SARS-CoV-2 Ab Diagnostic Test Kit (Microfluidic Chemiluminescence)
Instructions for Use (IFU)
[Product Name]
1 Generic Name: Novel Coronavirus (SARS-CoV-2) antibody
diagnostic test kit (microfluidic chemiluminescence)
2 English Name: SARS-CoV-2 Ab Diagnostic Test kit
(Microfluidic chemiluminescence)
[Packing Specifications]
10 servings/box, 20 servings/box, 25 servings/box, 30 servings/
box , 40 servings/box, 50 servings/box, 100 servings/box
[Intended Use]
For in vitro quantitative determination of the content of
SARS-CoV-2 antibody in human serum, plasma and whole blood.
Clinically mainly for the auxiliary diagnosis of COVID-19.
[Test Principle]
The SARS-CoV-2 Ab diagnostic test kit (microfluidic
chemiluminescence) has a microfluidic chip and uses magnetic
particles as a solid phase carrier for the immune response to
quantitatively detect the content of SARS-CoV-2 antibody in the
human sample with the immunochemical chemiluminescence
method.
The technical principle: Add the sample to the sample loading well
of test strip; the sample is mixed with the ALP-labeled
SARS-CoV-2 antigen, and flows through the filter film (filter red
blood cells) to the magnetic particle labeling area. Then the mixed
solution reconstitutes the magnetic particle-labeled SARS-CoV-2
antigen. If the sample contains SARS-CoV-2 antibody, a
"sandwich" structure complex of magnetic particle-labeled
antigen- SARS-CoV-2 antibody-ALP-labeled antigen is formed.
The complex is cleaned with a cleanser, and then the complex is
moved to the test area with a magnet to emit light in the
luminescent base fluid. A matching analyzer is used to obtain the
Relative Luminescent Unit (RLU) value, and the SARS-CoV-2
antibody concentration(AU/mL) in the sample is obtained
according to the standard curve of the reagent of this batch.
[Main Composition]
It consists of small package test strips: The specification of 10
servings/box contains 10 small packages, the specification of 20
servings/box contains 20 small packages, the specification of 25
servings/box contains 25 small packages, etc. Each small package
contains 1 test strip, of which the test strip is a microfluidic chip,
including ALP-labeled SARS-CoV-2 monoclonal antibody, coated
magnetic particles-labeled SARS-CoV-2 monoclonal antibody,
ALP luminescent solution, cleanser (pH7.4 Tris-HCl,
1/3
0.1% ProClin300), filter film, and chip substrate.
[Storage Conditions and Expiration Date]
The kit should be stored at 2 - 8 ℃, and valid for 6 months. Do not
freeze.
Each test strip is stored in a separate sealed bag. Use it within 2
hours after removing the sealed bag at room temperature
(18-30℃).
See the packaging label for the production date and expiration
date.
[Applicable Instruments]
MF02 series (MF02, MF02a, MF02b, MF02c, MF02 Pro), MF05
series (MF05, MF05a, MF05b, MF05c, MF05 Pro) and MF07
model semi-automatic chemiluminescence immunoassay analyzers
produced by Shenzhen Watmind Medical Technology Co., Ltd.
[Sample Requirements]
1. The recommended samples for this kit are serum,plasma and
whole blood. Serum and plasma collected by EDTA or heparin
anticoagulant blood collection tube, and whole blood collected by
EDTA-K2 and heparin sodium anticoagulant blood collection
tube.
2. The samples collected with the correct medical technology
should return to room temperature before testing. Jaundice,
hemolysis, lipemia, and cloudy samples cannot be used.
3. Serum, plasma and whole blood samples should be tested as
soon as possible. The samples should be tested within 8 hours at
room temperature (18-30℃). If the test cannot be completed, the
samples can be stored for 24 hours at low temperature of 2-8℃.
For long-term storage of serum and plasma samples, the
supernatant should be separated and repacked, and it can be stored
for 90 days below -20℃.
[Test Method]
Test Procedure
1. Preparation before test: The instrument is warmed up for at least
10 minutes.
2. Sample application: Click [Test] and select the sample type and
dilution factor.
3. Test: Add 20 uL sample to the test strip, cover the cap, and place
the test strip in the slot correctly. Click the screen again to enter
the Testing screen (start countdown).
4. Patient information input: In the Testing screen, click the edit
button in the lower right corner. Then you can enter patient
information.
5. Results display: After the test is completed, the instrument
automatically calculates the SARS-CoV-2 antibody concentration
value(AU/mL) of the current sample according to the standard
curve, and simultaneously displays the patient information. Then
you can print the test results directly. Click again to quickly return
to the main screen.
6. Quality control: Select the quality control test process to
determine the control and the results are automatically classified
into the quality control system of the instrument for judgment. The
control can be determined periodically according to the laboratory
requirements. The results obtained should be within the set limits.
If quality control is out of control, appropriate corrective actions
must be taken in accordance with laboratory rules and regulations.
For detailed instructions on quality control, refer to the Quality
Control Application and Quality Control Inquiry sections of the
IFU of the semi-automatic chemiluminescence immunoassay
analyzer.
Calculations
The system software uses a standard curve to automatically
determine the test results of a patient. The results are given in
AU/mL.
[Reference Interval]
Cut-off value: 1.0AU/mL
Note: Due to the complexity of clinical conditions, differences
between individuals and regional differences may affect the test
results; therefore, each laboratory is recommended to establish its
own reference interval based on the actual situation of its own
laboratory. The above data is for reference only.
[Interpretation of Test Results]
1. When the test result of the sample is <1.0 AU/mL, it means that
the test result of the sample is negative.
2. When the test result of the sample is ≥1.0 AU/mL, it means that
the test result of the sample is positive.
3. The test results of this kit are for clinical reference only, and
cannot be used as the sole basis for clinical diagnosis.
Comprehensive determination should be made in combination
with clinical symptoms and epidemiological history.
[Limitations of Test Method]
1. Due to limitations of methodologies or antibody specificity,
laboratory technicans should notice negative results and make
decision in combination with other testing result.It’s recommended
to retest debatable samples through virus isolation culture
identification.
2. During early infection, when IgM Ab isn’t formed or the
concertration is very low, it will cause a negative result. If there is
a suspected infection,it’s recomended to retest in 7-14 days to
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determine whether exist seroconversion in first infection or a
elevation in specific IgM and IgG antibody titre.
3. A high titre specific IgG Ab will fight with IgM Ab for antigen
binding site,which will decrease sensitivity of the test and cause
false negative result.
4. Patients with impared immunity or under immunosuppressive
therapy are not recommended to refer this interpretation of their
test results.
5. Patients with blood transfusion or under blood products
treatment in recent momths may have false positive results.
6. The hemolytic, lipemia, jaundice, and contaminated samples
may affect the test results. Such samples should be avoided.
7. If the sample contains interfering substances such as rheumatoid
factor,HAMA,etc, the test results will also be abnormal.
8. We do not test all types of collection tubes that may be used for
this kit; therefore, for blood sample collection tubes from different
manufacturers, different results may be obtained due to different
raw materials and additives.
[Product Performance Index]
1. Negative conformity rate: testing positive reference material of
the company ,there is no false negative result.
2. Positive conformity rate:. testing negative reference material of
the company ,there is no false positive result.
3. Repeatability: Coefficient of variation (CV) ≤ 10%.
[Precautions]
1. This product is only used for in vitro diagnosis, not for other
purposes; do not use expired reagents.
2. All reagent components, samples and various wastes should be
treated as infectious agents. At the same time, this product is a
one-time use product, and it should be destroyed centrally in
accordance with relevant laboratory requirements after use.
3. Please read the instructions carefully before operation, and
follow the instructions. During use, all laboratory reagent handling
precautions must be followed.
4. Wear appropriate gloves. If the test strip accidentally leaks, and
the skin accidentally comes into contact with the reagent, rinse
with plenty of water.
5. The test strip should be stored at 2 - 8 ℃, and should not be
stored frozen. Equilibrate to room temperature before use.
6. Due to methodologies or antibody specificity, different results
may be obtained on the same sample when different
manufacturers' reagents are used. The results obtained with
different reagents should not be directly compared with each other,
so as not to cause erroneous medical interpretation; the laboratory
is recommended to specify the characteristics of the reagents used
in the test report issued to the clinician.
[Explanation of Labels]

