Product Name IgG antibodies are present in specimen, the antibodies will bind to

colloidal gold-labeled 2019-nCoV antigens to form compounds, and

2019-nCoV Ab Test (Colloidal Gold)
further form new compounds by binding to pre-coated mouse-anti
Intended Use human monoclonal IgG antibodies, which give rise to purple line (T).
The kit is intended for the qualitative detection of IgM and IgG The binding of colloidal gold-labeled mouse IgG antibodies with
antibodies against 2019 Novel Coronavirus (2019-nCoV) in human goat-anti-mouse IgG antibodies will present purple line, which is used
serum/plasma/venous whole blood specimen. It is only used as a as the control line(C).
supplementary detection indicator for suspected nucleic acid negative Composition
results or in conjunction with nucleic acid detection in the diagnosis of 1. Sealed foil pouches each containing:
suspected cases. It cannot be used as a basis for the diagnosis and a. One cassette device
exclusion of COVID-19. It is not suitable for general screening. b. One desiccant
A positive test result requires further confirmation. A negative test 2. Specimen diluent
result does not rule out the possibility of infection. 3. Instructions for use
This product is limited to clinical use and emergency reserve during Storage and Stability
the COVID-19 epidemic outbreak since December 2019, and cannot 1. Store at 4℃~ 30℃（39.2℉~ 86℉）.

Instructions for be used in the clinic as a conventional in vitro diagnostic reagent. The
test results of this kit are for clinical reference only. It is recommended
to conduct a comprehensive analysis of the condition based on the
2. Use the test within 1 hour after opening the pouch under 60%
humidity.
3. See production date and expiration date on label.

2019-nCoV Ab Test
patient's clinical manifestations and other laboratory tests. Specimen Collection and Handling
Laboratory testing of 2019-nCoV should meet the requirements of the
"Technical Guidelines for Laboratory Testing of COVID-19 Infection" to Consider any materials of human origin as infectious and
do a better biosafety job. handle them using standard bio-safety procedures.

