AltoStar® BKV PCR Kit 1.5

Order No AS0031543
Rxns 96
Transportation Dry ice
Regulatory status CE-IVD
Mã: AS0031543 Danh mục: Từ khóa:

THÔNG TIN MÔ TẢ

In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® BKV 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.

Products not FDA cleared or approved. Kits not available in all countries.

Intended use

The AltoStar® BKV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of BK virus (BKV) specific DNA in human plasma, whole blood and urine. It is intended to be used as an aid for diagnosis of BKV infection and for monitoring of the BKV load in individuals with BKV infection.

Specifications

Key features

  • Detection and quantification of BK virus (BKV) specific DNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD plasma 66 IU/ml
LoD whole blood 105 IU/ml
LoD urine 21 IU/ml

Sample types

The following sample types are validated for use with the AltoStar® BKV PCR Kit 1.5:

  • Human EDTA plasma
  • Human citrate plasma
  • Human EDTA whole blood
  • Human citrate whole blood
  • Human urine

Other workflows

The AltoStar® BKV 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® BKV PCR Kit 1.5 are:

  1. CFX96™ Deep Well Dx System (Bio-Rad)
  2. CFX96 Dx System (Bio-Rad)
  3. ABI Prism® 7500 SDS (Applied Biosystems)
  4. LightCycler® 480 Instrument II (Roche)
  5. QuantStudio™ 5 Real-Time PCR System (Applied Biosystems)
  6. Rotor-Gene® Q5/6 plex Platform (QIAGEN)

The AltoStar® BKV 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.

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