Sample Requirements
1. collected serum, plasma, or whole blood samples.
The sediment and suspended objects in the 2. samples may affect the
experimental results and should be removed by centrifugation.
3. anticoagulation: heparin and EDTA, sodium citrate are not
significant.
4. blood collection shall be conducted by professional medical
personnel. Sera / plasma testing is recommended. Whole blood
samples of patients can also be used for rapid detection in
emergency or special situations.
The 5. serum and plasma samples should not be stored at room
temperature for more than 8 hours. They are out there
It can be stored from 2 to 8 ℃ for 5 days and 6 months below-20 ℃,
but repeated freeze-thaw cycles should be avoided. Whole blood
samples shall not be frozen and shall be kept at 2 ℃ ~8 ℃ for no
more than 48 hours.
Test Method
Read the instructions carefully before testing. Return all reagents
to room temperature at room temperature.
1.The removes the test card from the packaged kit for use within
one hour.
2. adds 20 μL samples (serum, plasma or whole blood) to the loading
hole of the test card, then adds 2 drops (approximately 60 μL)
sample buffer and begins timing.
3. The results were read after 10-15 minutes of reaction at room
temperature. Invalid results after 20 minutes.
Interpretation of Test Results
Figure for judging test card results:
1.Invalid result: quality control line (C) is not reactive and
should be retest.
2. negative result: a red strip appears in the test line (T line),
color color above or equal to baseline line (R line), quality
control line (C line) and baseline line (R line) coloring.
3. positive results: no red band on the test line (T), or less red
band on the test line (T) than reference line (R), mass control
line (C) and reference line (R).
Limitation of Test Method
1. The kit is used for qualitative detection and only for in vitro
assisted diagnosis.
2. ensures that an appropriate amount of samples is added for
testing. Too much or too small the sample size can cause inaccurate
results.
3. hemolytic, lipid blood, 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: evaluate the interference of the following type
of antibody to the reagent and show 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 Interference substances: In 2019-nCoV and in the Ab test
program, add the following concentration to the sample to assess
its potential interference. The results show that the various
interfering substances do not disturb the detection results 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: When the marketed 2019-nCoV IgG Ab test reagent
(colloidal gold method) was used as the control 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 used for in vitro diagnosis only.
2. This product is disposable and cannot be recycled.
3. carefully before operation and conduct experimental operation
strictly according to the reagent instructions.
4. avoids experiments in harsh environmental conditions
(environments containing 84 disinfectant, sodium hypochlorite, high
concentrations of corrosive gases such as acid, alkali, or
acetaldehyde, and dust). Laboratory disinfection shall be performed
after the experiment.
All 5. samples and used reagents shall be considered potentially
infectious substances and treated in accordance with local
regulations.
6. reagents shall be used within the period of validity indicated
on the outer package. The test card shall be used as soon as
possible after removal 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.
