Cytomegalovirus PCR kit

REF 88-01 Form S
REF 88-02 Form T

CE ₀₄₈₃ IVD

Product description

The Cytomegalovirus PCR kit is Real Time PCR test for fast and qualitative detection of Cytomegalovirus (CMV) DNA in samples extracted from genitourinary, rectal, and oral swabs, urine, saliva, whole blood, blood plasma for diagnosis of CMV presence.

Technical specification

Assay Principle	Real Time PCR test for detection of Cytomegalovirus DNA
Test results	qualitative
Sample material	genitourinary, rectal, and oral swabs; urine; saliva; whole blood, blood plasma samples
Analytical Sensitivity	1000 copies of CMV genomic DNA per 1 mL (i.e. 10 copies of genomic DNA per reaction)
Controls included in the kit	• positive control • negative control • internal control
Steps	• DNA Extraction • PCR amplification • Analysis of data
Validated extraction methods	Multi DNA Extraction kit (Astra Biotech GmbH) Rapid DNA Extraction kit (Astra Biotech GmbH)
Storage	-18…-30°C, transportation for 7 days at room temperature possible
Approval	for in-vitro Diagnostics, CE 0483

Format	Format S	Format T
Kit Size	• REF 88-01, 112 tests • REF 88-01-56, 56 tests	• REF 88-02, 112 Tests • REF 88-02-56, 56 Tests
Format Description	liquid reaction mix aliquoted into 0.2 mL low profile 8 tube strips; DNA polymerase in a separate tube	liquid reaction mix aliquoted into 0.2 mL regular profile reaction tubes; DNA polymerase in a separate tube
Kit content	PCR-Mix CMV, Form S; Taq DNA-polymerase, positive control, internal control, negative control	PCR-Mix CMV, Form Т; Taq DNA-polymerase, positive control, internal control, negative control
Validated Thermocycler	Bio-Rad CFX96 Roche Light Cycler 96 DNA-Technology DTprime, DTlite, SaCycler	Qiagen Rotor-Gene Q, Rotor-Gene 3000/6000