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. Anticoagulation: heparin anticoagulation, EDTA anticoagulation and sodium citrate anticoagulation have no obvious effect.
4. Blood collection shall be carried out by medical personnel. It is recommended to give priority to serum / plasma testing. In emergency or special cases, the patient's whole blood sample can also be used for rapid detection.
5. Serum and plasma samples were stored at room temperature for more than 8 hours. He / she / they
It can be stored at 2-8 ℃ for 5 days and below 20 ℃ for 6 months, but repeated freezing and thawing should be avoided. Whole blood samples should not be frozen and should be stored at 2 ℃ to 8 ℃ for no more than 48 hours.
Test Method
Please read the instructions carefully before testing. Return all reagents to room temperature before testing and test at room temperature.
1. Take out the test card from the packaged reagent bag and use it within one hour.
2. Replace 20 μ L sample (serum, plasma or whole blood) is added into the filling hole of the detection card, and 2 drops (~ 60 ml) are added μ 50) , start timing.
3. React at room temperature for 10-15 minutes and read the results. Invalid after 20 minutes.
Interpretation of Test Results
Test card Description:
1. Invalid result: the non response line (line C) on the quality control line is invalid and should be retested.
2. Negative result: the test line (t line) is displayed as a red bar, the color is higher than or equal to the reference line (r line), and the quality control line (C line) and reference line (r line) are colored.
3. Positive results: there is no red band on the test line (t line), the color of the red band on the test line (t line) is less than the reference line (r line), and the quality control line (C line) and reference line (r line) are color.
Limitation of Test Method
1. This kit is used for qualitative detection and only for in vitro auxiliary diagnosis.
2. Ensure that an appropriate number of samples are added for testing. Too much or too little sample size will lead to inaccurate results.
3. Hemolysis, lipid, jaundice and contaminated samples may affect the test results and should be avoided.
4. The test results of this reagent are only for clinical reference and should not be used as the only basis for clinical diagnosis and treatment. The final diagnosis shall be made after a thorough evaluation of all clinical and laboratory results.
Product Performance Indicators
1. Specificity analysis
1.1.1 Cross-reaction: The following types of antibody interfering reagents were evaluated and no cross-reaction was found.
| 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: The following substances were added to the sample at specific concentrations to assess their potential interference in the 2019 nCoV and Ab test items. The results showed that all kinds of interfering substances did not interfere the detection results of the 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 study: 120 positive specimens and 300 negative specimens were selected for detection with the listed 2019 NCOVIGAB detection reagent (colloidal gold method) as the control reagent. The 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 disposable and cannot be recycled.
3. Read the operating instructions carefully before operation and carry out the experimental operation in strict accordance with the reagent instructions.
4. Avoid testing under harsh environmental conditions (including 84 disinfectants, sodium hypochlorite, acid, alkali, acetaldehyde and other high concentration corrosive gases, dust, etc.) After the experiment, the laboratory should be disinfected.
5. All samples and reagents used should be considered as potentially infectious substances and treated in accordance with local regulations.
6. The reagent shall be used within the validity period indicated on the outer package. The test card shall 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 development, production and management of in vitro diagnostic products. In vitro diagnostic products developed by the company include POCT series, microbial series, biochemical series, immune series reagents and supporting instruments.
The company always adhere to the core concept of "fast, accurate, life", is committed to providing quality products and services for the society, to make contributions to human health.