In Vitro Diagnostic (IVD) Device Refer to IFU

Non-Reusable Temperature Limit

[References]
1. Boscato Lm, et al. Heterophilic antibodies: a problem for all
immunoassays. Clin Chem, 1988, 34:27-33.
2. Kricka L. Interferences in immunoassays - still a threat. Clin
Chem, 2000, 46: 1037–1038.
3. Bjerner J, et al. Immunometric assay interference: incidence and
prevention. Clin Chem, 2002, 48: 613–621.
4.Feng Renfeng, The Quality Management Technique Bases in
Clinical laboratory, 2007, Apr
5.Peng Wenwei, Lemology (V5.0), PMPH,2001.

[Basic Information]
Registrant/Manufacturer Name: Shenzhen Watmind Medical Co.,
Ltd.
Address: 8th Floor, Building A, 16-1 Jinhui Road, Jinsha
Community, Kengzi Street, Pingshan District, Shenzhen, China
Phone: +86 755-86538356 Fax: +86 755-26658059
Postcode: 518055 Website: http://www.watmind.com/
Production address: 8th Floor, Building A, 16-1 Jinhui Road,
Jinsha Community, Kengzi Street, Pingshan District, Shenzhen,
China

[Medical Device Registration Certificate Number/Product

Technical Requirements Number]

[Date of Approval and Amendment of IFU]:2nd Mar, 2020

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