SHENZHEN CORERAY TECHNOLOGY CO.

,LTD Tel:0086-755-28239229
E-mail:info@core-ray.com Web:www.core-ray.com
 Shenzhen Coreray Technology Co., Ltd.

New Coronavirus (COVID-19) IgM Ab Rapid Test

(Immunochromatographic Method)

Comparative Test Report

1. Method

In this trial, 140 clinical samples were selected. There were 40 positive samples and 100
negative samples.

The COVID-19 IgM Ab rapid test and the COVID-19 nucleic acid reagent were detected
simultaneously, and the positive coincidence rate, negative coincidence rate, and total
coincidence rate were calculated.

2. Result

（1）40 cases of positive samples confirmed by Nucleic Acid Test: tested with COVID-19 IgM
Ab rapid test, 30 cases were positive, 10 cases were negative.

（2）100 cases of negative samples confirmed by Nucleic Acid Test: tested with COVID-19
IgM Ab rapid test, 97 cases were negative, 3 cases were positive.

3. Analysis

（1）Results statistics table

COVID-19 Nucleic Acid Test

Total
IgM Ab Positive Negative
Rapid Test
Positive 30 3 33
Negative 10 97 107
Total 40 100 140

（2）Analysis of coincidence rate of COVID-19 IgM Ab rapid test and nucleic acid reagent in
serum samples

Positive coincidence rate=30/（30+10）×100%=75%

Negative coincidence rate=97/（3+97）×100%=97%

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 Shenzhen Coreray Technology Co., Ltd.

Total coincidence rate=（30+97）/（30+3+10+97）×100%=90.71%

4. Conclusion

COVID-19 IgM Ab rapid test and nucleic acid reagent positive coincidence rate of 75%,
negative coincidence rate of 97%, total coincidence rate of 90.71%

