Sample Requirements
1. collected serum, plasma or whole blood samples.
2. Sediments and suspended solids in samples will affect the
experimental results and must be removed by centrifugal separation.
Anticoagulant therapy: heparin, EDTA and sodium citrate are not
important.
3. Blood collection shall be conducted by professional medical
personnel. Serum/plasma testing is recommended. Patients' whole
blood samples can also be used for rapid detection under emergency
or special circumstances.
Serum and plasma samples shall not be stored for more than 8 hours
at room temperature. They're right there
It can be stored at 2-8 C, 5 days C and 6 months C, but repeated
freeze-thaw cycles must be avoided. Whole blood samples are not
frozen and must be kept at 2℃ ~ 8℃ for more than 48 hours.
Test Method
Please read the instructions carefully before testing. All reagents
were restored to room temperature at room temperature.
1.Remove the test card from the packaging kit within one hour.
2.Add l sample (serum, plasma or whole blood) to the loading well,
then add 2 drops (about 60 drops) to the μ test card, start the μ
sample buffering, and start the timing.
3. The results were obtained after 10 ~ 15 minutes of reaction at
room temperature, but the results were invalid after 20 minutes.
Interpretation of Test Results
Test card result judgment chart
1. invalid result: the quality control line (c) is invalid and
needs to be re-tested.
2. Negative results: the color of red stripe appears above or above
the test line (T line), baseline (R line), quality control line (C
line) and baseline line (R line).
3.Positive result: red band on test line (t), or the following red
band on test line (t), instead of reference line (r), mass control
line (c) and reference line (r).
Limitation of Test Method
1. The kit is not only used for qualitative detection, but also for
auxiliary diagnosis in vitro.
2. Add a proper amount of samples in advance for testing. Too many
or too small samples may lead to inaccurate results.
3.Hemolysis, blood lipid, jaundice and contaminated samples may
affect the test results, so avoid these samples.
4.It should not be the only basis for clinical trials and
treatments. The final diagnosis of the disease should be carried
out after comprehensive evaluation of all clinical and experimental
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 the 2019 NCoV and AB test plan, the
following concentrations were added to the samples to evaluate
their potential interference. The results show that various
interfering substances will not interfere with the detection
results of reagents.
| 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 when the commercial 2020 ncov igg ab test reagent
(colloidal gold method) was used as control reagent. 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 disposable and cannot be recycled.
3. In strict accordance with the reagent instructions before
surgery, and experiment.
4. Avoid conducting experiments under harsh environmental
conditions (environment containing 84 kinds of disinfectants,
sodium hypochlorite, corrosive gases and dust with high
concentration such as acid, alkalinity and acetaldehyde). Disinfect
after the experiment.
5. Samples and reagents used are regarded as potentially infectious
substances and treated according to local regulations.
6. Reagents shall be used within the validity period of outsourcing
label. To prevent moisture, the test card must be removed from the
aluminum foil bag and used as soon as possible.
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.
