I SARS-CoV-2 Antigen Test Kit (LFIA) Jiangsu Medomics Medical Technology Co., Ltd. Clinical Evaluation Report Date of Issue: Oct. 15, 2020 Sponsor: Jiangsu Medomics Medical Technology Co., Ltd. F3, Building C, No.3-1 XinjinhuRoad, Jiangbei New Area, 210000, Nanjing, Jiangsu, P.R.China
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I
SARS-CoV-2 Antigen Test Kit (LFIA)
Jiangsu Medomics Medical Technology Co., Ltd.
Clinical Evaluation Report
Date of Issue: Oct. 15, 2020
Sponsor: Jiangsu Medomics Medical Technology Co., Ltd.
F3, Building C, No.3-1 XinjinhuRoad, Jiangbei New Area, 210000, Nanjing, Jiangsu,
P.R.China
II
Content
1. Introduction and Description of the Assay........................................... III
2. Evaluation Method.................................................................................. III
3. Clinical Sample........................................................................................ III
4. Clinical Trial Period................................................................................IV
5. Results and Analysis................................................................................IV
6. Conclusion................................................................................................ VI
Annex I Clinical Verification Data List......................................................VII
III
1. Introduction and Description of the Assay
Medomics SARS-CoV-2 Antigen Test Kit (LFIA) is intended for rapid, qualitative
detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen (Ag)
extracted from the swab specimen in vitro with an immunochromatographic assay.
Medomics SARS-CoV-2 Antigen Test Kit (LFIA) is based on the test principle of
colloidal gold immunochromatography and a double antibody sandwich assay for
determination of SARS-CoV-2 antigen extracted from the swab specimen. The test
cassette contains (1) colloidal gold-labeled anti-SARS-CoV-2 antibody, (2) one detection
line (T line) and one quality control line (C) fixed on a nitrocellulose membrane. T is
fixed with another anti-SARS-CoV-2 antibody for detecting the novel coronavirus. The
quality control antibody is fixed on the C line.
When the appropriate amount of test sample treated with lysis buffer is added to the
sample well of the test cassette, the sample will move forward along the test strip via
capillary action. If the sample contains the novel coronavirus antigens and concentration
of antigens is higher than the limit of detection, the antigen will bind to the colloidal gold-
labeled anti-SARS-CoV-2 antibody. The immune complex will be captured by another
anti-SARS-CoV-2 antibody immobilized on the membrane in the Test Region (T),
forming a red T line and indicating a positive result for the novel coronavirus. If the
sample contains no novel coronavirus antigens or the antigens concentration is lower than
the limit of detection, a negative result is displayed.
Additionally, the test cassette also contains a quality control line C in the Control Region
(C). Regardless of what antigens are present the C line should appear to indicate that the
sample has been transported properly through the membrane. If the C line does not appear
it indicates that the test result is invalid and the sample is required to retest.
2. Evaluation Method
In this study, based on the real-time Polymerase Chain Reaction (RT-PCR) assay as
contrastive method, clinical application study of Medomics SARS-CoV-2 Antigen Test
Kit (LFIA) was performed to verify the safety and effectiveness.
3. Clinical Sample
A total of 843 clinical samples ( 627 nasopharyngeal or throat swabs and 216 anterior
nasal swabs) were validated at Jiangsu Provincial Center for Disease Control and
IV
Prevention (Jiangsu CDC), Nanjing, China. Two swabs were collected from one person
and were tested with Medomics SARS-CoV-2 Antigen Test Kit (LFIA) and 2019-nCoV
RT-PCR kit separately. All swabs were stored at -80℃.
4. Clinical Trial Period
October 08 to October 15, 2020
5. Results and Analysis
5.1 Test procedure
Throughout the evaluation, all samples should be tested with the Medomics SARS-CoV-2
Antigen Test Kit (LFIA) according to the Instruction for Use.
SARS-CoV-2 Antigen Test Kit (LFIA) Lot Number： 2020072201, expiration DATE:
20220722
2019-nCoV RT-PCR kit manufactured by Shanghai BioGerm Medical Technology Co.,
Ltd. was used for diagnosis. The kits were approved by The National Medical Products
Administration (NMPA), NMPA registration # 20203400065.
5.2 Comparative Analysis of Results
Trial Completion
A total of 220 PCR positive cases and 407 PCR negative cases were included in this trial.
Major Effectiveness Statistical Methods
Compared with RT-PCR results, the sensitivity, specificity, positive predictive value
(PPV), negative predictive value (NPV), accuracy and the 95% confidence interval (CI) of
test kit were analyzed. Confidence intervals for sensitivity, specificity, PPV, NPV and
accuracy are calculated per a score method described in CLSI EP12-A2 (2008).
Sensitivity, specificity, PPV, NPV, accuracy: range from 0%~100%, the closer the value
is to 100%, the higher the degree of compliance with clinical diagnosis.
5.3 Result Analysis
Test results are shown as Table 1and Table2, clinical results are detailed in Annex I
Clinical verification data list.
