Keep it at 2℃ ~ 30℃, and the validity period is set at 12 months.
The validity period is an hour for aluminum foil bag being
unpacked.
Batch No. : See label for details.
Sample Requirements
1.Collect serum, plasma or whole blood samples.
2.The sediment and suspended matter in the sample may affect the
experimental results, andshould be removed by centrifugation.
3. Anticoagulant: Heparin, EDTA and sodium citrate anticoagulant
have no significant effect.
4. Blood collection should be performed by professional medical
personnel. It is recommended to give priority to serum/plasma test.
In emergency or special circumstances, the patient's whole blood
sample can also be used for rapid test.
5. Serum and plasma samples should not be stored at room
temperature for more than 8h. They can be stored for 5 days at 2℃
to 8℃ and for 6 months below -20℃, but repeated freeze-thaw cycles
should be avoided. Whole blood samples should not be frozen and it
should be stored at 2℃～8℃ for no more than 48h
Test Method
Read the instructions carefully before testing. Please return all
reagents to room temperature before testing, and the test should be
performed at room temperature.
1.Take out the test card from the packaged reagent bag and use it
within an hour.
2.Add 20μL of sample (serum, plasma or whole blood) to the loading
well of the test card, then add 2 drops (about 60μL) of sample
buffer and then start timing.
3. Read the result when reacting at room temperature for 10-15
minutes. The result is invalid after 20 minutes
Interpretation of Test Results
Interpretation of test card:
- Invalid result: It is invalid with no reaction line on the quality
control line (C line), and the test should be carried out again.
- Negative result: A red band appears on the test line (T line), and
the color rendering 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.
- Positive result: No red band appears on the test line (T line), or
the red band on the test line (T line) is less coloring 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
- This kit is for qualitative detection and is only used for in vitro
auxiliary diagnosis.
- Make sure to add an appropriate amount of sample for test. Too much
or too little sample volume may result in inaccurate results.
- Hemolysis, lipemia, jaundice and contaminated samples may affect
the test results, and these samples should be avoided.
- The test results of this reagent are for clinical reference 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
1.1Cross reaction: The following types of antibodies were evaluated
for interference with reagents, and the results showed 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 |
1.2Interfering substances: The following concentrations of
substances were added to the samples at the specified
concentrations to evaluate their potential interference in
2019-nCoV neutralization Ab test project. 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 study: Using the marketed 2019-nCoV IgG Ab detection
reagent (colloidal gold method) as a comparison reagent, 120
positive samples and 300 negative samples were selected for
testing. The results are summarized as follows:
| 2019-nCoV IgG Ab detection reagent (colloidal gold method) |
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
- This product is only used for in vitro diagnosis.
- This product is disposable, which cannot be recycled and reused.
- Read the instructions carefully before operation, and carry out the
experimental operation in strict accordance with the reagent
instructions.
- Avoid conducting experiments in bad environmental conditions (the
environments containing 84 disinfectant, sodium hypochlorite,
high-concentration corrosive gases such as acid and alkali or
acetaldehyde, and dust). Laboratory disinfection should be carried
out after the experiment.
- All samples and used reagents should be regarded as potentially
infectious substances and disposed of in accordance with local
regulations.
- Reagents should be used within the validity period marked on the
outer package. The test card should be used as soon as possible
after being taken out of 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.