(Colloidal Gold) Summary

1. The kit is intended for test only in serum/plasma/venous whole
blood specimens.
Coronaviruses (CoV) are a large family of viruses that cause illness 2. Specimens should be collected by standard protocol.
ranging from the common cold to more severe diseases such as 3. The venous whole blood specimens could be stored at 2℃~ 8℃
Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute
Respiratory Syndrome (SARS-CoV). 2019-nCoV is a new strain that (36℉~46℉) for up to 3 days, and it couldn’t be frozen. Venous
has not been previously identified in humans. whole blood specimens can be anti-coagulated with routine
Common signs of infection include respiratory symptoms, fever, cough, dosage of heparin (9.8-28IU/mL), sodium citrate (3.8%, equivalent
shortness of breath and breathing difficulties. In more severe cases, to 129mmol/L), ethylenediaminetetraacetic acid (EDTA)
infection can cause pneumonia, severe acute respiratory syndrome, (4.55mmoL / mL ± 0.85 mmol/mL).
kidney failure and even death. 4. The serum or plasma specimen s could be stored at 2℃~ 8℃
Standard recommendations to prevent infection spread include
regular hand washing, covering mouth and nose when coughing and (36℉~46℉) for up to 7 days, and could be frozen at -20℃（-4℉）
sneezing, thoroughly cooking meat and eggs. Avoid close contact with for 6 months. The specimens are repeatedly frozen and thawed no
anyone showing symptoms of respiratory illness such as coughing more than 8 times; it should be the best to test the sample after
and sneezing. collection immediately.
Current estimates of the incubation period range from 1-12.5 days 5. Prior to testing, bring frozen specimens to room temperature
with median estimates of 5-6 days. These estimates will be refined as slowly and mix gently. Specimens containing visible particulate
more data becomes available. Based on information from other matter should be clarified by centrifugation before testing.
coronavirus diseases, such as MERS and SARS, the incubation Test Procedure
period of 2019-nCoV could be up to 14 days. WHO recommends that
the follow-up of contacts of confirmed cases is 14 days. 1. Allow the test, specimen diluent and/or controls to reach room
temperature 10℃~30℃ (50℉~86℉) prior to testing.
Principle
2. Remove the test device from the sealed pouch and use it as
The kit detects 2019-nCoV IgM and IgG antibodies by
soon as possible.
immuno-capture method. The nitrocellulose membrane is coated by
3. Place the test device on a clean and level surface.
mouse-anti human monoclonal IgM antibodies, mouse-anti human
4. FROM THE TOP OF THE SPECIMEN WELL: Add 20µL
monoclonal IgG antibodies, and goat-anti-mouse IgG antibodies. The
venous whole blood or 10µL serum/plasma specimen into each
recombinant 2019-nCoV antigen and mouse IgG antibodies are
specimen well.
INNOVITA (Tangshan) Biological Technology Co., Ltd. labeled with colloidal gold as a tracer. After addition of the specimens,
5. FROM THE BOTTOM OF THE SPECIMEN WELL: Add 80µL or 2
if 2019-nCoV IgM antibodies are present, the antibodies will bind to
drops of specimen diluent into each specimen well.
colloidal gold-coated 2019-nCoV antigens to form compounds, which
6. Wait for the colored line(s) to appear. Read results within 15
are further captured by pre-coated mouse-anti human IgM antibodies
minutes. Do not read the result after 15 minutes.
to form new compounds, and generate purple line (T). If 2019-nCoV
 5. The 2019-nCoV IgM test was also evaluated with samples that are Limitations
IgM positive for other diseases as listed in the following table. No 1. The kit is for qualitative detection and auxiliary diagnosis use only.
2019-nCov 2019-nCov
IgM lG IgM lgG cross reactivity was observed. 2. In the early phase of infection, no IgM or IgG antibody will be
Coronavirus HKU1-IgM Coronavirus OC43-IgM produced, or the titer will be very low, thus, negative result will
Coronavirus NL63-IgM Coronavirus 229E-IgM occur. Re-testing will be conducted in 7-14 days, and the sample
Results Influenza A virus H1N1 (new type that is collected last time will be detected in parallel during
influenza A virus H1N1 2009, seasonal H3N2-IgM re-testing to confirm whether the serology turns positive or the
influenza virus H1N1) IgM
titer increases significantly.
H5N1-IgM H7N9-IgM
Influenza B virus IgM Respiratory Syncytial Virus IgM 3. The reference value of serological antibody detection is limited for
Add 20 μL venous whole Add 80μL(or 2 drops) the immune-compromised patients or patients who receive
Adenovirus IgM Rhinovirus IgM
blood or 10μL serum/plasma of specimen diluent immunosuppressive therapy.
Enterovirus A-IgM EB virus IgM
Results Interpretation Measles virus IgM Cytomegalovirus IgM 4. IgM antibody positive will occur not only in primary infection, but
1. IgM Positive: The presence of two purple bands (T and C) within Rotavirus IgM Mumps IgM also in secondary infection.
