For In Vitro Diagnostic and Professional Use Only Invalid:If no line appears in the Control area,the test results

Invalid:If no line appears in the Control area,the test results are Result s gave IgM&I gG sensit iv ity: 230/
* Please read the instructions before use carefully
invalid regardless of the presence or absence of line in the test 2 4 5 = 9 3 . 9 % (9 5% C l :9 0 .1 %~9 6.5% ), sp eci fic ity:3 57 /

Format: Cassette
COVID-19 IgM/IgG Ab Test area.The direction may not been followed correctly or the test
may be deteriorated.It is recommended that repeat the test using
36 4 =98 .1 % ( 95 % - C l : 9 6 . 1 % ~ 9 9 . 2 % ) , a n d
A c c u r a c y : 5 8 7 / 6 0 9 = 9 6 . 4 % (95%Cl:94.6%~97.7%).
Specimen: Serum/Plasma or Whole blood a new device.If the problem persist,please stop to use the
WARNING AND PRECAUTIONS product and contact local distributor. INDEX OF SYMBOLS
INTENDED USE 1. Read instruction for use carefully before performing this test.
COVID-19 IgM/IgG Ab Test is used for qualitative detection of the For in vitro diagnostic or refessional use only.
STORAGE AND STABILITY
2. Do not re-use Batch code
IgM and IgG antibodies of COVID-19 in human serum/plasma or 3. Do not use the test cassette beyond the expiration date. Storage: store at 2~30℃.
In vitro diagnostic
whole blood. The COVID-19 IgM/IgG Ab Test is an aid in the 4. The test cassette should remain in the sealed pouch until Shelf life: 12 months. medical device Use-by date
diagnosis of patients with suspected COVID-19 infection in use. Do not use the test cassette if the pouch is damaged or
conjunction with clinical presentation and the results of other
LIMITATION OF THE TEST Store between 2-30℃ Catalog number
the seal is broken.
laboratory tests. Results of the COVID-19 IgM/IgG Ab Test 5. Do not reuse the cassette. 1. This kit is a clinical auxiliary test product. Positive test results Manufacturer Consult instructions
for use
should not be used as the sole basis for diagnosis. 6. Treat and properly handle the specimens and used cassette need to be further confirmed (excluding false positives). Nega-
Normally, humans begin to produce antibodies about 1 week as if they were potentially infectious. Dispose all specimens tive test results cannot exclude the possibility of infection
after being infected with novel coronavirus, that is, the positive and used cassettes in a proper bio-hazard container. The (window period or false negative). MANUFACTURER CONTACT INFORMATION
rate of detection within 5 days after exposure to the source of handling and disposal of the hazardous materials should 2. When the SARS-CoV-2(COVID-19) antibody does not appear
infection is extremely low, the positive rate is about 80% at 2 follow local, national or regional regulations. at the time of sample collection or when the titer is lower than Core Technology Co.,Ltd.
weeks after infection and about 95% at 3 weeks, Antibody titers 7. Do not mix and interchange different specimens. the minimum detection limit of this kit, a negative result will Room 100, C Building, No.29 Life Park Rd.,
decreased significantly during the rehabilitation period, and there 8. Wear disposable gloves, lab coat and eye protection while appear, which should be combined with comprehensive analy- Changping District,Beijing, 102206 China
may be negative results. The false positive rate of uninfected handling potentially infectious material and performing the sis of clinical indicators and retested
,
within 5 to 10 days.
samples is about 2%. Most of the coloration belongs to the gray assay. Wash hands thoroughly afterwards. 3. IgM antibody positive doesn t only occurs in the primary
area, that is, the T line is not obvious purplish red color. Due to Clean spills thoroughly using an appropriate disinfectant. infection period, but also in the secondary infection. WellKang Ltd,
9.
the complex immune system and the continuous variation of viral 4. IgG antibody positive indicates infection or previous infection. 16 Castle St, Dover,kent, CT16 1PW, England,UK
genes, the test results are for reference only and are not used as SPECIMEN PREPARATION
the basis for diagnosis. PERFORMANCE CHARACTERISTICS
1. The specimen is human serum/plasma or whole blood,
including clinical anticoagulants (EDTA, heparin, sodium 1.Analytic Specificity
INTRODUCTION citrate) origin prepared serum or whole blood. Results demonstrated that Coretests ® COVID-19 IgM/IgG Ab
CoV is mainly transmitted through direct contact with secre- 2. Fingertip blood samples should be tested immediately, Test has no significant cross-reactivity with the seromarkers listed
tions or through aerosols and droplets. Evidence suggests serum, plasma, and anticoagulated whole blood are collect- following: Influenza A virus, Influenza B virus, Hepatitis B
transmission
,
via fecal-oral route.7 kinds of HCoVs caused ed, stored at room temperature for no more than 36 hours, at surface antibody, Hepatitis C virus, Parainfluenza virus, Human
human s respiratory diseases are found by now: HCoV-229E, 2 to 8℃ for no more than 3 months, serum plasma can immuno- deficiency virus, Adenovirus, Respiratory syncytial
HCoV-OC43,SARS-CoV,HCoV-NL63,HCoV-HKU1, MERS- be Doc No. IFU-COVID IgM/IgG/05-C
virus, EB virus, Mumps virus, Varicella zoster virus,
CoV stored at -20℃ for a long time, Deteriorated samples Enterovirus 71, Measles virus, Cytomegalovirus, Chlamydia Ver.1.2
,
and 2019-nCoV which are the serious pathogens for human s Eff.Date: Apr.2020
respiratory diseases. 2019-nCoV was found as the viral pneu- 3. may pneumoniae, Myco- plasma pneumoniae, Treponema pallidum.
affect the results. 2.Interference
monia in wuhan arise, Its clinical manifestatio n are fever, Bring the specimen and test components to room tempera- The following substances and conditions were found not to
enervat e and systemic symptom, with dry cough, difficult ture if refrigerated or frozen. Mix the specimen well prior to interfere with the test. List of potentially interfering compounds
breathing etc. and it may aggravate to severe pneumonia, assay once thawed.The precipitate should be removed by and concentrations tested are as follows:
respiratory failure, acute respiratory distress syndrome ,septic
shock, multiple organ failure , severe acid-base metabolic 4. centrifugation prior to the test if clearly visible particles Chemical analytes Concentrations Chemical analytes Concentrations
existed in the specimen.
disorders etc and even life threatening rapidly. Do not perform the test if specimen including massive lipid, Cholesterol 200mg/mL
Rheumatoid factor
80IU/mL
(RF)
PRINCIPLE TEST PROCEDURE Triglyceride 15mmol/L AMA 80U/mL
This test kit uses anti-human IgM, IgG antibodies and goat
anti-mouse IgG polyclonal antibodies that are respectively immo- Hemoglobin 9g/L HAMA 20ng/mL
bilized on a nitrocellulose membrane. It uses colloidal gold to buffer
Bilirubin 250μmol/L
label recombinant antigens of the SARS-CoV-2(COVID-19) and Serum/Plasma or Whole blood
mouse IgG. Using nano-colloidal gold technology and applying 10-15 minutes
3.Diagnostic sensitivity and specificity
highly specific antibody-antigen reaction and immunochromato- Results A clinical study using a total 609 blood samples was conducted.
graphic analysis technology principle. 1.Dispense 1 drop specimen to the 2.Add 2 drops of buffer to sample well The results of the COVID-19 IgM/IgG Ab Test were compared
When testing, the SARS-CoV-2(COVID-19) IgM antibody in the sample well
with clinical reference standard and refer to the results of nucleic
sample combined with the colloidal gold-labeled SARS-CoV-2 Read the instruction first prior to testing.Bring the pouched test acid detection test.The diagnostic sensitivity and specificity of the
(COVID-19) recombinant antigen to form a complex, which was to room temperature prior to testing.Do not open the pouch IgM and IgG test results are given as below:
then combined with the anti-human IgM monoclonal antibody until ready to begin testing. Table 1 - Comparison of COVID-19 Test-IgM
coated in the T1 line during chromatography, at this time there is 1. Remove the test from the sealed pouch.Lay it on a flat,clean Clinical reference
one red line in the T1. When the SARS-CoV-2(COVID-19) IgG and dry surface. standard Total Results
antibody in the sample combined with the colloidal gold-labeled 2. Use the pipette provided to add 1 dropčabout 10μLĎof Positive Negative
SARS-CoV-2(COVID-19) race antigen to form a complex, which specimen to the sample well. Results of Positive 219 6 225
is then combined with the anti-human IgG monoclonal antibody 3. Hold the buffer bottle vertically and add 2 drops of buffer Coretests
Negative 26 358 384
IgM test
coated in the T2 line during the chromatography process. At this (approximate 70μLĎto sample Total Results 245 364 609
time there is one red line in the T2. When the samples do not 4. well. Read results in10-15 minutes.
Results gave IgM sensitivity : 219/245=89.4%(95%Cl:84.8%~93%),
contain SARS-CoV-2(COVID-19) IgM and IgG antibodies, colloi-
INTERPRETATION OF RESULTS specificity :358/364=98.4%(95%Cl:96.5%~99.4%), and Accuracy:
dal gold-labeled SARS-CoV-2(COVID-19) recombinant antibod-
577/609=94.8%(95%Cl:92.7%~96.4%).
ies cannot combined with anti-human IgM and IgG antibodies in
Table 2 - Comparison of COVID-19 Test-IgG
the T1 and T2 line regions, so there is no red colored line in the
T1 and T2 lines .Regardless of the presence of SARS-CoV-2 Clinical reference
standard Total Results
(COVID-19) IgM and IgG antibodies in the sample, a red line will
Positive Negative
form in the control area (C). The red line appears in the control
Results of
area (C) serves as: 1.Verification that sufficient volume is added. Coretests
Positive 224 5 229

