Sample Requirements
1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended matter in the sample may affect the
results of the experiment and should be removed by centrifugation.
3. Anticoagulant: The use of heparin, EDTA and sodium citrate
anticoagulant has no significant effect.
4. Blood collection should be performed by professional medical
personnel. It is recommended to give priority to serum/plasma
testing. In emergency or special circumstances, the patient's whole
blood sample can also be used for rapid testing.
5. Serum and plasma samples should not be stored at room
temperature for more than 8 hours. They can be stored at 2°C to 8°C
for 5 days, and at -20°C they can be stored for 6 months but avoid
repeated freezing and thawing. Whole blood samples should not be
frozen and stored at 2℃～8℃ for no more than 48h.
Test Method
Read the instruction manual carefully before testing. Please return
all reagents to room temperature before the test, and the test
should be performed at room temperature.
1. Take out the test card from the packaged reagent bag and use it
within 1 hour.
2. Add 20μL of sample (serum, plasma or whole blood) to the sample
hole of the test card, and then add 2 drops (about 60μL) of sample
buffer to start timing.
3. Read the result when reacting at room temperature for 10-15
minutes. The read result is invalid after 20 minutes.
Interpretation of Test Results
Test card result judgment icon:
1. Invalid result: the quality control line (line C) has no
response line, and the test is invalid. The experiment should be
repeated.
2. Negative result: A red band appears on the test line (T line),
and the color is higher than or equal to the control line (R line),
and the quality control line (C line) and control line (R line) are
colored.
3. Positive result: there is no red band on the test line (T line)
or red band on the test line (T line), but the color is lower than
the control line (R line), the quality control line (C line) and
the control line (R Line) color development.
Limitation of Test Method
1. This kit is a qualitative test and is only used for in vitro
auxiliary diagnosis.
2. Make sure to add an appropriate amount of sample for testing.
Too much or too little sample size may cause inaccurate results.
3. Hemolysis, lipemia, jaundice and contaminated samples may affect
the test results, and these samples should be avoided.
4. 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
1.1 Cross-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 |
1.2 Interfering substances: The following substances were added to
the specified concentration samples to evaluate their potential
interference in the new coronavirus (2019-nCoV) neutralization
antibody test project. The results show that various interfering
substances will 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: Using the marketed new coronavirus
(2019-nCoV) IgG antibody 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 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 one-time use product, after use, it cannot be
recycled and reused.
3. Read the instruction manual carefully before operation, and
carry out the experimental operation in strict accordance with the
reagent manual.
4. Avoid conducting experiments in harsh environments (such as
environments containing 84 disinfectant, sodium hypochlorite,
acid-base or acetaldehyde and other high-concentration corrosive
gases and dust) conditions. Laboratory disinfection should be
performed after the experiment.
5. All samples and reagents after use should be regarded as
potentially infectious substances, and should be disposed of in
accordance with local regulations when they are discarded.
6. Please use the reagents within the validity period indicated on
the outer packaging, and use the test card as soon as possible
after taking it 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.
