HIV Diagnostic

to initiate maternal treatment and stop newborn transmission

Diagnostic
Diagnostic
  • PREVENTION
  • DIAGNOSTIC
  • TREATMENT
  • OVERVIEW
  • TECHNOLOGY Characteristics
  • HIV Diagnostic
    Representative Product

    Condition
    Human Immunodeficiency Virus (HIV) is a retrovirus that causes Acquired Immunodeficiency Syndrome (AIDS). Untreated, AIDS causes the immune system to fail, making patients vulnerable to life threatening opportunistic diseases. HIV can diminish the health of a mother and baby. In the absence of intervention, about one quarter of neonates will acquire the virus from their mothers resulting in 400,000 new cases per year. In high-resource settings, the mother to child transmission rate is less than 1%.

     

    Mechanism of Action
    HIV tests detect antibodies or antigens of HIV in saliva, whole blood, or serum. Antibody tests are simpler and less expensive, but cannot detect the virus in the 3-12 week window between HIV infection and seroconversion. Among point of care antibody tests used in clinical settings, serum tests have highest sensitivity (99-100%) followed by whole blood tests (94-99%), followed by oral tests (86.5%). Unlike antibody tests, nucleic acid-based tests (NATs) directly amplify and detect the genetic material of the HIV virus, and can therefore detect infection around 12 days after exposure. NAT requires relatively complex machinery and skill, most suitable for batch screening of multiple samples in a centralized laboratory setting.

     

    Current Use in High-Resource Settings
    Most HIV screening in high-resource settings takes place in centralized laboratories. In the US, the algorithm includes both an ELISA and western blot test for serum antibodies. Results are typically available several days after a blood sample is drawn.  Since 2001, 100% of US donor blood has been screened using NAT.

     

    Application in Low-Resource Settings
    Centralized laboratory services are not widely accessible in low-resource settings. Rapid, point of care HIV tests have become increasingly popular, with the vast majority of them detecting only antibodies. These disposable tests do not require power or other infrastructure, and are relatively easy to use. Once the finger has been pricked, blood is transferred to the test well using a disposable capillary tube. A few drops of chase buffer follow the blood sample onto the immunochromatographic strip. Test results are typically visible without any further equipment in 30 minutes or less.  In many countries, the test is available at no charge to the patient, and especially to pregnant mothers coming for antenatal care.

    REPRESENTATIVE PRODUCTS

    MAKE
    MODEL
    PRICE
    TECH
    STATUS
    NOTES

    Multigene

    Gradient
    $5,500
    NAT
    Marketed
    PCR used for NAT

    Immucor

    8441-01
    $1,500
    ELISA
    Marketed
    Microplate washer used for ELISA

    Orasure

    Oraquick Advance
    $10.00
    Saliva rapid test
    Marketed
    FDA approved oral fluid test

    ChemBio

    HIV1/2 STAT-PAK
    $1.50
    Blood rapid test
    Marketed
    FDA approved, widely used

    KHB

    HIV (1+2)
    $1.00
    Blood rapid test
    Marketed
    Not FDA approved, widely used

    * Prices are approximated. Actual pricing can, and will vary by marketplace and market conditions.

  • CHARACTERISTICS OF REPRESENTATIVE PRODUCT

    TECHNOLOGY CHARACTERISTICS

    OPERATIONAL PARAMETERS

    POTENTIAL OPPORTUNITIES FOR IMPROVEMENT

    SKILLS

    REQUIRED

    Intended end user
    Training required
    Time required per use
    Physician, nurse, technician
    Hours
    4-30 minutes

    At this price point, the test is remarkably simple and easy to use.

    ENVIRONMENT/ INFRASTRUCTURE

    Power required
    Waste collection
    Complementary technologies required
    Temperature and storage
    Maintenance
    None
    Biohazard
    Antiseptic wipe, lancet, gloves, timer, capillary tubes
    4-30ÂșC
    None

    COST

    Device Cost (Approx)
    Cost/use (Approx)
    $1.00
    $1.00

    OTHER

    Portability
    Regulatory
    Efficacy
    <100g

    Additional devices required for impact: In the event of a positive result, a confirmatory test is recommended. If HIV is confirmed, the patient must be referred for counseling and treatment.

Sources: USAID - From the American People. HIV Test Kits Listed in the USAID Source and Origin Waver. Arlington: Rational Pharmaceutical Management Plus Program. 2009. J Greenwald et al. A Rapid View of Rapid HIV Tests. Curr Infect Dis Rep. 2006 Mar;8(2):125-31. WM Dolmans et al. Feasibility and costs of ELISA versus rapid assays for HIV screening of donor blood in rural hospitals in Tanzania. Int Conf AIDS. 1992 Jul 19-24; 8: C317 J Pavie et al. Sensitivity of Five Rapid HIV Tests on Oral Fluid or Finger-Stick Whole Blood: A Real-Time Comparison in a Healthcare Setting. PLoS ONE 5(7). 2010. Tudor Car L, van-Velthoven MHMMT, Brusamento S, Elmoniry H, Car J, Majeed A, Atun R. Integrating prevention of mother-to-child HIV transmission (PMTCT) programmes with other health services for preventing HIV infection and improving HIV outcomes in developing countries. Cochrane Database of Systematic Reviews 2011, Issue 6. Art. No.: CD008741. DOI: 10.1002/14651858.CD008741.pub2.