Shenzhen Coreray Technology Co., Ltd

27th FEB 2020

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 SARS-CoV-2 IgM/IgG Antibody Rapid Test pad solid phase mouse anti-human IgG monoclonal antibody, C-line coated 2. Add two (2) full drops of whole blood (20µl) vertically into the sample well of
(Immunochromatography) with goat anti-mouse IgG antibody. IgM and IgG separately.
Sample dilution: composed of 20 mM phosphate buffer solution (PBS) 3. Add two (2) drops (80-100µl) of sample buffer into the sample well of IgM
FOR PROFESSIONAL USE ONLY STORAGE AND EXPIRY and IgG separately.
PRODUCT NAME Store as packaged in the sealed pouch at 4-30℃, avoid hot and sunshine, dry 4. Observe the test results immediately within 15~20 minutes, the result is
SARS-CoV-2 IgM/IgG Antibody Rapid Test place, valid for 12 months. DO NOT FREEZE. Some protective measures should invalid over 20 minutes.
(Immunochromatography) be taken in hot summer and cold winter to avoid high temperature or freeze-
INTENDED USE thaw. Do not open the inner packaging until ready, it must be used in one hour
if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when
The kit is used to detect the IgM and IgG antibodies to severe acute respiratory
the humidity＞60%.
syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma or whole blood
sample qualitatively. It is to be used as an aid in the diagnosis of coronavirus SAMPLE REQUIREMENT
infection disease (COVID-19), which is caused by SARS-CoV-2 . 1. The reagent can be used for the serum, plasma and whole blood samples.
The test provides preliminary test results. Negative results don't preclude 2. A serum / plasma / whole blood sample must be collected in a clean and dry
SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or container. EDTA, sodium citrate, heparin can be used as anticoagulants in
other management decision. plasma / whole blood samples. Detect immediately after collecting blood.
TEST PRINCIPLE 3.Serum and plasma samples may be stored at 2-8℃ for 3 days prior to assay. If
This kit is an immunochromatographic assay, using capture method for rapid, testing is delayed more than 3 days, the sample should be frozen (-20℃ or INTERPRETATION OF RESULTS
qualitative detection of severe acute respiratory syndrome coronavirus 2 colder). Repeat freeze and thaw for no more than 3 times. Whole blood
POSITIVE: Two distinct red lines appear. One line should be in the control
(SARS-CoV-2) IgM/IgG antibody in human serum, plasma or whole blood samples with anticoagulant can be stored at 2-8℃ for 3 days, and should not
region (C) and the other line should be in the test region (T).
sample. be frozen; whole blood samples without anticoagulant should be used
NEGATIVE: One red line appears in the control region(C). No red or pink line
immediately (if the sample has agglutination, it can be detected by serum) .
SARS-COV-2 IgM appears in the test region (T).
TEST METHODS
When the sample contains the SARS-CoV-2 IgM antibody, it forms a complex INVALID: No red lines appear or control line fails to appear, indicating that the
with the gold label antigen (SARS-CoV-2 recombinant antigen). The complex Instructions must be read entirely before taking the test. Allow the test device
operator error or reagent failure. Verify the test procedure and repeat the test
moves forward under the action of chromatography and combines with the controls to equilibrate to room temperature for 30 minutes (20℃-30℃) prior
with a new testing device.
coated antibody (Mouse anti-human IgM monoclonal antibody) at the T line to to testing. Do not open the inner packaging until ready, it must be used in one
form a complex and develop color (T line), which is a positive result. When the hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately
sample does not contain the SARS-CoV-2 IgM antibody, no complex can be when the humidity＞60%.
C C C
formed at the T line, and no red band appears, which is a negative result. For Serum/Plasma
Regardless of whether the SARS-CoV-2 IgM antibody is contained in the sample, 1. Remove the test device from the sealed pouch, place it on a clean and level
T T T
the gold label quality control antibody (rabbit IgG antibody) will bind with the surface with the sample well up.
Positive Negative Invalid
coated antibody (goat anti-rabbit IgG antibody) at the C line to form a complex 2. Add one (1) full drop of serum or plasma (10µl) vertically into the sample
and develop color (C line). well of IgM and IgG separately. LIMITATIONS
SARS-COV-2 IgG 3. Add two (2) drops (80-100µl) of sample buffer into the sample well of IgM 1. This reagent is designed for the qualitative screening test. Concentration of
When the sample contains the SARS-CoV-2 IgG antibody, it forms a complex and IgG separately. SARS-CoV-2 IgM/IgG antibody cannot be determined by this qualitative test.
with the gold label antibody (Mouse anti-human IgG monoclonal antibody). 4. Observe the test results immediately within 15~20 minutes, the result is The depth of the T-line color is not necessarily related to the concentration of
The complex moves forward under the action of chromatography and combines invalid over 20 minutes. the antibody in the sample.
with the coated antigen (SARS-CoV-2 recombinant antigen) at the T line to form 2. The results of the reagent are only for clinical reference, which is not the only
a complex and develop color (T line), which is a positive result. When the basis for clinical diagnosis and treatment. A confirmed diagnosis and treatment
sample does not contain the SARS-CoV-2 IgG antibody, no complex can be should only be made by a physician after all clinical and laboratory findings
formed at the T line, and no red band appears, which is a negative result. have been evaluated.
Regardless of whether the SARS-CoV-2 IgG antibody is contained in the sample, PERFORMANCE CHARACTERISTICS
the gold label quality control antibody (Mouse anti-human IgG monoclonal 1. Sensitivity and Specificity
antibody) will bind with the coated antibody (goat anti-mouse IgG antibody) at
SARS-CoV-2 IgM
the C line to form a complex and develop color (C line).
SARS-CoV-2 IgM Ab PCR Test Total
MAIN COMPONENTS
SARS-CoV-2 IgM: T-line coated with mouse anti-human IgM monoclonal Positive Negative
Rapid Test
antibody, gold label pad solid phase SARS-CoV-2 recombinant antigen, rabbit For Whole Blood Positive 246 40 286
IgG antibody, C-line coated with goat anti-rabbit IgG antibody. 1. Remove the test cassette from the sealed pouch, place it on a clean and level Negative 54 960 1014
SARS-CoV-2 IgG: T-line coated with SARS-CoV-2 recombinant antigen, gold label surface with the sample well up.

