Sample Requirements
1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended solids in the sample may affect the
experimental results and should be removed by centrifugation.
3. Anticoagulant: heparin anticoagulant, EDTA anticoagulant and
sodium citrate anticoagulant have no obvious effect.
4. The blood collection work should be carried out by medical
professionals. It is recommended to give priority to serum/plasma
testing. In emergency or special circumstances, a patient's whole
blood sample can also be used for rapid testing.
5. Serum and plasma samples are stored at room temperature for more
than 8 hours. He/she/them
It can be stored for 5 days at 2-8°C, and for 6 months at below
20°C, but repeated freezing and thawing should be avoided. Whole
blood samples should not be frozen and should be stored at 2°C~8°C
for no more than 48 hours.
Test Method
Please read the instruction manual carefully before testing. Return
all reagents to room temperature before testing, and perform
testing at room temperature.
1. Take the test card out of the packaged reagent bag and use it
within one hour.
2. Add 20μL of sample (serum, plasma or whole blood) to the filling
hole of the test card, add 2 drops (~60μL), and start timing.
3. React for 10-15min at room temperature and read the result.
Invalid after 20 minutes.
Interpretation of Test Results
Test card explanation:
1. Invalid result: the non-response line on the quality control
line (line C) is invalid and should be tested again.
2. Negative results: the test line (T line) is displayed as a red
strip, the color is higher than or equal to the reference line (R
line), and the quality control line (C line) and the reference line
(R line) are colored.
3. Positive result: there is no red band on the test line (T line),
the color of the red band on the test line (T line) is smaller than
the reference line (R line), and the quality control line (C line)
and the reference line (R line) are colored.
Limitation of Test Method
1. This kit is used for qualitative testing and is only used for in
vitro auxiliary diagnosis.
2. Make sure to add the appropriate number of samples for testing.
Too much or too little sample size will lead to inaccurate results.
3. Hemolysis, lipids, jaundice and contaminated samples may affect
the test results and should be avoided.
4. The test results of this reagent are for clinical reference
only, and should not be used as the only basis for clinical
diagnosis and treatment. After a thorough evaluation of all
clinical and laboratory results, a final diagnosis should be made.
Product Performance Indicators
1. Analysis of specificity
1.1 1.1 Cross-reaction: The following types of antibody
interference reagents were evaluated, and the results showed that
there was no cross-reaction.
| SN | Item | Cross reaction | SN | Item | Cross reaction |
| 1 | Endemic human coronavirus OC43 | No | 10 | Enterovirus | No |
| 2 | Endemic human coronavirus HKUI | No | 11 | EB virus | No |
| 3 | Endemic human coronavirus NL63 | No | 12 | Measles virus | No |
| 4 | Endemic human coronavirus 229E | No | 13 | Human cytomegalovirus | No |
| 5 | Influenza A virus | No | 14 | Rotavirus | No |
| 6 | Influenza B virus | No | 15 | Norovirus | No |
| 7 | Respiratory syncytial virus | No | 16 | Mumps virus | No |
| 8 | Adenovirus | No | 17 | Varicella-zoster virus | No |
| 9 | Rhinovirus | No | 18 | Mycoplasma pneumoniae | No |
1.2 Interfering substances: Add the following substances to the
samples at specific concentrations to evaluate their potential
interference in 2019-nCoV and Ab test projects. The results showed
that all kinds of interfering substances did not interfere with the
test results of this reagent.
| Interfering substances | Concentration | Interfering substances | Concentration |
| Bilirubin | ≤50mg/dL | Triglycerides | ≤15mmol/mL |
| Hemoglobin | ≤5g/L | Cholesterol L | ≤500mg/d |
| Rheumatoid factor | ≤500IU/mL | Human total IgG | ≤14mg/mL |
| Ribavirin | 0.4mg/mL | Fluticasone | 0.5mg/mL |
| Oxymetazoline | 10mg/mL | Dexamethasone | 5 mg/mL |
| Histamine hydrochloride | 10mg/mL | Triamcinolone acetonide | 5mg /mL |
| Tobramycin | 1mg/mL | Levofloxacin | 0.2 mg/mL |
| Oseltamivir | 1mg/mL | Azithromycin | 0.1 mg/mL |
| Zanamivir | 1mg/mL | Ceftriaxone | 0.4 mg/mL |
| Arbidol | 0.5mg/mL | Meropenem | 0.2 mg/mL |
2. Clinical research: 120 positive samples and 300 negative samples
were selected for detection with the listed 2019-nCoVIgGAb
detection reagent (colloidal gold method) as the comparative
reagent. The research results are summarized as follows:
| 2019-nCoV IgG Ab detection reagent (colloidal goldmethod) |
Sum |
| Positive | Negative |
| Positive | 115 | 5 | 120 |
| Negtive | 5 | 295 | 300 |
| Sum | 120 | 300 | 420 |
| Sensitivity | 95.83%, (95%CI: 90.62%～98.21%) |
| Specificity | 98.33%, (95%CI: 96.16%～99.29%) |
Precautions
1. This product is only used for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Read the operating instructions carefully before operation, and
perform experimental operations in strict accordance with the
reagent instructions.
4. Avoid testing under harsh environmental conditions (including 84
kinds of disinfectants, sodium hypochlorite, acids, alkalis,
acetaldehyde and other high-concentration corrosive gases, dust,
etc.). After the experiment, laboratory disinfection should be
carried out.
5. All samples and reagents used should be considered as
potentially infectious materials and handled in accordance with
local regulations.
6. The reagent should be used within the validity period indicated
on the outer packaging. The test card should be used as soon as
possible after being taken out of the foil bag to prevent moisture.
Logo interpretation
| Do not re-use |
| Store at 2℃～30℃ |
| Consult instructions for use | 
| In vitro diagnostic medical device |
| Batch code | 
| Use-by date |
 | Keep dry | 
| Keep away from sunlight |
| Authorized representative in the European Community | 
| Manufacturer |
Basic Information
ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD
Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA
Tel:+86-371-55016575
Email:zosbio@zosbio.com
Web:www.zosbio.com
SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
Company profile
Zhongxiu Technology Co., Ltd. is a high-tech enterprise
specializing in the research and development, production and
operation of in vitro diagnostic products. The in vitro diagnostic
products developed by the company include POCT series, microbial
series, biochemical series, immune series reagents and supporting
instruments.
The company has always adhered to the core concept of "fast,
accurate, and life", committed to providing high-quality products
and services to the society, and contributing to the cause of human
health.