Table 1: 2×2 Contingency Table Analysis of RT-PCR Results and Evaluation Reagent
Test Results for nasopharyngeal or throat swabs .
V
RT-PCR
Medomics
COVID-19 Ag testPositive Negative Total
Positive 215 2 217
Negative 5 405 410
Total 220 407 627
Sensitivity: 97.73% (94.78%~99.26%)
Specificity: 99.51% (98.24%~99.94%)
PPV: 99.08% (96.71%~99.89%)
NPV: 98.78% (97.18%~99.60%)
Accuracy: 98.88% (97.71%~99.55%)
Table 2: 2×2 Contingency Table Analysis of RT-PCR Results and Evaluation Reagent
Test Results for anterior nasal swabs.
RT-PCR
Medomics
COVID-19 Ag testPositive Negative Total
Positive 107 1 108
Negative 5 103 108
Total 112 104 216
Sensitivity: 95.54% (89.89%～98.53%)
Specificity: 99.04% (94.76%～99.98%)
PPV: 99.07% (94.95%～99.98%)
NPV: 95.37% (89.53%～98.48%)
Accuracy: 97.22% (94.05%～98.97%)
Explanation of terms
Sensitivity = True Positives / (True Positives + False Negatives)
Specificity = True Negatives / (True Negatives + False Positives)
PPV (Positive Predictive Value) = True Positives / (True Positives + False Positives)
NPV (Negative Predictive Value) = True Negatives / (True Negatives + False Negatives)
Accuracy = (Tue Negatives + True Positives) / Total Samples
VI
The performance of Medomics COVID-19 Antigen Test Kit (LFIA) was established with
627 nasopharyngeal or throat swabs collected from clinical patients. The SARS-CoV-2
antigen detection results of 215 positive samples and 405 negative samples were
consistent with RT-PCR results. 5 cases were confirmed RT-PCR positive and mean
while tested negative by Medomics SARS-CoV-2 Antigen Test Kit (LFIA) and 2 case
was confirmed RT-PCR negative and meanwhile tested positive by Medomics SARS-
CoV-2 Antigen Test Kit (LFIA).
The performance of Medomics COVID-19 Antigen Test Kit (LFIA) was established with
216 anterior nasal swabs collected from clinical patients. The SARS-CoV-2 antigen
detection results of 107 positive samples and 103 negative samples were consistent with
RT-PCR results. 5 cases were confirmed RT-PCR positive and mean while tested
negative by Medomics SARS-CoV-2 Antigen Test Kit (LFIA) and 1 case was confirmed
RT-PCR negative and meanwhile tested positive by Medomics SARS-CoV-2 Antigen
Test Kit (LFIA).
6. Conclusion
The results from 843 clinical samples show that SARS-CoV-2 Antigen Test Kit (LFIA)
developed by Medomics meet the requirement of clinical intended use.
VII
Annex I Clinical Verification Data List
Results of negative samples for nasopharyngeal or throat swabs:
Sample Data of testing MedomicsAg test result RT-PCR result Coincidence