2.That proper flow is obtained 3. And as a control for the reagents. IgG test Negative 21 359 380
Total Results 245 364 609
MATERIALS PROVIDED IgG&IgM IgM IgG
NEGATIVE INVALID
Results gave IgG sensitivity: 224/229=91.4%(95%Cl:87.2%~94.6%),
POSITIVE POSITIVE POSITIVE
Coretests ® COVID-19 IgM/IgG Ab Test contains the following specificity :359/364=98.6 % (95%Cl:96.8%~99.6%) , and
items to perform the assay: IgG&IgM Positive:Control line and T1 line & T2 line appear in the Accuracy:583/609=95.7%(95%Cl:93.8%~97.2%).
test Window. Table 3 - Comparison of COVID-19 Test-IgM&IgG
1. COVID-19 IgM/IgG Ab Test Cassette
2. Instruction for use IgM Positive:Two colored lines appear,one is in T1 area and the Clinical reference
other line is in Control area. standard
3. Buffer 4. Pipette Total Results
IgG Positive:Two colored lines appear,one is in T2 area and the Positive Negative
MATERIALS REQUIRED BUT NOT PROVIDED other line is in Control area. Results of Positive 230 7 237
Coretests
1. Clock or Timer 2. Sample container Negative:Only one line appears in Control area,No line appears IgM/IgG test Negative 15 357 372
3. Glove 4. Sterile lancet in T1/T2 area. Total Results 245 364 609