*Fluorescence PCR method.
*Screening and detection both of 19 common pathogens DNA and 12 common drug(antibiotics) resistance genes.
*Lyophilized reagents.
Validity: 12 Months
Model: PR2028-WP01
Specification: 8 Tests/Kit; 24 Tests/Kit
Intended Use
The kit is qualitative in vitro detection of 19 common pathogens DNA and 12 common drug(antibiotics) resistance(DR) genes from wound swab.
The pathogens and drug resistance genes detected are shown in the following [table 1].
[table 1]
| Pathogen & DR gene type | Species |
Bacteria | Escherichia coli |
| Klebsiella aerogenes | |
| Klebsiella oxytoca | |
| Klebsiella pneumoniae | |
| Citrobacter spp.1 | |
| Enterobacter cloacae | |
| Acinetobacter baumannii | |
| Proteus mirabilis | |
| Pseudomonas aeruginosa | |
| Serratia marcescens | |
| Staphylococcus aureus | |
| Staphylococcus saprophyticus | |
| Streptococcus agalactiae | |
| Enterococcus faecalis | |
| Enterococcus faecium | |
| Morganella morganii | |
| Bacteroides fragilis | |
| Staphylococcus epidermidis | |
| Fungi | Candida albicans |
Drug resistance gene | blaKPC |
| blaNDM | |
| blaVIM | |
| blaIMP | |
| blaOXA-48 | |
| mecA | |
| vanA | |
| vanB | |
| CTX-M2 | |
| suL1 | |
| suL2 | |
| suL3 |
1. Include：Citrobacter freundii, Citrobacter werkmanii, Citrobacter portucalensis, Citrobacter youngae, Citrobacter cronae, Citrobacter braakii, Citrobacter arsenatis, Citrobacter amalonaticus, Citrobacter koseri.
2. Include：CTX-M 1 group, CTX-M 2 group, CTX-M 9 group.
Principle
The kit is designed with specific primers and probes for different common pathogens and drug resistance genes. Polymerase chain reaction (qPCR) and multiple fluorescent probe technique are used to amplify and detect specific nucleic acid sequences of pathogens and drug resistance genes listed in Table 1.
By adding edible yeast as internal control (IC), the extraction and detection process of pathogen nucleic acid from wound swab is monitored to effectively avoid false negative results. In order to avoid aerosol contamination of the amplified products, the UDG enzyme /dUTP system was added to the amplification system to effectively degrade the amplified products and avoid false positive results.
This kit is a fully premix freeze-dried system. Taq enzyme, UDG enzyme, reaction buffer, specific primers and probes required for amplification are all lyophilized in PCR tubes. A total of 1-8 Wells are lyophilized powders for different target genes. Detection can be performed directly after adding dissolving solution and extracted nucleic acid.
Operation Process
Advantages
1. Multiple quantitative analysis
19 common pathogen nucleic acids and 12 common antibiotics resistance genes
2. Rapid response
With a fast PCR instrument, the test can be completed in 60 minutes
3. Application scenarios
Urology routine testing/third-party testing laboratory/inspection department
Postoperative monitoring/disease control/scientific research units/doctors cooperate to publish articles
4. Product advantages
Freeze-dried system
Reduce transportation risks and increase stability
No extraction equipment required
Storage Conditions and Shelf Life
Store at -20℃±5℃
Transport at room temperature(≤37℃) for no more than 1 month.
Valid for 12 months
Components
Wound lyophilized reagent 8*8 strip tubes/24*8 strip tubes.
Internal Control Dry powder *1 tube.
Internal Control solution 1mL*1 tube.
Wound Positive control 300uL*1 tube.
Wound Negative control 300uL*1 tube.
Dissolving solution 1mL*1 tube/1mL*3 tubes.
Specimens Requirements
1). Wound swab, collected samples from margin to margin in a 10-point zigzag fashion.
2). The samples should be used for detection within the same day or stored at 2-8℃ less than 7 days. Stored at ＜20℃ for 6 months, avoiding repeated freeze-thaw cycles.
Performance
1). Detection limitation: 200 CFU/mL.
2). Precision: (CV, %) of Ct ≤5%.
3). Accuracy: The conformity rate of negative/positive reference 100%.
4). Specificity: Please refer to the User Manual.
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