free gloves and other personal protective equipment.
Pipettes (adjustable) and Sterile pipette tips.
Vaginal swabs/urine sample collection device.
1.5 mL centrifuge tubes and racks.
Bench top centrifuge for centrifuge tubes and PCR tubes.
Vortex mixer.(Power≥40w)
Centrifuge tube holder for vortex mixer. (not necessary,can replace part of manual operation)
Metal bath/water bath.(1.5mL centrifuge tube,95℃)
Real-time PCR instrument with FAM/VIC/ROX/CY5 fluorescence channels.(Such as ABI7500, Bio-rad CFX96, QuantStudio, SLAN-96S, BTK-96)
PERFORMANCE SPECIFICATIONS
Detection limitation: 1000 Copies/mL.
Precision: The coefficient of variation (CV, %) of Ct value of within-batch/between-batch precision is ≤ 5%.
Accuracy: The conformity rate of negative/positive reference: 100%.
Specificity:The target organisms had been analyzed in silico for potential cross-reactivity with the primers or probe sequences.Homology with other species is all below 90%. Specificity analysis showed that there is no cross reaction between the pathogens detected by this kit.
CERTIFICATES
CE Mark.
ISO9001
ISO14001
ISO45001
IPMS
STDs RELATED RAPID TESTS
Telephone/Whatsapp: +86 18115363743
Email : zr@bioteke.cn