BioPlex® 2200 HIV Ag-Ab

Print

Overview

HIV Serological Profile

Serological Detection of HIV Infection
There are many methods for detecting HIV. The most common is the serological detection of HIV infection over the infection stages: eclipse period, acute infection, and established infection.

Branson, Bernard M, et. all, Centers for Disease Control and Prevention (US),
Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations, June 27, 2014.

 

 

 

HIV Testing Generations

HIV Generation Testing for Screening
1st Generation: Viral Lysate, IgG Ab detection
2nd Generation: Recombinant / Synthetic Peptides, HIV-1/2 IgG Ab detection
3rd Generation: Recombinant / Synthetic Peptides, HIV-1 Ab (Groups M and O), IgG and IgM Ab detection
4th Generation: 3rd Gen assay design + HIV-1 p24 Ag detection
       •  Detects HIV-1, Group O, and HIV-2 IgG and IgM antibody
       •  Detects HIV-1 p24 antigen to detect infection about 7 days earlier than third generation tests

       Limitations
       •  Results are only Reactive and Non-Reactive for an overall result without individual results
       •  Primary infection samples are detected but not distinguished from late infection
       •  HIV-2 reactives can only be differentiated from HIV-1 reactives during confirmation
       •  Confirmation testing can be complex

 

 

BioPlex® 2200 HIV Ag-Ab Test System

The Next Generation in HIV Testing —
The 5th Generation BioPlex 2200 HIV Ag-Ab assay design

Enhanced sensitivity combined with the ability to simultaneously detect and report an overall result with 3 individual HIV results:

       •  HIV Ag-Ab overall result
       with
       •  HIV-1 p24 Ag
       •  HIV-1 Ab (Groups M & O)
       •  HIV-2 Ab

Separate reporting of HIV-1 p24 Ag to help identify acute infections.
Includes HIV-1 and HIV-2 Ab Differentiation.

Assay Principle

The 5th generation assay design allows for the simultaneous detection and identification of multiple HIV analytes for each sample processed. The bead reagent consists of a mixture of four distinct populations of dyed microparticle beads, in addition to three internal quality beads that assure quality results.

 

HIV Clinical Overview

What is HIV?
H – Human: This particular virus can only infect human beings.
I – Immunodeficiency: HIV weakens the immune system by destroying important cells that fight disease and infection. A 'deficient' immune system can't protect the body.
V – Virus: A virus can only reproduce itself by taking over a cell in the body of its host.

 

What is AIDS?
A – Acquired: AIDS is not something you inherit. You acquire AIDS.
I – Immune: The body's immune system includes all organs and cells that work to fight off infection or disease.
D – Deficiency: One gets AIDS when the immune system is 'deficient,' or isn't working the way it should.
S – Syndrome: A syndrome is a collection of symptoms and signs of disease. AIDS is a syndrome, rather than a single disease, because it is a complex illness with a wide range of complications and symptoms.

AIDS is the late / final stage of HIV infection. At this stage of HIV disease, the immune system is severely damaged and has difficulty fighting diseases and certain cancers.

 

How does one get HIV?
HIV is found in specific human body fluids. HIV lives and reproduces in blood and other body fluids. The following fluids can contain high levels of HIV:

  • Blood
  • Pre-seminal fluid
  • Vaginal fluids
  • Semen
  • Breast milk
  • Rectal (anal) mucous

 

Early Stage of HIV: Symptoms
Within 2-4 weeks after HIV infection, many people, but not all, experience flu-like symptoms, often described as the “worst flu ever.” This is called “acute retroviral syndrome” (ARS) or “primary HIV infection,” and it’s the body’s natural response to HIV infection.

Symptoms can include:

  • Fever (this is the most common symptom)
  • Swollen glands
  • Sore throat
  • Rash
  • Fatigue
  • Muscle and joint aches and pains
  • Headache

 

Symptoms can last anywhere from a few days to several weeks.

Many people infected with HIV do not have any symptoms for 10 or more years.   Symptoms alone can not determine if one is infected with HIV. The only way to know is with a test.

Source: Adaptated from AIDS.gov

 

 



INTENDED USE

The BioPlex® 2200 HIV Ag-Ab assay is a multiplex flow immunoassay intended for the simultaneous qualitative detection and differentiation of the individual analytes HIV-1 p24 antigen, HIV-1 (groups M and O) antibodies, and HIV-2 antibodies in human serum or plasma (fresh or frozen K2 EDTA, K3 EDTA, lithium heparin, sodium heparin; fresh citrate). This kit is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2, including acute (primary) HIV-1 infection. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects as young as two years of age, and pregnant women.

The BioPlex HIV Ag-Ab assay is also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating.

