Monkeypox Virus Antibody Test Kit ((Dry Color Latex Immunoassay)

[INTENDED USE]
The Monkeypox Virus Antibody Test is used to detect monkeypox virus
antibodies in blood samples from patients suspected of having monkeypox
virus after the onset of symptoms and can be used as a clinical aid in the
diagnosis of monkeypox virus infection.
[TEST PRINCIPLE]
During the test, a specimen is dropped into the hole, and then the specimen
is superimposed under the capillary effect. If the specimen contains
monkeypox virus antibody, A color band appears in the test area (T) indicate
a positive result for monkeypox virus antibody. If the specimen does not
contain the corresponding substance to be tested, there will be no color
bands in the test area (T), and the result will be negative. A color band
appears in the quality control area (C) regardless of whether the
corresponding substance to be tested is present in the specimen. The color
band in the quality control area (C) is the standard to determine whether
there are enough specimens and whether the chromatographic process is
normal, and also serves as the internal control standard of the test.
[MAIN COMPONENTS]
1. Monkeypox Virus Antibody test strip in a sealed pouch with
desiccant...25 tests/50tests
2. Sample diluent.................................................................1piece
3. User Manual.....................................................................1 piece
Note: Do not mix or interchange different batches of kit.
[STORAGE AND VALIDITY]
Store the test kit at 4°C-30°C, with a valid period of 18 months.
Test strip is individually packaged. Test strip should be used within 1 hour
once the foil pouch is opened.
[SAMPLE REQUIREMENTS]
Used for human serum, plasma,whole blood, Fingertip blood. Other
bodily fluids and samples may not get the accurate result.
Serum can be vascularized in a vacuum without anticoagulant.
Pasma can be anticoagulant with EDTA、Heparin and sodium citrate.
1. The sample should be tested immediately after being collected.
The sample to be measured can be stored at 2°C-8°C for 3 days if
they cannot be tested immediately. For long-term storage, it should
be placed at -20°C. Samples should avoid repeated freezing-
thawing.
2. In order to ensure the accuracy of the result, the sample with large
amount of lipid, hemolysis or turbidity should not be used. The
sample with microbial contamination should be avoided.
3. The frozen samples should be completely melted and mixed evenly
before use. Repeated freezing-thawing should be avoided. It is
recommended that the freezing-thawing of the sample should not be
more than one time. If there is sediment in the thawed sample, the
sample should be centrifuged before testing.

1. Preparation
The test strip, sample and sample diluent should be recovered to room
temperature (15°C-30°C) before testing.
2. Add the sample
Deliver 5μL of sample into the sample port of the test strip and add
four drops of sample diluent (100μL-140μL) to the sample port
immediately, then start timing. It should be ensured that no bubbles
are generated during the operation.
3. Observe results after 15min