HCY™ Borrelia Burgdorferi PCR Detection Kit is a fluorescent quantitative assay for the detection of narrowly defined Borrelia burgdorferi spirochetes (B. burgdorferisensu srricto) in samples such as urine, blood and tissue. The specific primers and Taqman probe are designed with the conserved genes of B. burgdorferiensu srricto, and amplified by fluorescence quantitative PCR instrument. Meanwhile, this kit uses GAPDH gene as the internal reference gene, which meets the requirements of indoor quality control in the whole process from sampling, sample purification to on-line testing.
Designed based on the gene sequences of pathogens prevalent in various regions of the world, fully guaranteeing the accuracy and validity of the test;
The primers are designed with special bases to reduce the risk of missed detection due to gene mutation;
Adopting pre-filled freeze-dried microsphere technology for transportation and storage at room temperature;
Easy to use, no need to prepare reagents in advance;
The minimum detection limit is 50 copies/Test;
Clinical sensitivity 100%, specificity 100%;
Add internal standard to prevent false negative results and facilitate indoor quality control.
Quality by Design
The sequences of B. garinii (NC_017804.1), B. burgdorferi sensu stricto (CP002950.1), B. bissettii (CP002761.1), B. afzelii (NZ_JALGSO010000002.1), B.valaisian (NC_012177.1) together 49 sequences were aligned for homology comparison and constructed for evolutionary tree analysis.
HCY™ Borrelia Burgdorferi PCR Detection Kit is designed and developed based on the gene sequences of endemic pathogens in different regions of the world, as mentioned above, which fully ensures the accuracy and validity of the detection. At the same time, special bases are introduced in the primer sequence synthesis process to reduce the risk of missed detection due to gene mutation.
LoD and PCR Efficiency
Using real clinical samples, the assay was performed after serial gradient dilution, and the results showed good linear characteristics, and the calculated copy number was as low as 50 copies/Test. Calculation of the experimental data set yielded R2=0.9939 and the amplification efficiency E=105.39%.
Sensitivity and Specificity
The HCY™ Feline herpesvirus Real-time PCR Detection Kit was compared to similar commercially available products and tested 262 real clinical samples, of which the sensitivity was 100% and the specificity 100%.
Reference Product
Total
Negative
Positive
HCY™ PCR Test Kit
Positive
0
8
8
Negative
254
0
254
Total
254
8
262
Estimated Value
95% Confidence Interval
Sensitivity
100%
59.77%~100%
Specificity
100%
98.14%~100%
Cross-reactivity
The HCY™ Borrelia Burgdorferi Real-time PCR Detection Kit has been validated for the detection of Feline herpesvirus, Bartonella, Toxoplasmosis, Leptospira, Bordetella bronchiseptica Feline Calicivirus, Feline coronavirus, Feline Parvovirus, Chlamydia felis, Mycoplasma haemofelis, Candidatus Mycoplasma haemominutum and Candidatus Mycoplasma haemominutum. Candidatus Mycoplasma turicensis, Canine parainfluenza Virus, Canine Coronavirus, Canine Herpesvirus, Canine Distempervirus, and Canine Parvovirus. None of them cross-reacted.
“HCY, Health care for you” is our forever mission. We dedicate to offering safe & reliable products and medical services with our global creditable partners. HCY has already supplied to WHO, MAYO clinic, MGI, DDC, Yale University, Qorvo, Quanterix, Thomas Scientific, SD biosensor, Cardinal Health, Cleveland Clinic, Mars Petcare & LumiraDx, etc. in the past years.