AltoStar® CMV PCR Kit 1.5
AS0021543
In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® CMV PCR Kit 1.5 has received a new product number and Global Trade Item Number (GTIN). The new product number reflects the desired change in regulatory status. All other product characteristics as well as the product performance remain unchanged. The kit is chemically identical to its already existing counterpart and contains the same kit components.
AltoStar® CMV PCR Kit 1.5 
AltoStar® CMV PCR Kit 1.5
Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.
Key features
- Detection and quantification of cytomegalovirus (CMV) specific DNA
- CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in IU/ml
Limit of detection (LoD)
| LoD plasma | 215 IU/ml |
| LoD whole blood |
305 IU/ml |
| LoD urine |
711 IU/ml |
Sample types
The following sample types are validated for use with the AltoStar® CMV PCR Kit 1.5:
Human EDTA plasma
Human citrate plasma
Human EDTA whole blood
Human citrate whole blood
Human urine
Other workflows
The AltoStar® CMV PCR Kit 1.5 can be used with compatible workflows (manual or automated). Real-time PCR instruments that have been validated for use with the AltoStar® CMV PCR Kit 1.5 are:
CFX96™ Deep Well Dx System (Bio-Rad)
CFX96™ Dx System (Bio-Rad)
ABI Prism® 7500 SDS (Applied Biosystems)
LightCycler® 480 Instrument II (Roche)
QuantStudio™ 5 Real-Time PCR System (Applied Biosystems)
Rotor-Gene® Q5/6 plex Platform (QIAGEN)
The AltoStar® CMV PCR Kit 1.5 can be used with nucleic acid extraction systems other than the AltoStar® AM16. Alternative procedures used for nucleic acid extraction have to be validated by the user.
Intended use
The AltoStar® CMV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of cytomegalovirus (CMV) specific DNA in human plasma, whole blood and urine. It is intended to be used as an aid for diagnosis of CMV infection and for monitoring of the CMV load in individuals with CMV infection.
AltoStar® CMV PCR Kit 1.5
| Order No. | AS0021543 |
| Rxns | 96 |
| Transportation | Dry ice |
| Regulatory status | CE-IVD |
AltoStar® CMV PCR Kit 1.5
| Veröffentlichungsdatum: | 08/2021 |
| Regulatorischer Status: | CE-IVD |
| Release date: | 08/2021 |
| Regulatory status: | CE-IVD |
| Date de sortie: | 08/2021 |
| Statut réglementaire: | CE-IVD |
| Fecha de lanzamiento: | 08/2021 |
| Situación reglamentaria: | CE-IVD |
| Data de lançamento: | 08/2021 |
| Estatuto regulamentar: | CE-IVD |
| Data di rilascio: | 08/2021 |
| Stato normativo: | CE-IVD |
| Data wydania: | 08/2021 |
| Status prawny: | CE-IVD |
| Ngày ban hành: | 08/2021 |
| Tình trạng pháp lý: | CE-IVD |
AltoStar® CMV RT-PCR Kit 1.5 - Certificates
| Veröffentlichkeitsdatum: | 13.05.2022 |
AltoStar® CMV PCR Kit 1.5 - Certificate_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (EN)
pdf| Release date: | 13.05.2022 |
| Date de sortie: | 13.05.2022 |
AltoStar® CMV PCR Kit 1.5 - Certificado_Annex IV 98-79 CE_CMV_HCV-HBV-HIV (ES)
pdf| Fecha de lanzamiento: | 13.05.2022 |
AltoStar® CMV PCR Kit 1.5 - Certificado_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (PT)
pdf| Data de lançamento: | 13.05.2022 |
AltoStar® CMV PCR Kit 1.5 -Certificate_Sistema di qualita_Annex IV 98-79 CE CMV-HCV-HBV-HIV (IT)
pdf| Data di rilascio: | 13.05.2022 |
AltoStar® CMV PCR Kit 1.5
Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)
pdf| Veröffentlichungsdatum/Release date/Date de sortie: | 18.05.2022 |
| Regulatorischer Status/Regulatory status/Statut réglementaire: | CE-IVD |
Declaración de conformidad/Dichiarazione di conformità/Declaração de conformidade (ES, IT, PT)
pdf| Fecha de lanzamiento/Data di rilascio/Data de lançamento: | 18.05.2022 |
| Situación reglamentaria/Stato normativo/Estatuto regulamentar: | CE-IVD |