This molecular diagnostic PCR kit is CE approved and complies with the Directive 98/79/EC for IVD, in vitro PCR Diagnostics. The PCR kit is ISO 9001:2008 and ISO 13485:2012, CE marked with the in vitro diagnostic medical divices requirements Annex 2 of list B of the laboratory Directive 98/79/EC and can be used for diagnosis of viruses. The kit inculde all reagents for PCR or RT-PCR of viral DNA or RNA.
The detections of the targets with this kit is a type of test that can be performed on any target containing biological samples after clean up of interfering agents. The assay must be performed following the protocol.
This HPV 6/11 PCR kit with Electrophoretic Detection of HPV 31 and 33 is used as PCR kit for molecular diagnostics with elecrtophoresis, qPCR or real-time PCR of 55 Tests per screening.
TAQ or Pfu or Pfx or other enzymes are used for polycmerase chain reaction and have different specificity. The mores specific the lower the yield.
Thermocyclers can be callibrated for identical ramping curves to obtain a more accurate PCR.
PCR, polymerase chain reaction