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PCRun® Technical Information

Discover the advantages that Biogal’s PCRun has over standard PCR tests. See all the information you need to operate PCRun in order to detect the presence of infectious diseases.

PCR testing allows for rapid and highly specific diagnosis of infectious diseases, including those caused by bacteria or viruses.

The high sensitivity of PCR permits earlier detection of acute infections  even before the onset of disease. Such early detection gives vets a significant lead time in treatment.

The PCRun methodology is easier to use and the test can be performed simply in a clinic or a lab.

PCRun also provides the same reliability  expected from PCR testing. The whole PCRun detection process is no longer than 75 minutes.

PCRun Molecular Detection Kit  makes Polymerase Chain Reaction testing:

  • Faster, more accessible & affordable PCR test
  • Flexible, meaning it can be used in small animal veterinary lab and/or clinic.
  • No need for expensive devices and multiple steps

Diagnosis in 3 steps:

  1. DNA Extraction – blood, bone marrow, urine feces, swab
  2. DNA Amplification
  3. Results Reading

Detection Limit, Inclusivity and Exclusivity of PCRun Reactions

PathogenAnalytical Detection Limit*,1Inclusivity**, 2Exclusivity**,2
Babesia gibsoni101B. gibsoniB. rossi, B. vogeli, B. canis, E.canis, A. platys
Babesia canis102B. canis, B. vogeliB. rossi, B. microti

B. gibsoni, E. canis, A. platys

Anaplasma platys102    (101 -83%)#A.       platys
Ehrlichia canis102     (101 – 84%)#E. canis, E. chaffeensis, E. phagocytophilum (weak)E. ewingii,  B. gibsoni,       A. platys, B. canis
Canine Parvovirus103Canine parvovirus,  Feline Panleukopenia virus
Mycoplasma haemofelis102M. haemofelis,

M. haemocanis

Bartonella sp.,

C.M. haemominutum,

C. M. turicensis

 Leptospirosis102     (101 – 83%)#Pathogenic leptospires (see attached file)Saprophytic leptospires
Leishmania infantumL. infantum, L. tropicaL. major, L. donavani
Feline Leukemia Virus102Feline Leukemia virus

Feline Leukemia provirus

Conserved endogenous FeLV-related sequences
Canine Parvovirus103Canine ParvovirusDistemper Virus, Adenovirus
Canine Distemper Virus102Canine Distemper VirusParvoVirus

#refers to the % of known positive samples at the specific concentration which returned a positive response in 60 min.

Study Design:

  1. DNA was extracted from whole blood collected from a canine blood donor. Lyophilized positive controls which consisted of PCR products were reconstituted in the DNA to concentrations ranging from 104 -101 copies of each target/5 μl DNA. The diluted DNA was used in the PCRun reactions.
  2. DNA was extracted from pre analyzed (Real Time PCR) blood samples or specific cultured pathogens and target sequences amplified with PCRun® DNA Detection Kits.
    * Analytical Detection Limit (Sensitivity) – the number of target copies per 5 μl of extracted canine total DNA.
    ** Inclusivity – capacity to detect only the target organism
    *** Exclusivity – capacity of not detecting non–targets.

Analytical Specificity – the ability of an assay to distinguish target from non-target and the capacity of an assay to detect or quantify only the nucleic acid target of interest. This is a combination of the analytical detection level, specificity and exclusivity.

PCRun Sensitivity and Specificity

ProductSensitivitySpecificityComparative MethodComments
PCRun®   Prep

n=120

96.7%97.8%PCRun®  Prep

vs

Qiagen DNA easy Kit

Sample Prep performance data determined using PCRun®  Ehrlichia Kit
ProductSensitivitySpecificityComparative Method
 

 Ehrlichia PCRun®

(n=175)

 

100%

 

99.3%

PCRun®  Reaction (Nucleotide detection device)

vs

TaqMan Real Time PCR

(Qiagen  Blood and Tissue Prep)

 

97%

 

100%

PCRun®  Reaction (PCRun®  Reader analysis)

vs

TaqMan Real Time PCR

(Qiagen Blood and Tissue Prep)

 Mycoplasma PCRun®

(n=43 bloods)

 

79%

 

100%

PCRun®  Reaction with  PCRun®  Prep

vs

Endpoint PCR

( Qiagen Blood and Tissue Prep for both)

 

95%

 

100%

PCRun®  Reaction

vs

Endpoint PCR

(Qiagen Blood and Tissue Prep for both)

Mycoplasma PCRun®

n=90 bloods

95%100%PCRun®  Reaction

vs

Endpoint PCR

(Qiagen Blood and Tissue Prep for both)

Anaplasma PCRun®

PCRun®

(n=28 bloods)

 

95%

 

100%

PCRun®  Reaction

vs

Real Time PCR

(Qiagen Blood and Tissue Prep for both)

 

Babesia gibsoni

PCRun®

(n=30 bloods)

 

92%

 

100%

PCRun®  Reaction (PCRun®  Reader analysis)

vs

TaqMan Real Time PCR

(Qiagen Blood and Tissue Prep for both)

Canine Parvovirus

(N=14 plasma samples)

100%100%PCRun®  Reaction (PCRun®  Reader analysis)

vs

TaqMan Real Time PCR

(Zymo  Quick-DNA™ Miniprep Kit for both)

Canine Distemper Virus

(N=35 nose swabs)

100%100%PCRun®  Reaction (PCRun®  Reader analysis)

vs

TaqMan Real Time PCR

(Zymo- ZN Viral RNA Kit for both)

To obtain full data of sensitivity/specificity on PCRun kits not mentioned in this table, contact Biogal at info@biogal.com