1 8-Oct-20 N N Yes2 8-Oct-20 N N Yes3 8-Oct-20 N N Yes4 8-Oct-20 N N Yes5 8-Oct-20 N N Yes6 8-Oct-20 N N Yes7 8-Oct-20 N N Yes8 8-Oct-20 N N Yes9 8-Oct-20 N N Yes10 8-Oct-20 N N Yes11 8-Oct-20 N N Yes12 8-Oct-20 N N Yes13 8-Oct-20 N N Yes14 8-Oct-20 N N Yes15 8-Oct-20 N N Yes16 8-Oct-20 N N Yes17 8-Oct-20 N N Yes18 8-Oct-20 N N Yes19 8-Oct-20 N N Yes20 8-Oct-20 N N Yes21 8-Oct-20 N N Yes22 8-Oct-20 N N Yes23 8-Oct-20 N N Yes24 8-Oct-20 N N Yes25 8-Oct-20 N N Yes26 8-Oct-20 N N Yes27 8-Oct-20 N N Yes28 8-Oct-20 N N Yes29 8-Oct-20 N N Yes30 8-Oct-20 N N Yes31 8-Oct-20 N N Yes32 8-Oct-20 N N Yes33 8-Oct-20 N N Yes34 8-Oct-20 N N Yes35 8-Oct-20 N N Yes36 8-Oct-20 N N Yes37 8-Oct-20 N N Yes38 8-Oct-20 N N Yes
VIII
39 8-Oct-20 N N Yes40 8-Oct-20 N N Yes41 8-Oct-20 N N Yes42 8-Oct-20 N N Yes43 8-Oct-20 N N Yes44 8-Oct-20 N N Yes45 8-Oct-20 N N Yes46 8-Oct-20 N N Yes47 8-Oct-20 N N Yes48 8-Oct-20 N N Yes49 8-Oct-20 N N Yes50 8-Oct-20 N N Yes51 8-Oct-20 N N Yes52 8-Oct-20 N N Yes53 8-Oct-20 N N Yes54 8-Oct-20 N N Yes55 8-Oct-20 N N Yes56 8-Oct-20 N N Yes57 8-Oct-20 N N Yes58 8-Oct-20 N N Yes59 8-Oct-20 N N Yes60 8-Oct-20 N N Yes61 8-Oct-20 N N Yes62 8-Oct-20 N N Yes63 9-Oct-20 N N Yes64 9-Oct-20 N N Yes65 9-Oct-20 N N Yes66 9-Oct-20 N N Yes67 9-Oct-20 N N Yes68 9-Oct-20 N N Yes69 9-Oct-20 N N Yes70 9-Oct-20 N N Yes71 9-Oct-20 N N Yes72 9-Oct-20 N N Yes73 9-Oct-20 N N Yes74 9-Oct-20 N N Yes75 9-Oct-20 N N Yes76 9-Oct-20 N N Yes77 9-Oct-20 N N Yes78 9-Oct-20 N N Yes79 9-Oct-20 N N Yes80 9-Oct-20 N N Yes
IX
81 9-Oct-20 N N Yes82 9-Oct-20 N N Yes83 9-Oct-20 N N Yes84 9-Oct-20 N N Yes85 9-Oct-20 N N Yes86 9-Oct-20 N N Yes87 9-Oct-20 N N Yes88 9-Oct-20 N N Yes89 9-Oct-20 N N Yes90 9-Oct-20 N N Yes91 9-Oct-20 N N Yes92 9-Oct-20 N N Yes93 9-Oct-20 N N Yes94 9-Oct-20 N N Yes95 9-Oct-20 N N Yes96 9-Oct-20 N N Yes97 9-Oct-20 N N Yes98 9-Oct-20 N N Yes99 9-Oct-20 N N Yes100 9-Oct-20 N N Yes101 9-Oct-20 N N Yes102 9-Oct-20 N N Yes103 9-Oct-20 N N Yes104 9-Oct-20 N N Yes105 9-Oct-20 N N Yes106 9-Oct-20 N N Yes107 9-Oct-20 N N Yes108 9-Oct-20 N N Yes109 9-Oct-20 N N Yes110 9-Oct-20 N N Yes111 9-Oct-20 N N Yes112 9-Oct-20 N N Yes113 9-Oct-20 N N Yes114 9-Oct-20 N N Yes115 9-Oct-20 N N Yes116 9-Oct-20 N N Yes117 9-Oct-20 N N Yes118 9-Oct-20 N N Yes119 9-Oct-20 N N Yes120 9-Oct-20 N N Yes121 10-Oct-20 N N Yes122 10-Oct-20 N N Yes
X
123 10-Oct-20 N N Yes124 10-Oct-20 N N Yes125 10-Oct-20 N N Yes126 10-Oct-20 N N Yes127 10-Oct-20 N N Yes128 10-Oct-20 N N Yes129 10-Oct-20 N N Yes130 10-Oct-20 N N Yes131 10-Oct-20 N N Yes132 10-Oct-20 N N Yes133 10-Oct-20 N N Yes134 10-Oct-20 N N Yes135 10-Oct-20 N N Yes136 10-Oct-20 N N Yes137 10-Oct-20 N N Yes138 10-Oct-20 N N Yes139 10-Oct-20 N N Yes140 10-Oct-20 N N Yes141 10-Oct-20 N N Yes142 10-Oct-20 N N Yes143 10-Oct-20 N N Yes144 10-Oct-20 N N Yes145 10-Oct-20 N N Yes146 10-Oct-20 N N Yes147 10-Oct-20 N N Yes148 10-Oct-20 N N Yes149 10-Oct-20 N N Yes150 10-Oct-20 N N Yes151 10-Oct-20 N N Yes152 10-Oct-20 N N Yes153 10-Oct-20 N N Yes154 10-Oct-20 N N Yes155 10-Oct-20 N N Yes156 10-Oct-20 N N Yes157 10-Oct-20 N N Yes158 10-Oct-20 N N Yes159 10-Oct-20 N N Yes160 10-Oct-20 N N Yes161 10-Oct-20 N N Yes162 10-Oct-20 N N Yes163 10-Oct-20 N N Yes164 10-Oct-20 N N Yes
