Sold only under the conditions of law number 4737\/2020. EOF notification number 2830000616813.\u00a0<\/b><\/p>\n
THE PRODUCT IS NOT AVAILABLE TO INDIVIDUALS<\/b><\/p>\n
Orders that do not comply with the above conditions will be cancelled.<\/strong><\/p>\n <\/p>\n The Realy Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of specific antigens in Sars-Cov-2 present in the human nasopharynx.<\/p>\n <\/p>\n How to:<\/strong><\/p>\n <\/p>\n Allow test, sample, extraction buffer to come to room temperature <\/p>\n Security measures:<\/strong><\/p>\n <\/p>\n <\/p>\n Performance Characteristics:<\/strong><\/p>\n <\/p>\n Clinical evaluation<\/strong><\/p>\n Table: : Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) vs. PCR<\/p>\n <\/p>\n <\/p>\n <\/td>\n <\/td>\n <\/td>\n <\/p>\n Clinical sensitivity = 201\/209=96.17 % (95%CI* 92.51% to 98.17%) <\/p>\n Limit of Detection (LoD)<\/strong><\/p>\n \u00a0<\/strong><\/p>\n <\/td>\n <\/td>\n <\/td>\n <\/td>\n <\/td>\n <\/p>\n The package has 25 pieces<\/p>\n <\/p>\n
\n(15-30 \u00b0 C) before testing.
\n1.Remove the tester from the sealed aluminum case and use it
\nas soon as possible. Place the tester on a clean and flat surface. The
\nbetter results will be obtained if the analysis is performed immediately after opening
\nof the aluminum case.
\n2. Unscrew the entire cap of the sample collection tube
\n3. Take out 1 bottle of sample extraction buffer, remove the bottle cap,
\nadd all of the extraction buffer to the extraction tube.
\n4.Place the sterile swab specimen in the specimen extraction buffer.
\nRotate the stylus for about 10 seconds while pressing the head in
\nof the tube to release the antigen on the swab.
\n5.Remove the sterile swab while pressing the sterile swab head into
\ninside the tube as you remove it to expel as much liquid as possible
\nfrom the stylus. Dispose of the sterile swab according to the disposal protocol
\nbiohazard waste.
\n6. Screw and tighten the cap on the sample collection tube, then
\nvigorously shake the sample collection tube to mix the sample and the
\nsample extraction buffer. See figure 4.
\n7.Add 3 drops of solution (about 80\u03bcl) to the sample port of the device and to
\nthen start the timer. Read the result in 10~20 minutes. Do not interpret
\nresult after 20 minutes.<\/p>\n\n
\n\u2022Do not use after the expiry date.
\n\u2022 Make sure the test package is not damaged before opening for use.
\n\u2022Perform the test at room temperature 15 to 30\u00b0C.
\n\u2022Wear gloves when handling samples, avoid touching membrane
\nreagent and the sample window.
\n\u2022 All samples and used components should be treated as
\ninfectious and to be disposed of according to local regulations.
\n\u2022Avoid the use of blood samples.<\/li>\n<\/ul>\n
\n<\/strong>A clinical evaluation was performed to compare the results obtained from
\nthe Novel Coronavirus (SARS-Cov-2) Rapid Antigen Test Cassette (Pen) and PCR. The
\nresults are summarized below:<\/p>\n\n\n
\n Method<\/strong><\/td>\n \u00a0 \u00a02019 Test K-nCoV it\u00a0 \u00a0 \u00a0 \u00a0(RT-NPCR ucleic ) Acid<\/strong><\/td>\n \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0<\/strong>Total<\/strong>
\n\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0results<\/strong><\/td>\n<\/td>\n<\/tr>\n \n The Novel Coronavirus<\/strong>
\n(SARS-Cov-2) Antigen Rapid<\/strong>
\nTest Cassette (Swab)<\/strong><\/td>\n\u00a0 \u00a0<\/strong>Results<\/strong><\/td>\n Positive<\/strong><\/td>\n Negative<\/strong><\/td>\n<\/tr>\n \n Positive<\/strong><\/p>\n \u00a0 \u00a0201<\/td>\n 0<\/td>\n 201<\/td>\n<\/tr>\n \n Negative<\/strong><\/p>\n \u00a0 \u00a08<\/td>\n 450<\/td>\n 458<\/td>\n<\/tr>\n \n Overall results<\/strong><\/p>\n \u00a0 \u00a0209<\/td>\n 450<\/td>\n 659<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\nClinical specificity = 450\/450\uff1e99.9% (95%CI* 98.98% to 100%)
\nAccuracy: (201+450)\/ (201+0+8+450) *100%=98.79% (95%CI* 97.58% to 99.43%)
\n*Confidence interval<\/p>\n\n\n
\n 2019-nCoV Strain Tested\u00a0<\/strong><\/p>\n Realy Tech product<\/td>\n <\/td>\n<\/tr>\n \n Stock 2019-nCoV Concentration\u00a0<\/strong><\/p>\n 1 X 106 TCID50\/mL<\/td>\n <\/td>\n<\/tr>\n \n Dilution\u00a0<\/strong><\/p>\n 1\/100<\/td>\n 1\/200<\/td>\n 1\/400<\/td>\n 1\/800<\/td>\n 1\/1600<\/td>\n<\/tr>\n \n Concentration in Dilution tested (TCID50\/ml)\u00a0<\/strong><\/p>\n 1X104<\/td>\n 5X103<\/td>\n 2.5X 103<\/td>\n 1.25X103<\/td>\n 6.25X102<\/td>\n<\/tr>\n \n Call rates of 20 replicates near cut-off\u00a0<\/strong><\/p>\n 100(20\/20)<\/td>\n 100(20\/20)<\/td>\n 100(20\/20)<\/td>\n 95(19\/20)<\/td>\n 10(2\/20)<\/td>\n<\/tr>\n \n Limit of detection (LoD) per Virus Strain\u00a0<\/strong><\/td>\n 1.25 X 103 TCID50\/mL<\/td>\n <\/td>\n <\/td>\n <\/td>\n <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n