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CD4 TEST, 200 cells/µl, wb, 1 test (Visitect AB376)

https://unicat.msf.org/cat/product/94378
NST SSDTCD4T25T2

Valid Article

Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
P
The order of this product needs to be justified and is only acceptable under certain conditions.
CT30
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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CD4 TEST, 200 cells/µl, wb, 1 test (Visitect AB376)

This item is replacing SSDTCD4T25T, reason: new manufacturer and new reference SSDTCD4T25T2 is not yet validated as MSF standard.

Please contact the laboratory advisor in your OC for advise regarding the most adapted solution for CD4 count.

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 25.

Definition

The VISITECT CD4 Advanced Disease Rapid Test is a manually operated semi-quantitative assay for the estimation of CD4 protein on the surface of CD4+ T cells in human whole blood (capillary or EDTA venous) to indicate whether the level is above or below 200 cells/μL within pre-diagnosed HIV patients.

This test is a tool in the management of patients with advanced HIV disease (patients with CD4 count below 200 cells/µl).

Specifications

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Components

  • 25 foil pouch containing the test device and the desiccant
  • 1x 7mL bottle buffer
  • 25 Sample devices
  • 25 Retractable sterile lancets
  • 25 Alcohol swabs
  • 1 Job aid for whole blood specimens
  • 1 Job aid for whole blood specimens
  • 1 Instructions for use

Technical specifications

  • Specimen: capillary or venous EDTA blood
  • Time to result: 40-45 minutes
  • Visual read
  • Performance according to the WHO Prequalification report (July 2023):
    • Venous whole blood:
      • Sensitivity for detection of specimens with <=200 CD4+T cells/µL: 96,0% (95%CI: 90,1-98,9%)
      • Specificity (>200CD4+T cells/µl) 96,6% (95%CI: 92,3-98,3)
    • Capillary whole blood:
      • Sensitivity for detection of specimens with <=200 CD4+T cells/µL: 95,0% (CI 95%: 88,7-98,4)
      • Specifity (>200CD4+T cells/µl) : 97,0% (95% CI: 93,6-98,9)

Packaging & Labelling

25 tests/pack

Instructions for use

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Storage

  • Store between 2-30°C. Do not freeze.
  • Shelflife: 12 months (extension to 18 months is under WHO PQ evaluation)

MSF requirements

Follow-up of HIV patients in specific settings.

All orders of NST articles must be validated by your OC medical director.

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