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diagnostic kit for the new coronavirus 2019-ncov igm

product details

diagnostic kit for the new coronavirus 2019-ncov igm
product name
common name: instructions for the new coronavirus 2019-ncov igm diagnostic kit (latex assay)
packing specifications
1 test / bag, 5 test / bag, 10 test / bag, 20 test / bag, 1 serving / box, 5 test / box, 10 test / box, 20 test / box, 25
people test / box, 30 test / box, 40 test / box, 50 test / box, 100 test / box, 200 test / box.
expected usage
this product is used for the qualitative detection of new coronavirus 2019-ncov igm antibodies in human serum,
plasma or whole blood.
coronaviruses are a large family of viruses that are known to cause colds and more serious diseases such as the
middle east respiratory syndrome (mers) and severe acute respiratory syndrome (sars). coronaviruses are
systematically classified as coronaviridae (coronaviridae). coronaviruses are single-stranded rna viruses with
positive envelopes that infect only human, mouse, pig, cat, dog, and avian vertebrates. the ninth international
committee on classification of virology divided the coronaviridae into three genera, namely, alpha, beta, and
gamma. coronavirus is excreted through respiratory secretions, transmitted through oral fluid, sneeze, contact,
and transmitted through air droplets.
the 2019 new coronavirus, or "2019-ncov", was discovered because of wuhan virus pneumonia cases in 2019,
and was named by the world health organization on january 12, 2020. the new coronavirus is a new coronavirus
strain that has never been found in humans before.
inspection principle
this product is composed of the new coronavirus 2019-ncov specific dominant epitope antigen fixed on a
nitrocellulose membrane, a colored latex-labeled anti-human igm antibody release pad and other reagents. the
latex immunochromatographic technology was used to detect the new coronavirus 2019-ncov antibody in human
serum / plasma / whole blood using the principle of capture method.
during the test, a blood sample is added to the sample well of the kit. the sample is first mixed with the colored
latex-labeled anti-human igm on the release pad, and then chromatographed on a nitrocellulose membrane. if the
sample contains new coronavirus 2019-ncov antibodies, these antibodies will first bind to colored latex-labeled
anti-human igm, so that when the mixture is chromatographed on a nitrocellulose membrane, it will be
immobilized with the new coronavirus 2019-ncov antigen. the detection line (t line) was captured to form a
colored latex-labeled anti-human igm-antibody-antigen immune complex. therefore, a red line appeared on the t
line, which was a positive result. if no new coronavirus 2019-ncov antibody is present in the blood of the subject,
a red line will not be formed on the test line (t line), which is a negative result. the quality control line (c line) on
the test card is coated with goat anti-mouse antibody. under normal circumstances, a red line should appear on
the quality control line(c line) during the test to prove that the test card is working properly.
main ingredients
1) new coronavirus 2019-ncov igm detection test card
2) one sample pipette per test;
3) one bottle of sample dilution per box;
4) instruction manual: 1 copy.
storage conditions and validity
store at 4-30, protected from light, valid for 12 months. do not freeze.sample requirements
1) the applicable sample type for this test kit is serum / plasma / whole blood.
2) the whole blood is drawn according to the standard clinical laboratory method, and serum or plasma is
separated, and hemolysis should be avoided as much as possible during processing.
3) the samples should be tested as soon as possible after collection to avoid leaving them for a long time at room
temperature. if serum or plasma samples cannot be detected immediately, they can be stored at 2-8℃。
4) the sample must be returned to room temperature before testing.
testing method
1) please read the instruction manual carefully before testing.
2) take out the test card, test sample and control, etc., and use it after returning to room temperature. when
everything is ready, tear off the aluminum foil bag, take out the test card and place it on the water platform.
3) add sample:
whole blood sample: add 2 drops of whole blood vertically to the sample well with the sample pipette, and
then add 1-2 drops of sample diluent.
serum / plasma sample: add 1 drop vertically to the sample well with the addition pipette, and then add 1-2
drops of sample dilution solution.
4) timing observation: judge the result 10 minutes after adding the sample, do not observe the result after 20
interpretation of test results
positive: a red line appears on the quality control line (c line) and the detection line (t line). it indicates that the
new coronavirus 2019-ncov antibody is present in the sample.
negative: only the quality control line (c line) has a red line, and the detection line (t line) has no red line. it
means that no new coronavirus 2019-ncov antibody in the sample or new coronavirus 2019-ncov antibody level
is below the detection level.
invalid: no red line appears on the quality control line (c line), indicating failure. it may be due to improper
operation or test card is invalid and should be retried.
positive result negative result
invalid result invalid result
limitations of detection methods
the test results of this product are only used as a supplement for doctors or other diagnosis.
product performance index
1. detection limit: tested with the detection limit reference, the results are all positive.
c t
c t
c t
c t2. precision: test the same sample 5 times, the test results are consistent and the color of line is uniform.
3. positive compliance rate and negative compliance rate:
positive compliance rate: test 3 positive reference samples, the positive compliance rate was 100%;
negative compliance rate: test 10 negative reference materials, the negative compliance rate was 100%.
4. interference test:
when the content of bilirubin in the sample to be tested is less than 200mg / l, there is no interference with
the test results;when the cholesterol in the sample to be tested is less than 2500mg / l, there is no interference
with the test results; when the hemoglobin in the sample is less than 2500mg / l, it does not interfere with the
test results; rheumatoid factor (rf) positive, hepatitis b, hepatitis c, and hepatitis e samples did not interfere with
the test results.
1) this product is for in vitro testing only.
2) if the sample is suspected to be contaminated, re-sampling should be performed.
3) do not use expired kits.
4) all samples shall be treated as infectious materials during the test.
basic information
registrant / manufacturer: gensure biotech inc.,
address: b1-78, rizhongtian science and technology park, no.585 tianshan street, shijiazhuang high-tech
zone, hebei,china.
utill now, chinese goverment has selected 9 products from 8 companies from the 300
companies who declared, and submitted the 9 products to the national medical products
administration of china for emergency approval.
this product is one of the 9 products listed above that have been approved, it was jointly
developed by gensure biotech inc., pla general hospital (301 hospital), tongji hospital affiliated
to tongji medical college of huazhong university of science and technology, tianyou hospital
affiliated to wuhan university of science and technology, second hospital of hebei medical
university and beijing jinwufu biological engineering technology co., ltd.

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