the IgM result window indicates positive for 2019-nCoV IgM Varicella-zoster virus IgM Parainfluenza virus IgM 5. IgG antibody positive indicates previous infection or secondary
antibody. Mycoplasma pneumoniae IgM Chlamydia pneumoniae IgM infection.
2. IgG Positive: The presence of two purple bands (T and C) within Coxsackievirus group B IgM 6. The confirmation or exclusion of infection will be combined with
the IgG result window indicates positive for 2019-nCoV IgG 6. The 2019-nCoV IgG test was also evaluated with samples that the patient’s clinical manifestations or other further methods.
antibody. are IgG positive for other diseases as listed in the following table.
Precaution
3. Negative: Only one purple band appearing at the control line (C) No cross reactivity was observed.
indicates negative result. Coronavirus HKU1-IgG Coronavirus OC43-IgG 1. Use fresh specimens whenever possible.
4. Invalid: If control line (C) fails to appear, no matter whether the T Coronavirus NL63-IgG Coronavirus 229E-IgG 2. Results after 15 minutes are considered invalid.
line is visible or not, the test is invalid. Insufficient specimen
IInfluenza A virus H1N1 (new type influenza 3. The product should be used as soon as possible once the foil
A virus H1N1 2009, seasonal influenza H3N2-IgG pouch is open, in case of long-term exposure to environment.
volume or incorrect procedural techniques are the most likely virus H1N1) IgG
reasons for control line failure. Review the procedure and repeat 4. Follow standard biosafety guidelines for handling and disposal of
H5N1-IgG H7N9-IgG
the test with a new test device. If the problem persists, you should potential infective material.
Influenza B virus IgG Respiratory Syncytial Virus IgG
immediately stop using the kit with the same LOT No. and contact Adenovirus IgG Rhinovirus IgG
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD.
your local distributor. Enterovirus A-IgG EB virus IgG
No. 699 Juxin Street, High-tech Industrial Development Zone,
Measles virus IgG Cytomegalovirus IgG Qian'an, Hebei, 064400, China.
Rotavirus IgG Mumps IgG
Varicella-zoster virus IgG Parainfluenza virus IgG SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands.
Mycoplasma pneumoniae IgG Chlamydia pneumoniae IgG
TEL: +31（0）2021 11106
Coxsackievirus group B IgG
7. RF, ANA and AMA don’t exhibit cross reactivity with the test.
8. Common antivirals such like Epistine hydrochloride (≤4mg/L), Do not reuse For in vitro diagnostic use only
Ribavirin (≤40mg/L), Interferon (≤200mg/L), Oseltamivir (≤30mg/L),
Performance Characteristics Abidol (≤40mg/L), Levofloxacin (≤200mg/L), Azithromycin Stored between
Consult instruction for use
1. Use the national or enterprise reference controls for testing, and (≤100mg/L), Ceftriaxone (≤400mg/L), Meropenem (≤200mg/L) have 4-30℃
the results meet the detection requirements of national or no interference effect on the detection of this kit. Caution Lot number
enterprise reference controls. 9. Systemic lupus erythematosus has no interference effect on the Contains sufficient for <n>
2. Test the samples with a titer of 1:320 at the original detection of this kit. Use by
tests
concentrations with the 2019-nCoV IgM antibody and 2019-nCoV 10. Non-specific IgM antibody (≤0.8mg/mL) and non-specific IgG Keep away from
IgG antibody. No hook effect was observed. antibody (≤4mg/mL) have no interference effect on the detection Keep dry
sunlight
3. The clinical trial of this product is based on the clear diagnosis / of this kit. Do not use if package is
exclusion criteria of the disease identified in the “COVID-19 11. Heparin, sodium citrate, EDTA and other anticoagulants have no Manufacturer
damaged
Diagnosis and Treatment Program". Clinical research was interference effect on the detection of this kit.
12. The precision experiments were carried out by different Authorized Representative in the European Community
conducted in 5 institutions and the total cases were 447. Using
this kit, 110 cases out of 126 clinically confirmed cases are experimenters, at different times and at different places, and the CE Mark
positive, with the sensitivity of 87.3% (95% CI: 80.40% to 92.0%); results met the product performance requirements.
62 cases of clinically excluded cases are totally negative with the 13. After the specific IgM positive sample was destroyed by
No.: Q/JSRDY373-1.0-05
specificity of 100% (95% CI: 94.20% to 100%). β-mercaptoethanol, the IgM test result was negative.
Effective Date:Mar. 8, 2020
4. Avoid using special samples: red background may appear in the 14. After preliminary evaluation, it is basically confirmed that the
hyperlipemia (triglyceride concentration higher than 25mg/ml), clinical performance of the product can meet the emergency
icteric samples (Bilirubin concentration higher than 0.2mg/mL) needs of the epidemic. The product will further collect clinical data
and hemolytic specimen (hemoglobin concentration more than to confirm the clinical performance of the product after it is
5.0mg/mL). which may affect the test result. marketed.