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 Total 300 1000 1300 BIBLIOGRAPHY
[1] Nanshan Chen, Min Zhou, Xuan Dong, et al. (2020). Epidemiological and
Analysis of coincidence rate of SARS-CoV-2 IgM Ab rapid test and PCR Test in
clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in
serum samples:
Wuhan, China: a descriptive study. The Lancet, 395(10223), 507-513.
Positive coincidence rate=246 / (246+54) × 100% = 82%,
[2] Chaolin Huang, Yeming, et al. (2020). Clinical features of patients infected
Negative coincidence rate=960 / (40+960) × 100% = 96%, with 2019 novel coronavirus in Wuhan, China. The Lancet, 395(10223),
Total coincidence rate=(246+960) / (246+54+40+960) × 100% = 92.8%. 497-506.
SARS-CoV-2 IgG [3] Chen Wang, Peter W Horby, Frederick G Hayden, George F Gao. (2020). A
SARS-CoV-2 IgG Ab PCR Test Total novel coronavirus outbreak of global health concern. The Lancet, 395(10223),
Positive Negative 470-473.
Rapid Test
[4] Na Zhu, Ph.D., Dingyu Zhang, M.D., Wenling Wang, Ph.D., et al. (2020). A
Positive 279 25 304
Novel Coronavirus from Patients with Pneumonia in China, 2019. The New
Negative 21 975 996 England Journal of Medicine.
Total 300 1000 1300 [5] World Health Organization: Clinical management of severe acute respiratory
infection when Novel coronavirus (nCoV) infection is suspected: Interim
Analysis of coincidence rate of SARS-CoV-2 IgG Ab rapid test and PCR Test in Guidance. 12 January, 2020.
serum samples:
Positive coincidence rate=279 / (279+21) × 100% = 93%, 2020-03
Negative coincidence rate=975 / (25+975) × 100% = 97.5%, 2020.03.10
Total coincidence rate=(279+975) / (279+21+25+975) × 100% = 96.5%.
2. Cross-reactivity
Specimens which tested positive with following various agents from patients
were investigated with SARS-CoV-2 IgM/IgG Ab Rapid Test. The results showed
no cross reactivity.
SARS-CoV-2 IgM SARS-CoV-2 IgG
Mycoplasma pneumoniae IgM Ab Mycoplasma pneumoniae IgG Ab
Influenza A IgM Ab Parainfluenza IgG Ab
Influenza B IgM Ab Respiratory Syncytial virus IgG Ab
Parainfluenza IgM Ab Adenovirus IgG Ab
Respiratory Syncytial virus IgM Ab Chlamydia pneumoniae IgG Ab
Adenovirus IgM Ab -
Chlamydia pneumoniae IgM Ab -
3. Interferences
The test result of SARS-CoV-2 IgM/IgG Ab Rapid Test do not be interfered with
the substance at the following concentration:
Substance Concentration
Hemoglobin ≤ 10g/L
Triglyceride ≤ 6mmol/L
Bilirubin ≤ 1000μmol/L
No interference from rheumatoid factors, antinuclear antibodies and
antimitochondrial antibodies.
ATTENTIONS
1. For IN VITRO diagnostic use only.
2. Reagents should be used as soon as possible after opened. This reagent
cannot be reused for disposable.
3. The test device should remain in the sealed pouches until use. If sealing
problem happens, do not test. Don’t use after the expiration date.
4.All specimens and reagents should be considered potentially hazardous and
handled in the same manner as an infectious agent after use.

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 MATERIAL SAFETY DATA SHEET

The goods is classified as NOT RESTRICTED as per IATA Dangerous Goods Regulations
60th Edition.（2020）
Effective 31th December, 2020

Section 1: Chemical And Company Identification

Name: IVD DIAGNOSTIC REAGENT

Structure:
Manufacturer: SHENZHEN CORERAY TECHNOLOGY CO.,LTD
Address: Liangji Building, fukang Area,
- 1st Dong huan road, Longhua district, Shenzhen, China, 518109.
Phone: (0086) 0755-28239229
Fax: (0086) 0755-28239229

Section 2: Desctibe types of medial equiment

1. The human chorionic gonadotrophin rapid test kit is a rapid chromatographic immunoassay for the qualitative detection of
human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
2. The testing kit is in the form of strip, cassette, and midstream. Basic components: Sample pad, colloidal gold marked pad,
nitrocellulose membrane, absorbent paper and PVC board. Colloidal gold marked pad coated with HCG-α monoclonal
antibody, nitrocellulose membrane coated with HCG-β monoclonal antibody，control line coated with goat anti-rat IgG.
3. The reagent is used to detect the HCG in urine qualitatively according to the principle of double antibody sandwich
method.
4. Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate to room temperature
for 30 minutes (20℃-30℃) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if
opened (Humidity: 20%~90%, Temp: 10℃-50℃)
Strip:
1.Remove the test device from the sealed pouch, put the end of the test strip print with arrow into the urine, the interface of
urine should not exceed the max line（180 ~200μL）, take it out and place the test device on a clean and level surface after
5 to 8 seconds.
2. Observe the test results immediately within 5 minutes, the result is invalid over 5 minutes.

