Save at 2 to 30 degrees Celsius, and the effective period is 12
months.
The aluminum foil bag is opened and the effective period is 1H.
Product lot number: see the label for details.
Product invalid date: see the label for details.
Sample Requirements
1 serum, plasma or whole blood samples.
Since precipitates and floatings in the sample may affect the
experimental results, centrifugation must be removed.
Anticoagulants using anticoagulant heparin, EDTA and sodium citrate
were not effective.
4. It is recommended that a professional medical staff should do so
and prioritize serum / plasma examination. In case of an emergency
or a special case, the patient's whole blood sample can also be
used for quick inspection.
5.Serum and plasma samples can not exceed 8h at room temperature,
can be stored at 5 to 8 degrees Celsius for 5 days, and can be kept
at - 20 degrees Celsius for 6 months to avoid repeated freezing and
thawing. The whole blood sample should not be frozen, and should
not be stored above 48 h at 2 to 8 ° C.
Test Method
Please read the usage instructions before the test. Return all
reagents to room temperature before the test. Test should be done
at room temperature.
1. Take out the test card from the packed reagent bag and use it
within 1 hour.
2.Sample (serum, plasma or whole blood) 20 μ 2 drops of sample
buffer solution μ L).
3. Reading after 20 minutes is invalid.
Interpretation of Test Results
Explanation of the test card
1.An invalid result: the quality control line (C line) reaction
line appears, the detection is invalid, and the retest should be
done.
2.Negative result: the red band appears in the inspection line (t
line), and the color is higher than the control line (r line), and
the quality control line (C line) and the control line (r line)
color.
3.Positive result: the red band does not appear in the inspection
line (t line), and the red band appears in the inspection line (t
line), but the color is lower than the control line (r line), and
the quality control line (C line) and the control line (r line)
color.
Limitation of Test Method
1.This kit is a qualitative test and is used only for in vitro
diagnosis.
2. If the number of samples is too small or too small, the result
may be inaccurate.
3. Hemolysis, lipidemia, jaundice, contamination samples should be
avoided because it may affect the test results.
4. The results of this reagent are only provided for clinical
reference and should not be the only basis for clinical practice,
and the final diagnosis should be performed after overall
evaluation of all clinical and laboratory results.
Product Performance Indicators
1. Specificity analysis
1.1Cross reaction: no interference was observed when the
interference was tested for the following types of antibodies.
| 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 In order to evaluate the possibility of interferers, the
following concentrations were added to the specified concentration
samples. As a result, it was shown that various interferences did
not interfere with the detection result 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: a novel test of the normal coronavirus
(2019-ncov) IgG antibody test reagent (colloidal gold method) was
carried out as a comparative reagent, and 120 positive and 300
samples were tested
| 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 for in vitro diagnosis.
2. This product is disposable, and cannot be used again.
3.
Avoid disseminated environments such as 84 disinfectants, sodium
hypochlorite, acid alkaloids, acetaldehyde, and so on.
5. All samples and Empress's reagents are regarded as potential
infectious substances and must be treated according to the local
laws when disposing.
6.The reagent should be used within the effective period of the
display of packaging. Use the soap card from the aluminum foil bag
as soon as possible and 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.