XI
165 10-Oct-20 N N Yes166 10-Oct-20 N N Yes167 10-Oct-20 N N Yes168 10-Oct-20 N N Yes169 10-Oct-20 N N Yes170 10-Oct-20 N N Yes171 10-Oct-20 N N Yes172 10-Oct-20 N N Yes173 10-Oct-20 N N Yes174 10-Oct-20 N N Yes175 10-Oct-20 N N Yes176 10-Oct-20 N N Yes177 10-Oct-20 P N No178 10-Oct-20 N N Yes179 10-Oct-20 N N Yes180 10-Oct-20 N N Yes181 10-Oct-20 N N Yes182 10-Oct-20 N N Yes183 10-Oct-20 N N Yes184 10-Oct-20 N N Yes185 10-Oct-20 N N Yes186 10-Oct-20 N N Yes187 10-Oct-20 N N Yes188 10-Oct-20 N N Yes189 10-Oct-20 N N Yes190 10-Oct-20 N N Yes191 10-Oct-20 N N Yes192 10-Oct-20 N N Yes193 10-Oct-20 N N Yes194 11-Oct-20 N N Yes195 11-Oct-20 N N Yes196 11-Oct-20 N N Yes197 11-Oct-20 N N Yes198 11-Oct-20 N N Yes199 11-Oct-20 N N Yes200 11-Oct-20 N N Yes201 11-Oct-20 N N Yes202 11-Oct-20 N N Yes203 11-Oct-20 N N Yes204 11-Oct-20 N N Yes205 11-Oct-20 N N Yes206 11-Oct-20 N N Yes
XII
207 11-Oct-20 N N Yes208 11-Oct-20 N N Yes209 11-Oct-20 N N Yes210 11-Oct-20 N N Yes211 11-Oct-20 N N Yes212 11-Oct-20 N N Yes213 11-Oct-20 N N Yes214 11-Oct-20 N N Yes215 11-Oct-20 N N Yes216 11-Oct-20 N N Yes217 11-Oct-20 N N Yes218 11-Oct-20 N N Yes219 11-Oct-20 N N Yes220 11-Oct-20 N N Yes221 11-Oct-20 N N Yes222 11-Oct-20 N N Yes223 11-Oct-20 N N Yes224 11-Oct-20 N N Yes225 11-Oct-20 N N Yes226 11-Oct-20 N N Yes227 11-Oct-20 N N Yes228 11-Oct-20 N N Yes229 11-Oct-20 N N Yes230 11-Oct-20 N N Yes231 11-Oct-20 N N Yes232 11-Oct-20 N N Yes233 11-Oct-20 N N Yes234 11-Oct-20 N N Yes235 11-Oct-20 N N Yes236 11-Oct-20 N N Yes237 11-Oct-20 N N Yes238 11-Oct-20 N N Yes239 11-Oct-20 N N Yes240 11-Oct-20 N N Yes241 11-Oct-20 N N Yes242 11-Oct-20 N N Yes243 11-Oct-20 N N Yes244 11-Oct-20 N N Yes245 11-Oct-20 N N Yes246 11-Oct-20 N N Yes247 11-Oct-20 N N Yes248 11-Oct-20 N N Yes
XIII
249 11-Oct-20 N N Yes250 11-Oct-20 N N Yes251 11-Oct-20 N N Yes252 11-Oct-20 N N Yes253 11-Oct-20 N N Yes254 11-Oct-20 N N Yes255 11-Oct-20 N N Yes256 11-Oct-20 N N Yes257 11-Oct-20 N N Yes258 11-Oct-20 N N Yes259 11-Oct-20 N N Yes260 11-Oct-20 N N Yes261 11-Oct-20 N N Yes262 11-Oct-20 N N Yes263 11-Oct-20 N N Yes264 11-Oct-20 N N Yes265 11-Oct-20 N N Yes266 11-Oct-20 N N Yes267 11-Oct-20 N N Yes268 11-Oct-20 N N Yes269 11-Oct-20 N N Yes270 11-Oct-20 N N Yes271 12-Oct-20 N N Yes272 12-Oct-20 N N Yes273 12-Oct-20 N N Yes274 12-Oct-20 N N Yes275 12-Oct-20 N N Yes276 12-Oct-20 N N Yes277 12-Oct-20 N N Yes278 12-Oct-20 N N Yes279 12-Oct-20 N N Yes280 12-Oct-20 N N Yes281 12-Oct-20 P N No282 12-Oct-20 N N Yes283 12-Oct-20 N N Yes284 12-Oct-20 N N Yes285 12-Oct-20 N N Yes286 12-Oct-20 N N Yes287 12-Oct-20 N N Yes288 12-Oct-20 N N Yes289 12-Oct-20 N N Yes290 12-Oct-20 N N Yes
XIV
