Active Member
|
[China]
Address: Office Address: Building 4, No. 51 Jingbei 3rd Road, Jingkai Zone, Zhengzhou City. Henan Province,China.
Contact name:chen
Henan Lantian Medical Supplies Co.,Ltd. |
|
|
The kit is used for qualitative detection of 2019 NCOV
neutralization
Antibodies in human serum, plasma and whole blood samples
As a new type, 2019 NCOV is a kind of NCOV. The main clinical
symptoms of viral pneumonia are fever, fatigue and dry cough. Some
patients have nasal congestion, runny nose, sore throat, diarrhea
and other symptoms. In severe cases, dyspnea or hypoxemia occurred
one week later, and acute respiratory distress syndrome, septic
shock, metabolic acidosis and coagulation disorder occurred rapidly
in severe cases.
There are several structural proteins in 2019 NCoV, including
spike, envelope protein and membrane protein
(m) and nuclear cosid(n). Among them, spy protein contains receptor
binding domain (RBD), which is involved in identifying angiotensin
converting enzyme 2(ACE 2) on cell surface receptor. It is found
that the peak rbd in 2019 ncov interacts strongly with human aceh 2
receptor, which leads to host cell endocytosis and virus
replication in lung.
2019 NCoV infection or preventive vaccination will trigger an
immune response and produce antibodies in the blood stream.
Secreted antibodies can prevent virus infection. They exist in
human circulation several months to several years after infection,
and they are rapidly combined with pathogens in order to prevent
virus replication. These antibodies are called neutralizing
antibodies. Neutralizing antibody detection can determine whether
people have the ability to resist virus infection.
The kit consists of a test card and a sample buffer.
Test card: It consists of aluminum foil package, desiccant, test
strip and plastic card. The test paper consists of absorbent paper,
cellulose nitrate film, sample pad, bonding pad and rubber plate.
T-line (test line) of cellulose nitrate film is covered with
bonding pad containing ACE 2 protein, C-line (QC-line), AB, R-line
(reference-line), reference AB and marking 2019 NCOV AB.
Sample buffer: phosphate, sodium nitride, etc.
Hold at 2 ℃ ~ 30 ℃ and valid is set to 12 months.
The unsealing period of aluminum foil packaging is effective for 1
hour.
Lot number: see label.
Deadline: see detailed label
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.
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.
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).
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.
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%) | |||
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.
| 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 |
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
