Alere Determine HIV-1/2

Determin HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of Human Immunodefciency Virus Type 1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV Type 1 and Type 2 (HIV-1 and HIV-2) in human serum, plasma, capillary (fngerstick) complete blood or venipuncture (venous) complete blood. It is supposed to be used as a pointof-care check to resource withinside the prognosis of contamination with HIV-1 and HIV-2, consisting of an acute HIV-1 contamination, and might distinguish acute HIV-1 contamination from installed HIV-1 contamination whilst the specimen is high-quality for HIV-1 p24 antigen and bad for anti-HIV-1 and anti-HIV-2 antibodies. The check is appropriate to be used in multi-check algorithms designed for the statistical validation of speedy HIV check results. When more than one speedy HIV check are available, this check may be utilized in suitable multi-check algorithms.

SUMMARY of DEVICE DESCRIPTION and BIOLOGICAL PRINCIPLE of the PROCEDURE

Determine HIV–1/2 Ag/Ab Combo is an immunochromatographic check for the simultaneous and separate qualitative detection of loose HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2. The check tool is a laminated strip that includes a pattern pad containing monoclonal biotinylated anti-HIV-1 p24 antibody, a conjugate pad containing monoclonal anti-HIV-1 p24 antibodycolloidal selenium and HIV-1 and HIV-2 recombinant antigen-colloidal selenium, and a nitrocellulose membrane with an immobilized combination of recombinant and artificial peptide HIV-1 and HIV-2 antigens withinside the Lower Test Area, immobilized streptavidin withinside the Upper Test Area, and an immobilized combination of anti-HIV-1 antibody, HIV-1/2 antigens, and HIV-1 p24 recombinant antigen and anti-HIV-1 p24 monoclonal antibody withinside the Control Area.

A specimen (venipuncture or capillary complete blood, serum, or plasma) is implemented to the pattern pad (accompanied through chase bufer for venipuncture or fngerstick complete blood specimens) and migrates through capillary movement thru the conjugate pad after which thru the nitrocellulose membrane. If HIV-1 p24 antigen is gift withinside the specimen, it binds with the monoclonal biotinylated anti-HIV-1 p24 antibody from the pattern pad after which with monoclonal anti-HIV-1 p24 antibody-colloidal selenium from the conjugate pad to shape a complicated (biotinylated antibody-antigen-colloidal selenium-antibody). This complicated migrates thru the stable segment through capillary movement till it’s miles captured through immobilized streptavidin on the Upper Test Area (labeled “Ag”) wherein it paperwork a unmarried pink/purple “Ag” line. If HIV-1 p24 antigen isn’t gift withinside the specimen or is under the restriction of detection of the check, no pink/purple Ag line is formedIf antibodies to HIV-1 and/or HIV-2 are gift withinside the specimen, the antibodies bind to recombinant gp41 (HIV-1) and gp36 (HIV-2) antigen-colloidal selenium conjugates from the conjugate pad. The complicated migrates thru the stable segment through capillary movement till it’s miles captured through immobilized HIV-1 and HIV-2 artificial peptide antigens and recombinant gp41 antigen on the Lower Test Area (labeled “Ab”) and paperwork a unmarried pink/purple “Ab” line. If antibodies to HIV-1 and/or HIV-2 are absent or are under the detection restriction of the check, no pink/purple Ab line is fashioned.

To make certain assay validity, a procedural “Control” line containing a combination of anti-HIV-1 antibody, HIV-1/2 antigens, and HIV-1 p24 recombinant antigen and anti-HIV-1 p24 monoclonal antibody is integrated withinside the nitrocellulose membrane. For a check end result to be legitimate there ought to be a seen pink/purple Control line. During the checking out system the colloidal selenium conjugates launched from the conjugate pad might be captured through the antibodies and antigens immobilized withinside the Control Area and shape a pink/purple Control line for samples which might be both high-quality or bad.

NOTE: A pink/purple Control line can also additionally seem even if a check pattern has now no longer been implemented to the check unit.

COMPONENTS of DETERMINE™ HIV-1/2 Ag/Ab COMBO: MATERIALS PROVIDED

  • Aluminum ziplock pouch containing Determine HIV-1/2 Ag/Ab Combo Cards. Each card includes five or 10 check gadgets which may be separated from every different through tearing alongside the perforated lines. Each check unit has a cowl this is to be eliminated for pattern software and visualization of check results.
  •  Desiccant bundle
  •  Chase bufer: Containing sodium chloride, disodium hydrogen phosphate, and Nipasept as a preservative.
  •  Quick reference card
  •  Package insert
  • Subject data notices
  •  Customer letter
  • Disposable capillary tubes: 25. For series and switch of fngerstick samples.
  •  Disposable workstations: 25

MATERIALS REQUIRED and AVAILABLE as an ACCESSORY to the KIT Determine

HIV–1/2 Ag/Ab Combo Controls (Catalog #7D2628). Each bundle contains: –

HIV-1 p24 antigen control:1.5 mL, HIV-1 viral lysate in defbrinated pooled everyday human plasma; bad for antibodies to HIV-1, HIV-2 and HCV; bad for HBsAg. – HIV-1 reactive control: 1.five mL, human plasma high-quality for anti-HIV-1 antibodies, diluted in defbrinated pooled everyday human plasma; bad for antibodies to HIV-2 and HCV; bad for HBs Ag.  – HIV-2

reactive control: 1.5 mL, human plasma high-quality for anti-HIV-2 antibodies, diluted in defbrinated pooled everyday human plasma; bad for antibodies to HIV-1 and HCV; bad for HBsAg and HIV-1 p24. –

Nonreactive control: 1.5 mL, defbrinated everyday human plasma; bad for antibodies to HIV-1, HIV-2, and HCV; bad for HBsAg and HIV-1 p24. – forty Disposable pipettes – to be used checking out the outside controls only. The disposable pipettes aren’t for use for checking out affected person samples.

Collection gadgets for specimens (apart from fngerstick complete blood specimens)

  • Sterile lancet able to generating 50 µL of blood Serum and plasma specimens can be saved at room temperature (15- 30°C) for up to 2 days earlier than checking out.
  • If checking out will now no longer be executed inside days of pattern series, serum and plasma specimens have to be saved at 2- 8°C if the check is to be run inside 7 days of series. If checking out is behind schedule extra than 7 days, the specimen have to be frozen (-20°C or colder).
  • Mix specimen properly through mild inversion of the tube without delay earlier than checking out.
  • Avoid repeated freeze/thaw cycles. Specimens which have been frozen and thawed extra than three instances can not be used.
  •  All frozen specimens ought to be centrifuged at 10,000g for five min at room temperature. Carefully dispose of the 50 μL check pattern from the supernatant. If a lipid layer is fashioned at the floor of the liquid, make certain that the pattern is taken from the clean liquid under that layer.

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Whole blood accrued through venipuncture can be saved at room temperature (15- 30°C) for up to 2 days earlier than checking out. If checking out will now no longer be executed inside days of pattern series, complete blood accrued through venipuncture have to be saved at 2- 8°C if the check is to be run inside 6 days of series. Do now no longer freeze complete blood specimens. If saved at 2- 8°C, bring specimen to room temperature earlier than checking out. Mix specimen properly through mild inversion of the tube without delay earlier than checking out. Whole blood accrued through fngerstick have to be examined without delay

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