291 12-Oct-20 N N Yes292 12-Oct-20 N N Yes293 12-Oct-20 N N Yes294 12-Oct-20 N N Yes295 12-Oct-20 N N Yes296 12-Oct-20 N N Yes297 12-Oct-20 N N Yes298 12-Oct-20 N N Yes299 12-Oct-20 N N Yes300 12-Oct-20 N N Yes301 12-Oct-20 N N Yes302 12-Oct-20 N N Yes303 12-Oct-20 N N Yes304 12-Oct-20 N N Yes305 12-Oct-20 N N Yes306 12-Oct-20 N N Yes307 12-Oct-20 N N Yes308 12-Oct-20 N N Yes309 12-Oct-20 N N Yes310 12-Oct-20 N N Yes311 12-Oct-20 N N Yes312 12-Oct-20 N N Yes313 12-Oct-20 N N Yes314 12-Oct-20 N N Yes315 12-Oct-20 N N Yes316 12-Oct-20 N N Yes317 12-Oct-20 N N Yes318 12-Oct-20 N N Yes319 12-Oct-20 N N Yes320 12-Oct-20 N N Yes321 12-Oct-20 N N Yes322 12-Oct-20 N N Yes323 12-Oct-20 N N Yes324 12-Oct-20 N N Yes325 12-Oct-20 N N Yes326 12-Oct-20 N N Yes327 12-Oct-20 N N Yes328 13-Oct-20 N N Yes329 13-Oct-20 N N Yes330 13-Oct-20 N N Yes331 13-Oct-20 N N Yes332 13-Oct-20 N N Yes
XV
333 13-Oct-20 N N Yes334 13-Oct-20 N N Yes335 13-Oct-20 N N Yes336 13-Oct-20 N N Yes337 13-Oct-20 N N Yes338 13-Oct-20 N N Yes339 13-Oct-20 N N Yes340 13-Oct-20 N N Yes341 13-Oct-20 N N Yes342 13-Oct-20 N N Yes343 13-Oct-20 N N Yes344 13-Oct-20 N N Yes345 13-Oct-20 N N Yes346 13-Oct-20 N N Yes347 13-Oct-20 N N Yes348 13-Oct-20 N N Yes349 13-Oct-20 N N Yes350 13-Oct-20 N N Yes351 13-Oct-20 N N Yes352 13-Oct-20 N N Yes353 13-Oct-20 N N Yes354 13-Oct-20 N N Yes355 13-Oct-20 N N Yes356 13-Oct-20 N N Yes357 13-Oct-20 N N Yes358 13-Oct-20 N N Yes359 13-Oct-20 N N Yes360 13-Oct-20 N N Yes361 13-Oct-20 N N Yes362 13-Oct-20 N N Yes363 13-Oct-20 N N Yes364 13-Oct-20 N N Yes365 13-Oct-20 N N Yes366 13-Oct-20 N N Yes367 13-Oct-20 N N Yes368 13-Oct-20 N N Yes369 13-Oct-20 N N Yes370 13-Oct-20 N N Yes371 13-Oct-20 N N Yes372 13-Oct-20 N N Yes373 13-Oct-20 N N Yes374 13-Oct-20 N N Yes
XVI
375 13-Oct-20 N N Yes376 13-Oct-20 N N Yes377 13-Oct-20 N N Yes378 13-Oct-20 N N Yes379 13-Oct-20 N N Yes380 13-Oct-20 N N Yes381 13-Oct-20 N N Yes382 13-Oct-20 N N Yes383 13-Oct-20 N N Yes384 13-Oct-20 N N Yes385 13-Oct-20 N N Yes386 13-Oct-20 N N Yes387 13-Oct-20 N N Yes388 13-Oct-20 N N Yes389 13-Oct-20 N N Yes390 13-Oct-20 N N Yes391 13-Oct-20 N N Yes392 13-Oct-20 N N Yes393 13-Oct-20 N N Yes394 13-Oct-20 N N Yes395 13-Oct-20 N N Yes396 13-Oct-20 N N Yes397 13-Oct-20 N N Yes398 13-Oct-20 N N Yes399 13-Oct-20 N N Yes400 13-Oct-20 N N Yes401 13-Oct-20 N N Yes402 13-Oct-20 N N Yes403 13-Oct-20 N N Yes404 13-Oct-20 N N Yes405 13-Oct-20 N N Yes406 13-Oct-20 N N Yes407 13-Oct-20 N N Yes
Results of negative samples for anterior nasal swabs :
Sample Data of testing MedomicsAg test result RT-PCR result Coincidence
1 14-Oct-20 N N Yes2 14-Oct-20 N N Yes3 14-Oct-20 N N Yes4 14-Oct-20 N N Yes5 14-Oct-20 N N Yes
XVII
