INTENDED USE
The Chikungunya IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG/IgM anti-chikungunya virus (CHIK) in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with CHIK. Any reactive specimen with the Chikungunya IgG/IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.
INTRODUCTION
Chikungunya is a rare viral infection transmitted by the bite of an infected Aedes aegypti mosquito. It is characterized by a rash, fever, and severe joint pain (arthralgias) that usually lasts for three to seven days. The name is derived from the Makonde word meaning "that which bends up" in reference to the stooped posture developed as a result of the arthritic symptoms of the disease. It occurs during the rainy season in tropical areas of the world, primarily in Africa, South-East Asia, southern India and Pakistan[1-2]. The symptoms are most often clinically indistinguishable form those observed in dengue fever. Indeed, dual infection of dengue and chikungunya has been reported in India. Unlike dengue, hemorrhagic manifestations are relatively rare and most often the disease is a self limiting febrile illness. Therefore it is very important to clinically distinguish dengue from CHIK infection. The Chikungunya IgG/IgM Rapid Test detects IgM anti-CHIK in patient serum, plasma or whole blood within 10 minutes. The test can be performed by untrained or minimally skilled personnel, without cumbersome laboratory equipment.
SUMMA
TEST PROCEDURE
Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
1. Remove the test device from the sealed pouch and Place the test device on a clean and level surface.
For Serum or Plasma Specimens:
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 µL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of Assay buffer (approximately 90 mL) and start the timer. Avoid trapping air bubbles in the specimen well (S).
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10 µL) to the specimen well (S) of the test device, then add 3 drops of Assay buffer (approximately 90 µL) and start the timer.
To use a micropipette: Pipette and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer.
2.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
IgG POSITIVE:* Purplish red line appears in control line region (C), and purplish red line appears in test line region (G). The result is positive for Chikungunya specific-IgG and is probably indicative of secondary Chikungunya infection.
IgM POSITIVE:* Purplish red line appears in control line region (C), and purplish red line appears in test line region (M). The result is positive for Chikungunya specific-IgM antibodies and is indicative of primary Chikungunya infection.
IgG AND IgM POSITIVE:* Purplish red line appears in the control line region (C), and two Purplish red lines should appear in the test line region G and M, and the color intensity of the lines need not match. Resulting the IgG and IgM antibodies were positive, indicating the presence of anti-Chik IgG and IgM in the specimens.
NEGATIVE: Purplish red line appears in the control line region (C). No lines appear in the test line region G and M.
INVALID: No line appears on control line(C).
ABOUT US
Hangzhou lmmuno Biotech Co., Ltd is the original organization in lmmuno Group, which has engaged in this industry for more than 10 years. The team of Hangzhou lmmuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage.In the past few years we focused on the human medical diagnostic field which mainly cover the following directions: rapid tests for vector-borne diseases(VBDs), rapid tests for sexually transmitted diseases (STDs), rapid tests for respiratory system diseases, rapid tests for digestive system diseases and rapid test for drug of abuse. For now, we are paying more attention to the diagnosis of neglected tropical diseases (NTDs). With strong R&D ability we are capable to develop and produce test kits for customers in a short time, and our product quality is ahead of similar products in the market.
