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

https://msf.oodin.sh/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)

​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 lateral flow assay (LFA) is a disposable, that provides a visually read semi-quantitative result - above or below a threshold of 200 cells/µL - within 40 minutes.

This‌ test is used for expanded screening of patients with advanced HIV disease (AHD).

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: 30 µL capillary or venous (EDTA); venous preferred
  • Time to result: 40-45 minutes
  • Format: Lateral flow cassette - visual reading
  • 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)
  • Performance review of published studies, see MSF internal communication, November 2025

Packaging & Labelling

25 tests/pack

Instructions for use

Read the manufacturer instruction for use.

The test result is interpreted by comparing the intensity of the Test (T) line with the Reference (200) line. If the test line has equal or weaker intensity than the reference line (200), the test result is 'below reference' (≤200 CD4+ T cells/μL). If the test (T) line has stronger intensity than the Reference (200) line, the test result is 'Above Reference' (> 200 CD4+ T cells/µl)

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Precautions for Use

Important note about intended use:

  • VISITECT CD4 Advanced Disease is for professional use only.
  • VISITECT CD4 Advanced Disease is not intended for individuals <5 years of age.
  • VISITECT CD4 Advanced Disease is not intended for use in the determination of HIV status.
  • VISITECT CD4 Advanced Disease is not intended for self-testing.

Storage

  • Store between 2-30°C. Do not freeze.
  • Shelflife: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life

MSF requirements

MSF recommends the expanded use of the VISITECT CD4 LFA for screening advanced HIV disease (AHD) in all settings where instrument-based CD4 testing is unavailable or limited.

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