6 14-Oct-20 N N Yes7 14-Oct-20 N N Yes8 14-Oct-20 N N Yes9 14-Oct-20 N N Yes10 14-Oct-20 N N Yes11 14-Oct-20 N N Yes12 14-Oct-20 N N Yes13 14-Oct-20 N N Yes14 14-Oct-20 N N Yes15 14-Oct-20 N N Yes16 14-Oct-20 N N Yes17 14-Oct-20 N N Yes18 14-Oct-20 N N Yes19 14-Oct-20 N N Yes20 14-Oct-20 N N Yes21 14-Oct-20 N N Yes22 14-Oct-20 N N Yes23 14-Oct-20 N N Yes24 14-Oct-20 N N Yes25 14-Oct-20 N N Yes26 14-Oct-20 N N Yes27 14-Oct-20 N N Yes28 14-Oct-20 N N Yes29 14-Oct-20 N N Yes30 14-Oct-20 N N Yes31 14-Oct-20 N N Yes32 14-Oct-20 N N Yes33 14-Oct-20 N N Yes34 14-Oct-20 N N Yes35 14-Oct-20 N N Yes36 14-Oct-20 N N Yes37 14-Oct-20 N N Yes38 14-Oct-20 N N Yes39 14-Oct-20 Y N No40 14-Oct-20 N N Yes41 14-Oct-20 N N Yes42 14-Oct-20 N N Yes43 14-Oct-20 N N Yes44 14-Oct-20 N N Yes45 14-Oct-20 N N Yes46 14-Oct-20 N N Yes47 14-Oct-20 N N Yes
XVIII
48 14-Oct-20 N N Yes49 14-Oct-20 N N Yes50 14-Oct-20 N N Yes51 14-Oct-20 N N Yes52 14-Oct-20 N N Yes53 14-Oct-20 N N Yes54 14-Oct-20 N N Yes55 14-Oct-20 N N Yes56 14-Oct-20 N N Yes57 14-Oct-20 N N Yes58 14-Oct-20 N N Yes59 14-Oct-20 N N Yes60 14-Oct-20 N N Yes61 14-Oct-20 N N Yes62 14-Oct-20 N N Yes63 14-Oct-20 N N Yes64 14-Oct-20 N N Yes65 14-Oct-20 N N Yes66 14-Oct-20 N N Yes67 14-Oct-20 N N Yes68 14-Oct-20 N N Yes69 14-Oct-20 N N Yes70 14-Oct-20 N N Yes71 14-Oct-20 N N Yes72 14-Oct-20 N N Yes73 14-Oct-20 N N Yes74 14-Oct-20 N N Yes75 14-Oct-20 N N Yes76 14-Oct-20 N N Yes77 14-Oct-20 N N Yes78 15-Oct-20 N N Yes79 15-Oct-20 N N Yes80 15-Oct-20 N N Yes81 15-Oct-20 N N Yes82 15-Oct-20 N N Yes83 15-Oct-20 N N Yes84 15-Oct-20 N N Yes85 15-Oct-20 N N Yes86 15-Oct-20 N N Yes87 15-Oct-20 N N Yes88 15-Oct-20 N N Yes89 15-Oct-20 N N Yes
XIX
90 15-Oct-20 N N Yes91 15-Oct-20 N N Yes92 15-Oct-20 N N Yes93 15-Oct-20 N N Yes94 15-Oct-20 N N Yes95 15-Oct-20 N N Yes96 15-Oct-20 N N Yes97 15-Oct-20 N N Yes98 15-Oct-20 N N Yes99 15-Oct-20 N N Yes100 15-Oct-20 N N Yes101 15-Oct-20 N N Yes102 15-Oct-20 N N Yes103 15-Oct-20 N N Yes104 15-Oct-20 N N Yes
Note: N=Negative, P=Positive.
Results of positive samples fornasopharyngeal or throat swabs:
Sample Data of testing MedomicsAg test result RT-PCR result Coincidence
1 8-Oct-20 P P Yes2 8-Oct-20 P P Yes3 8-Oct-20 P P Yes4 8-Oct-20 P P Yes5 8-Oct-20 P P Yes6 8-Oct-20 P P Yes7 8-Oct-20 P P Yes8 8-Oct-20 P P Yes9 8-Oct-20 P P Yes10 8-Oct-20 P P Yes11 8-Oct-20 P P Yes12 8-Oct-20 P P Yes13 8-Oct-20 P P Yes14 8-Oct-20 P P Yes15 8-Oct-20 P P Yes16 8-Oct-20 P P Yes17 8-Oct-20 P P Yes18 8-Oct-20 P P Yes19 8-Oct-20 P P Yes20 8-Oct-20 P P Yes21 8-Oct-20 P P Yes22 8-Oct-20 P P Yes
XX
23 8-Oct-20 P P Yes24 8-Oct-20 P P Yes25 8-Oct-20 P P Yes26 8-Oct-20 P P Yes27 8-Oct-20 P P Yes28 8-Oct-20 P P Yes29 8-Oct-20 P P Yes30 8-Oct-20 P P Yes31 8-Oct-20 P P Yes32 8-Oct-20 P P Yes33 8-Oct-20 P P Yes34 8-Oct-20 P P Yes35 8-Oct-20 P P Yes36 8-Oct-20 P P Yes37 8-Oct-20 P P Yes38 8-Oct-20 P P Yes39 8-Oct-20 P P Yes40 8-Oct-20 P P Yes41 8-Oct-20 P P Yes42 8-Oct-20 P P Yes43 8-Oct-20 P P Yes44 8-Oct-20 P P Yes45 8-Oct-20 P P Yes46 8-Oct-20 P P Yes47 8-Oct-20 P P Yes48 8-Oct-20 P P Yes49 8-Oct-20 P P Yes50 8-Oct-20 P P Yes51 9-Oct-20 P P Yes52 9-Oct-20 P P Yes53 9-Oct-20 P P Yes54 9-Oct-20 P P Yes55 9-Oct-20 P P Yes56 9-Oct-20 P P Yes57 9-Oct-20 P P Yes58 9-Oct-20 P P Yes59 9-Oct-20 P P Yes60 9-Oct-20 P P Yes61 9-Oct-20 P P Yes62 9-Oct-20 P P Yes63 9-Oct-20 P P Yes64 9-Oct-20 P P Yes
