Comparison of Plasma & SMARTplasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) Antibody Testing
Condition: Human Immunodeficiency Virus Infection; Hepatitis C
MeSH terms: Infections; Hepatitis A; Hepatitis C; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to compare the results for HIV and/or Hepatitis C Virus antibody
      testing when using routine plasma versus SMARTplasma from the same blood sample. SMARTplasma
      is enriched for antibodies via a stimulation step of whole blood in a SMARTube™ (SMARTstim™
      in the USA).
    

Detailed description: 
      Following exposure to HIV and HCV, there is a "window period" where a person is infected with
      the virus but does not produce antibodies at a high enough level so they can be detected by
      antibody detection test methods. During this time, the person is capable of unknowingly
      transmitting the virus to others. SMARTstim (SMARTube)is a blood sample additive which
      pre-treats blood, stimulating antibody production in vitro so as to bring it to detectable
      levels using ELISA (or any other antibody test method). Accelerated antibody production
      allows antibody detection in specimens that would otherwise be below the detectable limit of
      antibody test kits. Plasma samples from blood pretreated with SMARTstim are referred to as
      "SMARTplasma".

      A total of 1,600 blood samples will be collected and tested using an ELISA for HIV and HCV
      using FDA-approved test kits. The populations include:

        -  1000 samples from low risk individuals (blood donors) from 3 geographical locations

        -  500 samples from high risk individuals at risk for HIV from 2 geographical locations

        -  100 known HIV seropositives

      This is a non-linked study; that is, no subject identifiers will be associated with the
      collected blood. Subjects will not receive any correspondences and will not receive any test
      results.

      If discordant results occur between the plasma and SMARTplasma samples, those samples will be
      retested. A Western Blot will be performed on ELISA repeat reactive discordant samples. HCV
      testing using an FDA-approved assay may also be performed using retained samples.

      Simple statistical methods will be performed as necessary to analyze concordance of results
      between the sample types in the same ELISA assay.

      Secondarily, it is expected that within the scope of this study, it will be shown that:

        -  Using SMARTplasma does not adversely affect diagnostic specificity of the HIV and/or HCV
           antibody assay used; i.e., no increase in the rate of HIV or HCV false positive results.

        -  Using SMARTplasma does not adversely affect diagnostic sensitivity of the HIV and/or HCV
           antibody assay used; i.e., no decrease in the number of true positive samples.

        -  Samples from persons with early or acute infection may show a positive result when using
           SMARTplasma, while those from plasma will test negative.

        -  SMARTplasma samples using heparin or EDTA collection tubes and the correlating SMARTstim
           are comparable.

        -  SMARTplasma samples that have been frozen show comparable results to correlating
           SMARTplasma samples that have been refrigerated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Laboratory Sample from low risk population (i.e., blood donors), high risk population and
        known positive patients.
      
Biospecimen description: 
      Plasma and SMARTplasma (SMARTplasma is plasma sample from whole blood treated with SMARTstim)
    
Keywords: HIV infection; HCV infection; SMARTube; SMARTplasma