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Hanta RAPID

Configuration

  • 30 tests/kit box
  • 2 bottles of sample diluent
  • 2 explanatory sheets
  • 2 test procedure sheets

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Benefits & effects

Furthermore, the Hanta Rapid kit provides rapid interpretation (10 minutes) and can detect IgM and IgG antibody simultaneously which helps to not only be useful for the follow up of the degree of the disease but also estimate reinfection and residual antibody as well.

Product Information

“ImmuneMed Hanta Rapid” tests the antibodies against Hantaan and Seoul virus from the patient’s blood using Lateral-Flow Immuno chromatography Assay for the diagnosis of Hemorrhagic Fever with Renal Syndrome (HFRS) by these viruses.

After applying the diluted serum, plasma or blood onto the hole of testing device, lgM antibody of this specimen first reacts with gold conjugated animal anti-human lgM and lgG antibody of this does gold conjugated protein A. Each reactant diffuses on the membrane to recombinant antigen bound to the T (test) line.
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Features

1. Testing Device

One round hole for sample applying on the white plastic cassette and two detection windows for IgM and IgG. The control and test lines are located on the detection windows. Included in the kit - a sample pad, a reddish conjugate pad, a white nitrocellulose membrane and an absorption pad are piled in order.

2. Sample Diluents

Colorless liquid in the semi-transparent plastic bottle.

3. Purpose

Qualitative test for the antibody against Hantaan and Seoul virus from patient's whole blood, serum or plasma.
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Materials and Methods

1. Specimen

  • Use serum, plasma or whole blood as specimen.
  • Collected blood containing anti-coagulant should be used immediately or the blood kept in 2~8℃ for 3 days is possible to use.
  • Separated serum and plasma could be used until one month if kept in 2~8℃ or 1 year if kept frozen.

2. Testing Method

  • If each specimen and reagent is kept frozen, place it for 30 min at room temperature before use.
  • After pulling out the testing cassette from the closed pouch, place it to the flat position.
  • In case of serum or plasma, 3 ㎕ is diluted about 100 fold with 300 ㎕ sample diluent. If using whole blood, take 6 ㎕ and it is diluted about 50 fold with 300 ㎕ sample diluent. After that, apply 300 ㎕ of this diluted sample to the hole. * Or when 3 ㎕ of serum or plasma, or 6 ㎕ of whole blood are directly applied to the sample pad in the hole, immediately add 7 drops of sample diluent provided.
  • Wait for 15 min until the red line appears on the control line. Read and interpret the result exactly after 15 min from applying the diluted sample. Ignore the red line appeared after 15 min for interpretation.

3. Interpretation

  • Positive: Red line must appear on each C line of IgM and IgG in the detection windows and one or two red lines should appear on the test line, T in the windows. (Fig 1. a,b,c).
  • Negative: Red lines only appear on both control lines of IgM and IgG in the detection windows and no red line should appear on the test line, T. (Fig 1. d).
  • If red line does not appear from at least one out of 2 C lines, this result is interpreted as invalid and the test must be done again. (Fig 1. e).

4. Quality Control

Red lines should appear on both control lines for all IgM and IgG testing.

Precautions

  • It is used only for in vitro diagnosis.
  • Due to the deterioration in quality when testing device is exposed to moisture in storage, take out the device from the sealed pouch right before the use and use it within 30 minutes.
  • Do not touch by hands or have direct contact to the membrane of the detection window of this kit as the test result may be affected.
  • Avoid moisture, direct sunlight, heat and keep it in room temperature.
  • Do not use the kit after the expiration date.
  • If the testing result of test line is positive, it means the antibody is positive against Orientia tsutsugamushi. This kit should be used as the first time diagnosis only. The confirmation test would be necessary if positive and the final diagnosis should be made by a professional doctor after analyzing this test result and other clinical data in conjunction with inquiries.
  • Precautions of specimen handling and storage
    • Contaminated or heated specimen should not be used for testing.
    • Be careful that serious haemolysis or microbial contaminated specimen may cause inaccurate result.
    • Be careful with handling specimens which may impregnate dangerous sources of unknown viral or bacterial infection. Use disposable gloves when handling the specimen and wash your hands after handling.
    • Solid and liquid waste from experiments should be discarded after high-pressure autoclaving for 15 minutes or more at 121℃ .