The BioPlex® 2200 HIV Ag-Ab assay is not intended for use in screening blood or plasma donors, as the effectiveness of this test for use in the screening of these donors has not been established. However, in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical, this assay can be used as a blood donor screening assay.

The BioPlex® 2200 HIV Ag-Ab assay is intended for use with the BioPlex® 2200 System.

WARNING

FDA has approved this test for use with serum and plasma specimens only. Use of this test kit with specimens other than those specifically approved for use with this test kit may result in inaccurate test results. This test is not intended for use in children younger than 2 years of age.

CAUTION

United States federal law restricts this device to sale by or on the order of a physician, or to a clinical laboratory.

PRODUCT DESCRIPTION

The BioPlex® 2200 HIV Ag-Ab multiplexed kit is Bio-Rad’s next (5th) generation HIV test system.

The 5th Generation BioPlex 2200 HIV Ag-Ab assay design simultaneously detects and reports:
•  HIV Ag-Ab overall result
  with
•  HIV-1 p24 Ag
•  HIV-1 Ab (groups M & O)
•  HIV-2 Ab
 
Separate reporting of HIV-1 p24 helps identify acute infections.
Includes HIV-1 and HIV-2 Ab Differentiation.

Excellent overall performance:
•  Best Analytical Sensitivity on the market today for HIV-1 p24 Ag:
  Limit of Detection (LOD) = 0.33 IU/mL and 5.2 pg/mL
•  Seroconversion Panels: Detection earlier in 7 of 42 panels, later in 1 when compared to 4th generation assays
•  High Reproducibility: Total CV’s of 4.5 – 11.7%
•  High Specificity: Low Risk Population- 99.86%
•  Differentiates Between HIV-1 and HIV-2 Ab: 100% capability rate for HIV-1; 94.0% capability rate for HIV-2

Organ Donor Screening Claim:
•  100% Sensitivity and Specificity
  The only US HIV diagnostic kit on the market with this screening indication

Guides supplemental testing
Knowing which analytes are detected can help identify which supplemental testing to perform.
x

Account price failed to display. Please try reloading the page. Reload Page

If you are placing an order, you may proceed with your order; the account price will be applied if it is lower than the
list price. If the problem persists, please call customer service at   or send an
email to 

Waste Electrical and Electronic Equipment ("WEEE Directive")

This product contains electrical or electronic material. Learn more about Bio-Rad's EU Recycle Program

Waste Electrical and Electronic Equipment ("WEEE Directive")

This product contains electrical or electronic material. Learn more about Bio-Rad's EU Recycle Program

Waste Electrical and Electronic Equipment ("WEEE Directive")

This product contains electrical or electronic material. Learn more about Bio-Rad's EU Recycle Program

Waste Electrical and Electronic Equipment ("WEEE Directive")

This product contains electrical or electronic material. Learn more about Bio-Rad's EU Recycle Program

Waste Electrical and Electronic Equipment ("WEEE Directive")

This product contains electrical or electronic material. Learn more about Bio-Rad's EU Recycle Program

BioPlex® 2200 HIV Ag-Ab Reagent Kit

665-3455
Reagents for 200 samples for multiplex detection and differentiation of HIV-1 p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 on the BioPlex® 2200 System

List Price:
 
Inquire
LoadingLoading...
Your Price:
 

Communication error

Reload Page

Quantity:   Add to Quote
Add to Hot List  
BioPlex® 2200 HIV Ag-Ab Calibrator Set

663-3405
Three sets of multiplexed standard analytes for calibration of results of HIV-1 p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 on the BioPlex® 2200 System

List Price:
 
Inquire
LoadingLoading...
Your Price:
 

Communication error

Reload Page

Quantity:   Add to Quote
Add to Hot List  
BioPlex® 2200 HIV Ag-Ab Control Set

663-3435
Three sets of multiplexed negative and positive controls for multiplex detection and differentiation of HIV-1 p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 on the BioPlex® 2200 System

List Price:
 
Inquire
LoadingLoading...
Your Price:
 

Communication error

Reload Page

Quantity:   Add to Quote
Add to Hot List  
BioPlex® 2200 HIV Ag-Ab Calibrator Set CD

663-3420
Calibrator set CD for the BioPlex® 2200 HIV Ag-Ab test kit (1 CD)

List Price:
 
Inquire
LoadingLoading...
Your Price:
 

Communication error

Reload Page

Quantity:   Add to Quote
Add to Hot List  
BioPlex® 2200 HIV Ag-Ab Control Set CD

663-3440
Control set CD for the BioPlex® 2200 HIV Ag-Ab test kit (1 CD)

List Price:
 
Inquire
LoadingLoading...
Your Price:
 

Communication error

Reload Page

Quantity:   Add to Quote
Add to Hot List  
Number Description Options
T-255 BioPlex 2200 HIV Ag-Ab Sales Sheet Click to download