XXI
65 9-Oct-20 P P Yes66 9-Oct-20 P P Yes67 9-Oct-20 P P Yes68 9-Oct-20 P P Yes69 9-Oct-20 P P Yes70 9-Oct-20 P P Yes71 9-Oct-20 P P Yes72 9-Oct-20 P P Yes73 9-Oct-20 P P Yes74 9-Oct-20 P P Yes75 9-Oct-20 P P Yes76 9-Oct-20 P P Yes77 9-Oct-20 P P Yes78 9-Oct-20 P P Yes79 9-Oct-20 P P Yes80 9-Oct-20 P P Yes81 9-Oct-20 P P Yes82 9-Oct-20 P P Yes83 9-Oct-20 P P Yes84 9-Oct-20 P P Yes85 9-Oct-20 P P Yes86 9-Oct-20 P P Yes87 9-Oct-20 P P Yes88 9-Oct-20 P P Yes89 9-Oct-20 P P Yes90 9-Oct-20 P P Yes91 9-Oct-20 P P Yes92 9-Oct-20 P P Yes93 9-Oct-20 P P Yes94 9-Oct-20 P P Yes95 9-Oct-20 P P Yes96 10-Oct-20 P P Yes97 10-Oct-20 P P Yes98 10-Oct-20 N P No99 10-Oct-20 P P Yes100 10-Oct-20 P P Yes101 10-Oct-20 P P Yes102 10-Oct-20 P P Yes103 10-Oct-20 P P Yes104 10-Oct-20 P P Yes105 10-Oct-20 P P Yes106 10-Oct-20 P P Yes
XXII
107 10-Oct-20 P P Yes108 10-Oct-20 P P Yes109 10-Oct-20 P P Yes110 10-Oct-20 P P Yes111 10-Oct-20 P P Yes112 10-Oct-20 P P Yes113 10-Oct-20 P P Yes114 10-Oct-20 P P Yes115 10-Oct-20 P P Yes116 10-Oct-20 P P Yes117 10-Oct-20 P P Yes118 10-Oct-20 P P Yes119 10-Oct-20 P P Yes120 10-Oct-20 P P Yes121 10-Oct-20 P P Yes122 10-Oct-20 P P Yes123 10-Oct-20 P P Yes124 10-Oct-20 P P Yes125 10-Oct-20 P P Yes126 10-Oct-20 P P Yes127 10-Oct-20 N P No128 10-Oct-20 P P Yes129 10-Oct-20 P P Yes130 10-Oct-20 P P Yes131 10-Oct-20 P P Yes132 10-Oct-20 P P Yes133 10-Oct-20 P P Yes134 11-Oct-20 P P Yes135 11-Oct-20 P P Yes136 11-Oct-20 P P Yes137 11-Oct-20 P P Yes138 11-Oct-20 P P Yes139 11-Oct-20 P P Yes140 11-Oct-20 P P Yes141 11-Oct-20 P P Yes142 11-Oct-20 P P Yes143 11-Oct-20 P P Yes144 11-Oct-20 P P Yes145 11-Oct-20 P P Yes146 11-Oct-20 P P Yes147 11-Oct-20 P P Yes148 11-Oct-20 P P Yes
XXIII
149 11-Oct-20 P P Yes150 11-Oct-20 P P Yes151 11-Oct-20 P P Yes152 11-Oct-20 P P Yes153 11-Oct-20 P P Yes154 11-Oct-20 P P Yes155 11-Oct-20 P P Yes156 11-Oct-20 P P Yes157 11-Oct-20 P P Yes158 11-Oct-20 P P Yes159 11-Oct-20 P P Yes160 11-Oct-20 P P Yes161 11-Oct-20 P P Yes162 11-Oct-20 P P Yes163 11-Oct-20 P P Yes164 11-Oct-20 P P Yes165 11-Oct-20 P P Yes166 11-Oct-20 P P Yes167 11-Oct-20 P P Yes168 11-Oct-20 P P Yes169 11-Oct-20 P P Yes170 11-Oct-20 P P Yes171 11-Oct-20 P P Yes172 11-Oct-20 N P No173 11-Oct-20 P P Yes174 11-Oct-20 P P Yes175 12-Oct-20 P P Yes176 12-Oct-20 P P Yes177 12-Oct-20 P P Yes178 12-Oct-20 N P No179 12-Oct-20 P P Yes180 12-Oct-20 P P Yes181 12-Oct-20 P P Yes182 12-Oct-20 P P Yes183 12-Oct-20 P P Yes184 12-Oct-20 P P Yes185 12-Oct-20 P P Yes186 12-Oct-20 P P Yes187 12-Oct-20 P P Yes188 12-Oct-20 P P Yes189 12-Oct-20 P P Yes190 12-Oct-20 P P Yes
XXIV
