PACKAGING SPECIFICATIONS
1 test/box, 5 tests/box, 20 tests/box

MATERIALS SUPPLIED
Each sealed pouches contains a test cassette, a desiccant, a dropper, Buffer, Package insert

Intended Use

Monkeypox virus IgG/IgM Test Kit (lmmunochromatography) is a solid phase immunochromatographic assay for the rapid, qualitative detection of lgG/IgM antibody to Monkeypox virus in human blood.This test provides only apreliminary test result. Therefore, any reactive specimen with the Monkeypox virus lgG/IgM Test Kit (lmmunochro-matography) must be confirmed with alternative testing method(s) and clinical findings.

Introduction

Monkeypox is a viral zoonosis (a virus transmitted to humans from animals) with symptoms very similar to those seen in the past in smallpox patients, although it is clinically less severe. With the eradication of smallpox in 1980 and subsequent cessation of smallpox vaccination, monkeypox has emerged as the most important orthopoxvirus for public health. Monkeypox primarily occurs in Central and West Africa, often in proximity to tropical rainforests and has been increasingly appearing in urban areas. Animal hosts include a range of rodents and non-human primates.

Principle

Monkeypox vius lgG/IgM Test kit (lmmunochromatography) uses the principle of immuno-chromatography. The test uses anti-human lgM antibody (test line lgM), ant-human lgG (test line lgG) and goat anti-mouse lgG(control line C) immobilised on a nitrocellulose membrane. The conjugate pad contains microsphere conjugated to recombinant Mankeypox antigens conjugated with microsphere.When a specimen followed by assay buffer is added to the sample well, IgM &/or lgG antibodies if present, will bind to Monkeypox conjugates making antigen antibodies complex. This complex migrates through nitrocellulose membrane by capillary action.When the complex meets theline of the corresponding immcbilized antibody (anti-human IgM&/or anit-human lgG) the complex is trapped forming a band which confirm a reactive test result.
Regardless of the presence of Monkeypox lgG/gM antibody in the test sample, a colored band will appear on thequality control line (line C). The colored band appearing on the quality control line (line C) is used to determinewhether there are enough samples and whether the chromatographic process meets the nomal standard, and alsoserves as the internal control standard of the reagent.

STORAGE CONDITIONS AND VALIDITY PERIOD
The test kit should be stored in a sealed aluminum foil bag at 4ºC ~30ºCC, and the validity period is 24 months. Afterthe foil bag is opened, the validity period is 1 hour.

TEST METHOD
Allow test cassette, specimen, buffer and/or controls to equilibrate to room temperature prior to testing.
1.Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtainedif the assay is performed within one hour.
2.Place the test device on a clean and level surface.
For Serum or Plasma Specimens:
With the provided dropper, draw serum/plasma specimen and then add 1 drop serumplasma specimen into thesample well(S).Then add 2 drops of buffer to the sample well(S) immediately. Avoid air bubbles.
For Whole Blood Specimen:
With the provided dropper and transfer 1 drop of whole blood to the sample well(S) of the test device, then add 2 drops of buffer to the sample well(S) immediately.  Avoid air bubbles.
Wait for the colored line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 15 minutes.


INTERPRETATION OF RESULTS
NEGATIVE: lf only the C band is present, the absence of any burgundy color in the both T bands (lgG and lgM)indicates that no anti-Monkeypox antibodies are detected in the specimen.The result is negative.
lgM POSITIVE:
ln addition to the presence of C band, if only lgM band is developed, the test indicates for the presence of lgM anti-Monkeypox in the specimen.The result is lgM anti-Monkeypox positive.
lgG POSITIVE:
ln addition to the presence of C band, if only lgG band is developed, the test indicates for the presence of lgG anti-Monkeypox in the specimen. The result is lgG anti-Monkeypox positive.