i.Mune® CD4 [RUO]

i.Mune CD4 [RUO] is a quantitative in vitro test to determine the percentages and absolute counts of human CD4+ T lymphocytes in liquid venous whole blood and capillary whole blood specimens dried on filter paper (Dried Blood Spot; DBS).

Please note - i.Mune CD4 is for research use only. Not for diagnostic purposes.

i.Mune CD4 [RUO] enables the epigenetic quantification of:

• Helper T lymphocytes (CD3+CD4+)

Throughput:

• Process up to 68 samples, plus Controls, Standard, in one PCR-run (96-well)

• Capillary whole blood dried on filter paper (DBS)
• • Samples can be stored at room temperature (15°C to 30°C) or frozen (-30°C to -15°C) for up to 12 weeks
  • DBS sample stability has been demonstrated at 55°C and 65-78% humidity for up to 7 days 

OR

• 40 µl of liquid venous whole blood collected in K₂EDTA blood collection tube
• • Samples can be stored at room temperature (15°C to 30°C) for up to 24 h or frozen (-30°C to -15°C) for up to 12 weeks

Quantification of  CD4+ lymphocytes can be useful for*:

• Monitoring of HIV-positive patients ^{1),2), 3)}

Please note - i.Mune CD4 is for research use only. Not for diagnostic purposes.

97 blood samples from HIV positive subjects (liquid and dried) were analyzed using flow cytometry (liquid blood) and epigenetic qPCR (liquid and dried), respectively. The data show excellent correlation between both testing methods and between liquid and dried blood ¹⁾.

Based on the existing i.Mune TBNK product, we developed a new, low-cost, multiplex PCR assay called i.Mune CD4 that can be shipped under ambient conditions. The assay was evaluated in a proof-of-concept study involving 200 patient samples exhibiting various haematological diseases and conditions (e.g. HIV, PID, and stem cell transplantation). CD4 cell counts were measured using the BD FACSLyric™ Flow Cytometry System and ranged from a few CD4 cells to 1,500 CD4 cells/µl. In addition to frozen EDTA blood, venous DBS was generated to enable comparison of liquid blood and DBS. The test was performed on three different PCR cyclers: the Roche LC480II, the Roche LC PRO and the Thermo Fisher QuantStudio 6. In all cases, quantitative CD4 cell determination correlated excellently with minimal bias in the results obtained by the PCR method and flow cytometry.³⁾

97 blood samples from HIV positive subjects (liquid and dried) were analyzed using flow cytometry (liquid blood) and epigenetic qPCR (liquid and dried), respectively. The data show excellent correlation between both testing methods and between liquid and dried blood ¹⁾.

Based on the existing i.Mune TBNK product, we developed a new, low-cost, multiplex PCR assay called i.Mune CD4 that can be shipped under ambient conditions. The assay was evaluated in a proof-of-concept study involving 200 patient samples exhibiting various haematological diseases and conditions (e.g. HIV, PID, and stem cell transplantation). CD4 cell counts were measured using the BD FACSLyric™ Flow Cytometry System and ranged from a few CD4 cells to 1,500 CD4 cells/µl. In addition to frozen EDTA blood, venous DBS was generated to enable comparison of liquid blood and DBS. The test was performed on three different PCR cyclers: the Roche LC480II, the Roche LC PRO and the Thermo Fisher QuantStudio 6. In all cases, quantitative CD4 cell determination correlated excellently with minimal bias in the results obtained by the PCR method and flow cytometry.³⁾

1. Baron U. et al. Epigenetic immune cell counting in human blood samples for immunodiagnostics. Sci Transl Med. 2018 Aug 1; 10 (452)
2. Ford N, et al. The evolving role of CD4 cell counts in HIV care. Curr Opin HIV AIDS. 2017 Mar;12(2):123-128
3. Schulze J, et al. A novel qPCR method to count CD4+ T helper cells using dried blood. Poster at IAS 2024.
   
   

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