191 12-Oct-20 P P Yes192 12-Oct-20 P P Yes193 12-Oct-20 P P Yes194 12-Oct-20 P P Yes195 12-Oct-20 P P Yes196 12-Oct-20 P P Yes197 12-Oct-20 P P Yes198 12-Oct-20 P P Yes199 12-Oct-20 P P Yes200 12-Oct-20 P P Yes201 13-Oct-20 P P Yes202 13-Oct-20 P P Yes203 13-Oct-20 P P Yes204 13-Oct-20 P P Yes205 13-Oct-20 P P Yes206 13-Oct-20 P P Yes207 13-Oct-20 N P No208 13-Oct-20 P P Yes209 13-Oct-20 P P Yes210 13-Oct-20 P P Yes211 13-Oct-20 P P Yes212 13-Oct-20 P P Yes213 13-Oct-20 P P Yes214 13-Oct-20 P P Yes215 13-Oct-20 P P Yes216 13-Oct-20 P P Yes217 13-Oct-20 P P Yes218 13-Oct-20 P P Yes219 13-Oct-20 P P Yes220 13-Oct-20 P P Yes
Results of positive samples for anterior nasal swabs :
Sample Data of testing MedomicsAg test result RT-PCR result Coincidence
1 14-Oct-20 P P Yes2 14-Oct-20 P P Yes3 14-Oct-20 P P Yes4 14-Oct-20 P P Yes5 14-Oct-20 P P Yes6 14-Oct-20 P P Yes7 14-Oct-20 P P Yes8 14-Oct-20 P P Yes
XXV
9 14-Oct-20 P P Yes10 14-Oct-20 P P Yes11 14-Oct-20 P P Yes12 14-Oct-20 P P Yes13 14-Oct-20 P P Yes14 14-Oct-20 P P Yes15 14-Oct-20 P P Yes16 14-Oct-20 P P Yes17 14-Oct-20 P P Yes18 14-Oct-20 P P Yes19 14-Oct-20 P P Yes20 14-Oct-20 P P Yes21 14-Oct-20 P P Yes22 14-Oct-20 P P Yes23 14-Oct-20 P P Yes24 14-Oct-20 P P Yes25 14-Oct-20 P P Yes26 14-Oct-20 P P Yes27 14-Oct-20 P P Yes28 14-Oct-20 P P Yes29 14-Oct-20 P P Yes30 14-Oct-20 P P Yes31 14-Oct-20 P P Yes32 14-Oct-20 N P No33 14-Oct-20 P P Yes34 14-Oct-20 P P Yes35 14-Oct-20 P P Yes36 14-Oct-20 P P Yes37 14-Oct-20 P P Yes38 14-Oct-20 P P Yes39 14-Oct-20 P P Yes40 14-Oct-20 P P Yes41 14-Oct-20 P P Yes42 14-Oct-20 P P Yes43 14-Oct-20 P P Yes44 14-Oct-20 P P Yes45 14-Oct-20 P P Yes46 14-Oct-20 P P Yes47 14-Oct-20 P P Yes48 14-Oct-20 P P Yes49 14-Oct-20 P P Yes50 14-Oct-20 P P Yes
XXVI
51 14-Oct-20 P P Yes52 14-Oct-20 P P Yes53 14-Oct-20 P P Yes54 14-Oct-20 P P Yes55 14-Oct-20 P P Yes56 14-Oct-20 P P Yes57 14-Oct-20 P P Yes58 15-Oct-20 P P Yes59 15-Oct-20 P P Yes60 15-Oct-20 P P Yes61 15-Oct-20 P P Yes62 15-Oct-20 P P Yes63 15-Oct-20 P P Yes64 15-Oct-20 P P Yes65 15-Oct-20 P P Yes66 15-Oct-20 P P Yes67 15-Oct-20 N P No68 15-Oct-20 P P Yes69 15-Oct-20 P P Yes70 15-Oct-20 P P Yes71 15-Oct-20 P P Yes72 15-Oct-20 P P Yes73 15-Oct-20 P P Yes74 15-Oct-20 P P Yes75 15-Oct-20 P P Yes76 15-Oct-20 P P Yes77 15-Oct-20 P P Yes78 15-Oct-20 P P Yes79 15-Oct-20 P P Yes80 15-Oct-20 P P Yes81 15-Oct-20 P P Yes82 15-Oct-20 P P Yes83 15-Oct-20 P P Yes84 15-Oct-20 P P Yes85 15-Oct-20 P P Yes86 15-Oct-20 P P Yes87 15-Oct-20 P P Yes88 15-Oct-20 P P Yes89 15-Oct-20 P P Yes90 15-Oct-20 P P Yes91 15-Oct-20 P P Yes92 15-Oct-20 P P Yes
XXVII
93 15-Oct-20 P P Yes94 15-Oct-20 P P Yes95 15-Oct-20 N P No96 15-Oct-20 P P Yes97 15-Oct-20 N P No98 15-Oct-20 P P Yes99 15-Oct-20 P P Yes100 15-Oct-20 P P Yes101 15-Oct-20 P P Yes102 15-Oct-20 P P Yes103 15-Oct-20 P P Yes104 15-Oct-20 P P Yes105 15-Oct-20 P P Yes106 15-Oct-20 P P Yes107 15-Oct-20 P P Yes108 15-Oct-20 N P No109 15-Oct-20 P P Yes110 15-Oct-20 P P Yes111 15-Oct-20 P P Yes112 15-Oct-20 P P Yes
Note: N=Negative, P=Positive.
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