Sample Requirements
1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended matter in the sample may affect the
experimental results, and should be removed by centrifugation.
3. Anticoagulants: the use of heparin, EDTA and sodium citrate
anticoagulants had no significant effect.
4. Blood collection should be performed by medical professionals.
Serum/plasma testing is recommended as a priority. In emergency or
special circumstances, a 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 8h. They can be stored at 2℃ to 8℃ for 5
days and below -20℃ for 6 months, but repeated freeze-thaw cycles
should be avoided. The whole blood sample shall not be frozen and
stored at 2℃ ~ 8℃ for no more than 48h.
Test Method
Read the instructions carefully before the test. Restore all
reagents to room temperature before testing. The test should be
conducted at room temperature.
1. Take the test card out of the packaged reagent bag and use it
within 1 hour.
2. Add 20μl sample (serum, plasma or whole blood) to the filling
well of the test card, then add 2 drops (about 60μl) sample buffer,
and start timing.
3. Reaction at room temperature for 10 ~ 15 minutes to read the
results. The result was invalid after 20 minutes.
Interpretation of Test Results
Judgment diagram of test card results:
1. Invalid results: no reaction line appeared on the quality
control line (line C), and the test was invalid, so the experiment
should be redone.
2. Negative results: red bands appear on the test line (Line T),
and the color rendering is higher than or equal to the control line
(Line R), quality control line (Line C) and control line (Line R).
3. Positive result: no red band appeared on the test line (Line T)
or red band appeared on the test line (Line T), but the color
rendering was lower than that of the control line (Line R), and the
quality control line (Line C) and the control line (Line R).
Limitation of Test Method
1. This kit is for qualitative detection and is only used for in
vitro auxiliary diagnosis.
2. Make sure you add the right amount of samples for testing. Too
many or too few samples may result in inaccurate results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may
affect 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 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 potential interference of the
following substances in the Novel Coronavirus (2019-nCoV)
neutralizing antibody test program was evaluated by adding the
following substances to a specified concentration sample. The
results showed that all kinds of interfering substances did 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 study: 120 positive samples and 300 negative samples
were selected by using the marketed Novel Coronavirus (2019-nCoV)
IgG detection reagent (colloidal gold method) as the contrast
reagent, 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 only used for in vitro diagnosis.
2. This product is a disposable product, which can not be recycled
and reused after use.
3. Read the operation instructions carefully before operation, and
carry out the experiment in strict accordance with the reagent
instructions.
4. Avoid conducting the experiment in harsh environment (such as
environment containing high concentration of corrosive gas and dust
such as 84 disinfectant, sodium hypochlorite, acid and alkali or
acetaldehyde). Laboratory disinfection should be carried out after
the end of the experiment.
5. All samples and used reagents should be regarded as potentially
infectious substances and disposed of in accordance with local
regulations.
6. Reagents should be used within the validity period marked on the
outer package. The detection card should be used as soon as
possible after it is 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.
