2 ~ 30 ℃ for 12 months.
The validity period of aluminum foil is 1 hour after opening.
Configuration number: please refer to the label for details.
Due date: please refer to the label for details.
Sample Requirements
1. Collect serum, plasma or whole blood samples.
2. The sediment and floating matter of the sample will affect the
experimental results and should be removed by centrifugation.
3. Anticoagulant: the use of jellyfish skin, EDTA and sodium
citrate anticoagulant has little effect.
4. Blood collection needs medical experts to complete. Serum /
plasma test is preferred. In case of emergency or special
circumstances, whole blood samples of patients can be used for
rapid examination.
5. Serum and plasma samples should not be stored at room
temperature for more than 8 hours. It can be stored for 6 months at
2 ℃ ~ 8 ℃ for 5 days and below - 20 ℃, but repeated freezing
thawing cycles should be avoided. The whole blood samples should
not be frozen at 2 ℃ ~ 8 ℃ for less than 48 hours.
Test Method
Please read the guide carefully before the test. Please reduce all
the test drugs to room temperature before testing. The test should
be carried out at room temperature.
1. Take out the test card from the packaged test bag and use it
within 1 hour.
2. 20 μ L add the sample (serum, plasma or whole blood) to the
filling hole of the test card, and then drop 2 drops (about 60
drops) μ l) Add sample buffer and start timing.
3. React at room temperature for 10 ~ 15 minutes and read the
results. The results were invalid after 20 minutes.
Interpretation of Test Results
Test card result judgment chart:
1. Invalid results: there is no response line in the quality
management line (line C), the test is invalid, and the experiment
needs to be carried out again.
2. Negative results: the test line (line T) appears red band, and
the color rendering is higher than the control line (line R),
quality management line (line C) and control line (line R).
3. Positive results: the test line (line T) has no red band, or the
test line (line T) has red band, but the color rendering is lower
than the control line (line R), and the quality is decreased.
Control line (line C) and control line (line R).
Limitation of Test Method
This element is only used for in vitro diagnosis.
2. In order to test, it is necessary to add an appropriate amount
of samples. Too many or too few samples can lead to incorrect
results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may
affect the test results and should be avoided.
4. The test results of the reagent are only for clinical reference
and can not be used as the only basis for clinical diagnosis and
treatment. The final diagnosis of the disease must be carried out
after comprehensive evaluation of all clinical and laboratory
results.
Product Performance Indicators
1. Specificity analysis
1.1 cross reaction: the following types of antibody evaluation were
conducted for interference with reagents, and no cross reaction
occurred.
| 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: in the new coronavirus (2019 ncov)
neutralizing antibody test project, the potential interference of
the following substances was evaluated by adding the following
substances to the specific concentration samples. The results
showed that all kinds of interfering substances would 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 research: 120 positive samples and 300 negative samples
were selected from Novell coronavirus (2019 ncov) IgG test reagent
(colloidal gold method) as contrast agent. 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 reused after use.
3. Please read the operation guide carefully before starting, and
carry out the experiment according to the reagent guide.
4. Do not carry out experiments in harsh environment (such as 84
disinfectant, sodium hypochlorite, acid-base or acetaldehyde and
other corrosive gases and dusty environment). The laboratory should
be disinfected after the experiment.
5. All samples and reagents used should be considered as potential
infectious substances and destroyed according to local regulations.
6. The reagent must be used within the validity period marked on
the external package. The sensor card should be used as soon as
possible after it is removed from the aluminum foil bag to prevent
moisture.
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.
