Sample Requirements
- Water, serum, plasma, or a whole blood sample will be collected.
- The sludge and suspended solids in the sample can affect the
results obtained from the experiment and should be removed by
centrifugal force.
- Effects of Heparin, EDTA and Sodium Citrate
- The water will be collected by professional medical personnel. It
pointed out that the detection of plasma levels should be a special
consideration. In an emergency or special situation, a patient's
entire blood sample can also be used for a quick examination.
- Serum and plasma samples should not be stored at room temperature
for more than eight hours, but you should keep them for the next
five days. All blood samples must not exceed 48 hours cryogenic
freezing.
Test Method
Read the instructions carefully before testing. Please recall all
chemicals at room temperature before testing and test at room
temperature.
- Take the test card from the bag packaging and use it within an
hour.
- The whole serum or plasma or whole blood sample is dripped into the
hole of the test card and then dripped to approximately 60μL sample
buffer start time.
- weight at room temperature and read the result Read the result
incorrectly after twenty minutes.
Interpretation of Test Results
Figure for judging test card results:
1. Incorrect result, no reaction on line C, test is invalid and
should be repeated.
2. Negative result, line T shows a red bar greater than or equal to
control line C and line R.
3. Positive results: The T-line or T-line does not have a red band,
but its color appears lower than the control line C and the control
line.
Limitation of Test Method
1.This kit is a qualitative test and is only used for in vitro
diagnostic support.
2. Make sure that the correct number of samples is added for
testing. Too large or too small a sample may lead to inaccurate
results.
3. Hemolysis, lipidemia, jaundice, and contaminated specimens may
affect test results, so avoid these specimens.
4. Test results for this reagent are for clinical use only and
should not be used as the sole basis for clinical diagnosis and
treatment. The final diagnosis of the disease should be made after
a comprehensive evaluation of all clinical and laboratory results.
Product Performance Indicators
1. Analysis of specificity
1.1 Cross-reaction: Interference with the following types of
antibodies was assessed with the reagents 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: The following substances were added to
the samples at specific concentrations and assessed for their
potential interference with the design of the novel coronavirus
neutralizing antibody test (2019-nCoV). The results show that
different interfering substances will not interfere with the
detection 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 studies: Using the new Coronavirus (2019-nCoV) IgG
Antibody Detection Reagent (colloidal gold method) as contrast
reagent, 120 positive and 300 negative samples were selected for
detection, respectively, and the results were 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 for in vitro diagnostic use only.
2. This product is disposable and cannot be recycled after use.
3. Before the operation, carefully read the instruction manual and
perform the experimental operation in accordance with the reagent
instruction manual.
4. Avoid harsh environments (such as environments containing high
concentration corrosive gases and dust, such as disinfectant,
sodium hypochlorite, acid, alkali, or acetaldehyde). After the
experiment is completed, laboratory disinfection should be
performed.
5. All specimens and used reagents should be handled as potentially
infectious and should be disposed of in accordance with local
regulations in case of rejection.
6. Please use the reagent within the expiry date marked on the
outer carton, and use the test card as soon as possible after
removing 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.
