Monkeypox Virus Antibody Test Kit (Dry Fluorescence 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. Positive and negative results in
suspected persons should be subjected to further nucleic acid testing.
[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 pieces
2. Sample diluent.................................................................1 bottle
3. QR code card for calibration..........................................1 piece
4. 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.
[APPLICABLE DEVICES]
1. LS-1000 Dry Fluorescence ImmunoassayAnalyzer
2. LS-2000 Dry Fluorescence ImmunoassayAnalyzer
3. LS-1100 Dry Fluorescence ImmunoassayAnalyzer
4. LS-2100 Dry Fluorescence ImmunoassayAnalyzer
5. LS-4000 Dry Fluorescence Immunoassay Analyzer (Handheld)
6. LS-7000 Fluorescence Immunoassay Analyzer
[SAMPLE REQUIREMENTS]
1. Used for human serum, plasma,whole blood, Fingertip blood. Other
bodily fluids and samples may not get the accurate result.
2. Serum can be vascularized in a vacuum without anticoagulant.
3. Pasma can be anticoagulant with EDTA、Heparin and sodium citrate.
4. 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.
5. 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.
6. 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.
[TEST PROCEDURE]
1. Preparation
The test strip, sample and sample diluent should be recovered to room
temperature (15°C-30°C) before testing.
2. Calibration
Turn on the device and insert the calibration curve by scanning the QR
code of the test kit to complete the calibration.
3. 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.
4. After 15 minutes, insert the test strip with sample mixture into the
device for testing (for details, see the device operating instructions).
5. The device performs analytical testing and displays the results.
6. Remove the used test strip.
7. Quality control: the test kit doesn’t include controls.
[INTERPRETATION OF RESULT]
1. Monkeypox virus antibodies＜1.00, it indicates that the antibody
test is negative. Monkeypox virus antibodies≥1.00, it indicates that
the antibody test is positive.
If the test is positive, other tests will be recommended to confirm
diagnosis.
2. The test kit can’t exclude the possibility of false positive completely
due to the specificity of the antigen and antibody in the sample and
the differences in the complex structure of biologically active
substances. The result of the test should be evaluated in the context
of all the clinical and laboratory data available. In those instances
where the laboratory results do not agree with the clinical evaluation,
additional tests should be performed accordingly.

[LIMITATION]
1)The positive results of Monkeypox Virus Ab Test cannot exclude the
infection of other pathogens other than Monkeypox Virus.
2) Monkeypox Virus Ab Test can only qualitatively detect monkeypox virus
antibody in the specimen, and cannot indicate the content of the antibody
in the specimen.
3) Monkeypox Virus Ab Test is only used for preliminary screening. If it is
necessary to confirm the diagnosis, clinical symptoms or further laboratory
tests should be performed
[PRODUCT PERFORMANCE]
1. Negative reference rate: the company's negative reference rate
should be 10/10.
2. Positive reference rate: The corporate positive reference rate should
be 5/5.
3. LoD：When tested with the corporate detection limit reference, SL1
and SL2 monkeypox virus antigens are detected as positive and SL3
monkeypox virus antigens are detected as negative.
4. Reproducibility: The two monkeypox virus antigens corporate
precision reference products (SR1 and SR2) are tested and each is
repeated 10 times and the results are positive.
5. Between-batch precision：Three batches of kits were taken, and two
Monkeypox virus antigen corporate precision reference products (SR1
and SR2) were tested, and each was repeated 10 times with a CV less
than 20%.
[PRECAUTIONS]
1. : In vitro diagnostic medical device.
2. After the test strip is removed from the sealed pouch, it should be
tested as soon as possible to avoid excessive time in the air,
resulting in dampness.
3. The damaged test strip or package cannot be used.
4. Do not mix the components of different kits.
5. All samples from patients should be treated as potential sources of
infection.
6. Used strips should be properly disposed according to local
regulations to avoid contamination.