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AFI RAPID

Configuration

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

 

 

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Benefits & effects

This AFI (Acute Febrile Illness) Rapid kit discriminate Hemorrhagic Fever with Renal Syndrome (HFRS) by Hantaan and Seoul virus, Scrub typhus by Orientia tsutsugamushi and Leptospira by Leptospirosis among AFI(Acute Febrile Illness) as well as provides unique differential detection of lgM and lgG antibodies to AFI pathogens at the same time.Furthermore, this AFI kit provides rapid interpretation (10 minutes) and can detect IgM and IgG antibody simultaneously which not only helps to be useful for the follow up of the degree of the disease but also the estimation of re-infection and residual antibody as well.

Product Information

“ImmuneMed AFI Rapid” tests the antibodies against Hantaan and Seoul virus, Orientia tsutsugamushi (Scrub typhus) and Leptospira from the patient’s blood using Lateral-Flow Immuno Chromatography Assay.

After applying 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 antigens bound to each test line. If positive, the corresponding antigen test line (H, T, L) of Hantaan and Seoul virus, Orientia tsutsugamushi(Scrub typhus) or Leptospira turns to red color because each antigen-antibody complex is forming on the corresponding test line.
afi-rapid

AFI(Acute Febrile Illness) urgently requires accurate differential early diagnosis and proper therapy against different causative microorganisms with similar clinical symptoms.

Features

1. Testing Device

One round hole for sample applying on the white plastic cassette and two detection windows for IgM and IgG. There are 4 different markings, such as C for control line, H for HFRS by Hantaan or Seoul virus, T for Scrub typhus by Orientia tsutsugamushi and L for Leptospira on each detection window.

2. Sample Diluents

Colorless liquid in the semi-transparent plastic bottle.

3. Purpose

Qualitative test for the antibody against Hantaan, Seoul virus, Tsutsugamushi and Leptospirosis 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 15-30 minutes 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 to 300㎕ sample diluents approximately diluted about 100 times. If using whole blood, 6㎕ is diluted to 300㎕ sample diluents. After that, drop the 300㎕ of this diluted sample to the injection opening of the specimen by the Micro Pipette..
  • * Or when in case of 3㎕ of serum or plasma, or 6㎕of whole blood, inject so that it will be absorbed to the sample pad of the injection opening by the Micro Pipette, then immediately add the provided 7 drops of sample diluents.
  • Wait for 5-10 minutes until the red line appears on the control line. Read and interpret the result from 10 to 20 minutes after applying this diluted sample.

3. Interpretation

  • HFRS (Hemorrhagic Fever with Renal Syndrome)
    • Positive: Red lines must appear on both control lines of lgM and lgG in the detection windows and one or two red lines should appear on the test line H in the windows. (Fig1.a, b, c)
    • Negative: Red lines appear only on both control lines of lgM and lgG in the detection windows and no red line should appear on the H line. (Fig1.d)
    • Invalid: If red line does not appear from at least one out of two control lines, this result is interpreted as invalid and the test must be done again. (Fig1.e)
  • Scrub Typhus (Tsutsugamushi disease)
    • Positive: Red lines must appear on both control lines of lgM and lgG in the detection windows and one or two red lines should appear on the test line S in the windows.(Fig2.a, b, c)
    • Negative: Red lines appear only on both control lines of lgM and lgG in the detection windows and no red line should appear on the S line. (Fig2.d)
    • Invalid: If red line does not appear from at least one out of two control lines, this result is interpreted as invalid and the test must be done again. (Fig2.e)
  • Leptospirosis
    • Positive: Red lines must appear on both control lines of lgM and lgG in the detection windows and one or two red lines should appear on the test line L in the windows.(Fig3.a, b, c)
    • Negative: Red lines appear only on both control lines of lgM and lgG in the detection windows and no red line should appear on the L line.(Fig3.d)
    • Invalid: If red line does not appear from at least one out of two control lines, this result is interpreted as invalid and the test must be done again. (Fig3.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℃ .