Sample Requirements
(1) Saliva sample collection: Do not eat or drink gum or tobacco
products within 30 minutes after saliva sample collection. Rest the
tip of the tongue on the palate to collect the saliva roots.
Disposable sterile cotton swabs are placed under a saliva sample.
Use the tip of the tongue for at least 10 seconds, completely
immersed in saliva, spinning more than 5 times. (See Table 1)
Note: If the saliva sample is taken incorrectly.
Figure 1 Methodsfor saliva sample collection
Figure 2 Methods for sputum sample collection
(2) Sputum specimen collection: rinse with water, cough up phlegm,
put it into a specimen bag, and wipe the specimen with a disposable
sterile cotton swab. (See Figure 2)
(3) Sample Handling: Handle collected samples using the sample
buffer provided in this kit (samples not disposed of immediately
should be stored in dry, sterile, and sealed containers). 2-8
degrees Celsius to 24 hours, more than 70 degrees Celsius (but
avoid repeated freezing and thawing).
Test Method
Read the instruction manual carefully before testing. Place all
reagents back at room temperature and test at room temperature.
Example processing (see Figure 3).
(1) Insert the sample swab into the sample buffer, rotate the
sample about 10 times near the inner wall, and dissolve the sample
in solution as much as possible.
(2) Press the swab head along the inner wall so that the liquid
flows into the pipe, remove the swab and discard.
(3) Cover with small 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 (~80L) of treated sample extract to the sample
wells of the test card and start timing.
(3) Read the card at room temperature for 15 minutes, and the
result is invalid after 20 minutes.
Interpretation of Test Results
Test card description (see Figure 5):
1. Result: The quality control line (C line) should be rechecked.
2. Negative results: quality control line (C line), red ribbon,
coloring.
3. Positive result: There are two red stripes on the detection line
(T line) and the quality control line (C line).
Figure 5 Interpretation of test results
Limitation of Test Method
1. This product is a qualitative test and is only used to assist in
in vitro diagnosis.
2. This product is suitable for saliva and sputum samples, other
types of samples may have inaccurate or invalid sample results.
3. If the patient does not have a sputum sample, a nasopharyngeal
swab should be used for testing.
4. Make sure to add an appropriate amount of sample for testing. Or
too many samples can lead to inaccurate results.
5. The test results of this reagent are for clinical reference only
and should not be used as the sole basis for clinical diagnosis and
treatment. A comprehensive evaluation of all clinical and
laboratory results resulted in a definitive diagnosis of the
disease.
Product Performance Indicators
1. Detection limit: This study used inactivated SARS-COV-2 virus
cultures. The minimum detection limit is 6102 tcid50/ml.
2. The test adopts the company's standard materials, and the test
results should meet the requirements of the company's standard
materials.
2.1 Actively control the pass rate: Enterprises actively control
p1-p5.
2.2 Negative control pass rate: Our n1-n10 negative control test
was negative.
2.3 Detection limit: refer to L1-L3, L1 is negative, L2 and L3 are
positive.
2.4 Reproducibility: J1 and J2 are 10 times positive.
3 Cross-reaction: The following microorganisms and viruses are
injected into samples at specific concentrations to evaluate their
potential interference with the 2019 novel coronavirus antigen
detection procedures.
4. Interference: Evaluate potential interference in the 2019 nCoV
Ag detection procedure and add the following drugs at the
prescribed concentration. The results show that various drugs do
not interfere with the detection results of the reagents.
5. Hook effect: No hook effect in the high concentration range of
1.0106 TCID50/mL.
6. Clinical research: RT-PCR sputum reagent was used as a control
reagent to detect saliva and sputum samples respectively. For each
sample size (RT-PCR test), 120 positive and negative samples are
selected and a second test is performed using XIUS reagents. The
findings are summarized below:
Precautions
1. This product is used for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Please strictly follow the instructions for reagents, please
read the instructions carefully before the experiment.
4. Avoid testing under harsh environmental conditions (including
high concentrations of corrosive gases, such as 84 disinfectants,
dust, sodium hypochlorite, acid and alkali, acetaldehyde, etc.).
Laboratory disinfection should be performed after the end of the
experiment.
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.
