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[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. |
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This kit was used in 2019 for a qualitative test of new corona
virus antigens. Collected from human saliva/sputum samples.
The new corona virus is a new corona virus that may cause viral
pneumonia. Clinical symptoms are fever, fatigue, dry cough, a small
number of patients with nosebleed, runny nose, sore throat,
diarrhea and other symptoms. Severe patients usually develop
dyspnea and/or hypoxemia one week later, as well as severe
patients, acute dyspnea, septic shock, metabolic equivalents, and
accelerated coagulation disorder.
New corona virus antigens, based on suspicious saliva/saliva
sideflimnoasi samples were legalized. Usually, antigens are
detected in saliva/saliva samples during the acute phase of
infection. A positive result indicates the presence of viral
antigens, but additional diagnostic information is needed to
determine clinically relevant infection status between the
patient's history. A positive result does not rule out bacterial
infection or other virus-related infections. The pathogen detected
may not be the correct cause of infection. Negative disease results
do not exclude new coronaviruses acquired in 2019 and should not be
used as a basis for treatment or patient management decisions,
including infection control decisions. In the case of a negative
outcome, the final decision must be made based on the patient's
recent exposure, history, and clinical symptoms. Consistent with
the new corona virus, nucleic acid analysis is needed to confirm
the signs.
The kit consists of test card, sample buffer storage and swab.
Test card: aluminum foil bag, desiccants, test paper, plastic card
paper consists of absorbent paper, nitro fiber membrane, sample
pad, rubber pad, 2019 nitro cotton T line (test line) bag made of
adhesive cloth -NCOV Goat anti-rat polyclonal antibody Ab and C
line (QC line) bag, including the 2019 NCOVAb label binding pad.
Sample buffer: phosphoric acid, nitrile azo, etc.
The temperature is maintained at 2-30 ℃ for 18 months.
The aluminum foil package will remain valid for 1 hour after
opening.
Production Lot Number: Refer to the label for details.
Expiry date: Refer to the label.
(1) Saliva sample collection: Do not eat or drink chewing gum or
cigarette products within 30 minutes after saliva sample
collection. Place your tongue on the lid of your mouth to collect
saliva roots. Place a disposable sterile swab under your saliva.
Sample: Use tongue for at least 10 seconds, immerse completely in
saliva, rotate 5 times or more (see Table 1).
Note: Saliva sample is not collected correctly.
Figure 1 Methodsfor saliva sample collection
Figure 2 Methods for sputum sample collection
(2) Sputum collection: wash the sputum with water, put the sputum
into the test bag after coughing, and wipe the sputum with
disposable sterile cotton swabs (refer to Figure 2).
(3) Sample processing: Collected samples must be processed with the
sample buffer storage contained in the toolbox (samples not
immediately processed must be stored in a dry and germicidal sealed
container). 2-8 degrees Celsius to 24 hours, -70 degrees Celsius
(but please avoid repeated freezing and thawing).
Please read the instructions carefully before the exam. All
reagents are returned to room temperature, and tests must be
performed at room temperature.
Processing example (see Figure 3).
(1) Insert the sample exchanger into the sample buffer storage, the
sample rotates around the inner wall for about 10 times, and the
sample is soluble in solution as far as possible.
(2) Press the front end of the cotton stick along the inner wall,
pour the liquid into the tube, remove the cotton stick and discard
it.
(3) Cover with water droplets.
Figure 3 Sample processing
Figure 4 Test procedure
2. Test process (see Figure 4).
(1) Remove the test card.
(2) Add 2 drops (about 80L) of the processed sample extract into
the sample hole of the test card to start the timer.
(3) Read the card for 15 minutes at room temperature, and the
result is invalid after 20 minutes.
Figure 5 Interpretation of test results
1. This product is a qualitative test intended only to support
INVitro diagnostics.
2. This product is suitable for saliva and sputum samples. Results
of other sample types may be inaccurate or invalid.
3. In the absence of sputum samples, patients should be examined
with a nasopharyngeal swan.
4. Confirm that the appropriate number of additional test samples
has been added. With too many or too many samples, the results may
be incorrect.
5. The test results of the 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 was made after a
comprehensive evaluation of all clinical and examination results.
1. Detection limits: Inactivated SARS-COV-2 virus cultures were
used in this study. The minimum detection limit is 612tcid50/ml.
2. Use the company's standard materials for testing, and the test
results must meet the requirements of the company's standard
materials.
2.1 Qualification rate of positive control: the enterprise actively
controls P1-P5.
2.2 Pass rate of negative control: The company's N1-N10 negative
control test is negative.
2.3 Detection limit: refer to L1-L3, L1 is negative, L2 and L3 are
positive.
2.4 Reproducibility: BOTH J1 and J2 were 10 times positive.
3. Cross-reactivity: To assess potential interference with the 2019
corona virus and antigen detection program, the following
microorganisms and viruses were injected into the sample at the
concentrations shown.
4. Interference: To evaluate potential interference in the
2019-NCOV Ag test procedure, add the following agents at the
specified concentration. The results showed that the various drugs
did not interfere with the test results of the reagent.
5. Hook effect: In the high concentration range of 1.0106
TCID50/mL, no hook effect was observed in 2019-NCOV inactive
culture.
6. Clinical study: RT-PLR sputum reagent was used as a comparative
reagent to detect saliva samples and sputum samples separately. For
each sample size (RT-PLR test), 120 positive and negative samples
were selected and XIUS reagent was used. The results are as
follows:
1. This product is used for INVitro diagnosis.
This product is disposable and can't be reused.
3. Please strictly follow the reagent instructions and read the
instructions carefully before the experiment.
4. Do not perform the test under severe environmental conditions
(including 84 disinfectant, dust, sodium hypochlorite, acid and
alkali, acetaldehyde and other corrosive gases with high
concentration). It needs to be disinfected in the laboratory after
the experiment.