Section 3: Hazards Identification

Hazards identification not classified as dangerous according to EC directives.

Section 4: First-Aid Measures

Skin Contact:Remove from source of exposure.Wash affected area with soap and water.If irritation or signs of toxicity
occur,seek medical attention.
Eye Contact:Remove from source of exposure.Wash with copious amounts of water for at least 15 minutes.If irritation
or signs of toxicity occur,seek medical attention.
Ingestion:If irritation or signs of toxicity occur,seek medical attention.
The following symptoms may occur:Irreversible eye damage.
Medical conditions aggravated by exposure:Pre-existing eye ailments.Hypersensitivity.
This material should be considered as being potentially infectious.

Section 5: Fire Fighting Measures

Extinguishing Media:Suitable extinguishing agents including CO2, WATER SPRAY or Regular foam

Section 6: Accidental Release Measures

Accidental release measures Wear appropriate protective clothing. Carefully sweep up. Transfer to suitable containers
for recovery or disposal.

Section 7: Handling And Storage

Wash hands and face thoroughly after working with material. Contaminated clothing should be removed and washed
before re-use. Keep well closed and protected from direct sunlight and moisture.

Section 8: Exposure Controls/Personal Protection

Ventilation: No specific measures necessary.
Gloves: Rubber or plastic
Eye Protection: Goggles or face-shield

Section 9: Physical And Chemical Propertie

Appearance And Odor: Uncut sheets to produce packaged kit with bottled assay diluent and test cassettes and Odorless.
Physical Properties:
phase transitions: no data
melting point: no data
flashpoint no data

Section 10: Stability And Reactivity

Chemical stability: Stable at normal temperature and pressure.
Incompatibility with other substances: not available
Hazardous decomposition products: oxides of carbon.

Section 11: Toxicological Information

Acute effects: not data available
Inhales: not data available.
Contact with skin: not data available.
Ingestion: no data available.

Section 12: Ecological Information

Ecotoxicity: not available.
Environmental fate: not available.

Section 13: Disposal Considerations

Chemical residues are generally classified as special waste, and as such are covered by regulations which vary according to
location. Contact your local waste disposal authority for advice, or pass to a chemical disposal company. Rinse out containers
before disposal.
 Section 14: Transport Information

We hereby certify that the above captioned goods are “NOT RESTICTED” for air transportation in any nature.
The goods are correctly described by the shipment name and packed in a clean, good and strong outer packaging forcarriage by
air. The goods is classified as NOT RESTRICTED as per IATA DGR 60th Edition. (2019)
Contact Qingdao Hightop Biotech Co., Ltd. For Transportation Information.

Section 15: Regulatory Information

China regulatory information
The Inventory of Existing Chemical Substances in China (IECSC) is listed.

Section 16: Other Information

DATE ISSUED: 2020-01-31
PREPARED BY: SHENZHEN CORERAY TECHNOLOGY CO.,LTD

The information contained herein based on the present state of our knowledge. It characterizes the
product with regard to the appropriate safety precautions. Valiant shall not be held liable for any damage
resulting from handling or from contact with the above product.
 EC Declaration of Conformity
in accordance with Directive 98/79/EC

Manufacturer:

Name: Shenzhen Coreray Technology Co., Ltd.

Address: 305 307, Liangji Building, fukang Area, 1st Dong huan road,
Longhua district, Shenzhen, China, 518109.

Product/s Catalogue number

2019-nCOV IgG/IgM Rapid Test Device K460216D

Category: Other Devices (All devices except Annex II and self-testing devices)

Conformity assessment route: Annex III,except Point 6,of Directive

Applicαble Stαndαrds:EN ISO 13485:2016;EN ISO 15223-1:2016;

EN ISO 14971:2012 ;EN ISO 13612:2002;EN ISO 17511:2003;
EN ISO 18113-1:2011;EN ISO 18113-2:2011,EN ISO 18113-3:2011;
EN ISO 23640:2015;EN 62366:2008.

We, the Manufacturer, herewith declare with sole responsibility that our product/s
mentioned above meet/s the provisions of the Directive 98/79/EC of the European
Parliament and of the Council on In-Vitro Diagnostic Medical Devices.

We hereby explicitly appoint Wellkang Ltd,located at The Black church,

St. Mary’s Place, Dublin 7, Irelandto act as our European Authorised
Representative as defined in the aforementioned Directive.

(Place and date of issue) (Signature and position)

Signed for and on behalf of the manufacturer