Sample Requirements
1.A sample of serum, plasma, or whole blood collected.
2.The precipitates and suspended solids in the samples may affect
the experimental results, so they need to be removed by
centrifugation.
3.Anticoagulant therapy: heparin, EDTA and sodium citrate are not
important.
4.Blood collection should be carried out by professional medical
personnel.
Serum / plasma tests are recommended.
Whole blood samples from patients can also be used for rapid
testing in emergency or special situations.
5.Serum and plasma samples should not be stored for more than 8
hours at room temperature.
They're right there.
It can be stored at 2-8 degrees Celsius for 5 days and below-20
degrees Celsius for 6 months, but avoid repeated freeze-thaw
cycles.
Whole blood samples cannot be frozen and must be stored at 2 ℃ to 8
℃ for 48 hours.
Test Method
Please read the instructions carefully before testing.
Restore all reagents to room temperature at room temperature.
1.Remove the test card from the test package for use within 1 hour.
2.Add a sample of 20 μ L (serum, plasma or whole blood) to the
loading hole of the test card, then add 2 drops (about 60 μ L) of
the sample buffer to start the timing.
3.The results were read after the reaction at room temperature for
10 ~ 15 minutes.
The result is invalid after 20 minutes.
Interpretation of Test Results
Figure used to judge the result of test card:
1. Invalid result: the quality management line (c) does not respond
and needs to be retested.
2. Negative result: red band is displayed on the test line (t
line), the color above the baseline (r line), the color of the
quality control line (C line), and the color of the baseline (r
line).
With or without red (R) on the reference line, and the test result
is less than 3 (R) on the reference line.
Limitation of Test Method
1. The kit is only used for qualitative detection and invitro
assisted diagnosis.
2. Confirm that appropriate equivalent samples are added for the
test. Too large or too small sample size may produce inaccurate
results.
3. Hemolytic, lipid blood, jaundice or contaminated samples may
affect the test results, so these samples should be avoided.
4. The test results of this reagent are only for clinical reference
and should not be used as the only basis for clinical diagnosis and
treatment. The final diagnosis of the disease must be made after a
comprehensive evaluation of all clinical and examination 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 |
1.2Interfering substances: in the 2019 ncov and ab test procedures,
the following concentrations were added to the samples to assess
potential interference. The results show that various interfering
substances will not interfere with 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 trial: when using commercial 2019 ncov IgG AB test
reagent (gold colloid method) as control reagent, 120 positive
samples and 300 negative samples were selected for the trial. 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 invitro diagnosis.
2. This product is disposable and cannot be reused.
3. Please pay attention to the experimental operation in strict
accordance with the instructions of the reagent before operation.
4. Avoid experiments under harsh environmental conditions
(including 84 disinfectant, sodium hypochlorite, acid, alkali,
acetaldehyde and other high concentration corrosive gases and
dust). The disinfection of the laboratory should be carried out
after the experiment.
5. All samples and used reagents will be regarded as potentially
infectious substances and treated in accordance with local
regulations.
6. The reagent shall be used within the validity period indicated
on the packing box. The test card should be used as soon as
possible after being removed 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.
