Keep at 2 ° C to 30 ° C and the effective period is 12 months.
The aluminum foil bag is valid for 1 hour.
Lot No .: See label for details.
Validity period: See label.
Sample Requirements
1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in the sample may affect the
experimental results and should be removed by centrifugation.
3. Anticoagulant: Heparin, EDTA, sodium citrate are ineffective.
4. Venipuncture is performed by a professional medical staff. We
recommend that you give priority to serum / plasma tests. In
emergencies and special cases, a patient's entire blood sample can
also be used for rapid testing.
5. The storage time of serum and plasma samples at room temperature
should not exceed 8 hours. They are
It can be stored at 2 ° C to 8 ° C for 5 days and below -20 ° C for
6 months, but avoid repeated freeze-thaw cycles. Whole blood
samples should not be stored frozen at 2 ° C-8 ° C within 48 hours.
Test Method
Please read the instructions carefully before testing. Allow all
reagents to cool to room temperature before testing. The test is
conducted at room temperature.
1. Remove the test card from the packaged reagent bag and use it
within 1 hour.
2. Add 20 μL of sample (whole serum and plasma), add 2 drops of
sample buffer (about 60 μL), and start the clock.
3. After reacting at room temperature for 10 to 15 minutes, read
the results. After 20 minutes, the result was invalid.
Interpretation of Test Results
Figure to judge the result of the test card:
1. Invalid result: Quality control line (c line) has no reaction
line, is invalid and needs to be retested.
2. Negative result: A red band appears on the test line (T line)
and the color is higher than or equal to the reference line (R
line), and the color is on the quality control line (C line) and
the reference line (R line). arrive.
3. Positive result: The test line (T line) has no red band and is
smaller than the reference line (R line), and the control line (C
line) and reference line (R line) are colored.
Limitation of Test Method
1. This kit is used for qualitative tests and is used only for
in-vitro assisted diagnosis.
2. Make sure to add the appropriate amount of sample and perform
the test. If the sample size is too large or too small, the results
may be incorrect.
3. Hemolysis, blood fats, jaundice, and contaminated samples should
be avoided as they can affect test results.
4. The test results of this reagent are for clinical reference only
and cannot be the sole basis for clinical diagnosis and treatment.
The final diagnosis should be a combination of evaluation and
laboratory results from all clinical trials.
Product Performance Indicators
1. Analysis of specificity
1.1 1.1 Cross-reactivity: As a result of evaluating the following
types of antibody interfering reagents, there was no
cross-reactivity.
| 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 are added to
the sample at specific concentrations to assess potential
interference in the 2019 nCoV and Ab test items. As a result, none
of the interfering substances interfered with the detection 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: Using the above 2019 NCOVIGAB detection reagent
(colloidal gold method) as a comparative reagent, 120 positive
samples and 300 negative samples are selected and tested. The
research results can be 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 used only for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Read the instructions carefully before starting work and perform
the experimental work according to the reagent instructions.
4. Avoid inspections under harsh environmental conditions
(including 84 disinfectants, sodium hypochlorite, alkali or
acetaldehyde, high concentration corrosive gases such as dust).
After the experiment is over, disinfect the laboratory.
5. All samples and reagents used are considered potential
contagious substances and should be disposed of in accordance with
local laws and regulations.
6. Reagents should be used within the shelf life indicated on the
package. Use a test card as soon as you remove it from the aluminum
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 Science And Technology Co.,Ltd., is a high-tech enterprise
engaged in the research and development, production and operation
of in vitro diagnostic products. The in vitro diagnostic products
developed by the company cover POCT series, microbial series,
biochemical series and immune series reagents and supporting
instruments.
The company has always adhered to the core concept of "fast and
accurate, living up to life", committed to providing society with
excellent products and services, and contributing to the cause of
human health.
