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  • Summary Clinical Study Report - Biocredit - COVID19 Ag

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    Juan Carlos Reygada Salgado
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    1) A clinical study was conducted to evaluate the BIOCREDIT COVID-19 Ag rapid antigen test using nasopharyngeal samples from symptomatic patients confirmed to have COVID-19 by RT-PCR testing. 2) Samples were collected from two hospitals in Seoul, South Korea, including 15 positive and 2 negative samples based on RT-PCR results. 3) The BIOCREDIT COVID-19 Ag test identified 12 of the 15 PCR-positive samples as positive, and both PCR-negative samples as negative, demonstrating 80% sensitivity and 100% specificity compared to RT-PCR.

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    1) A clinical study was conducted to evaluate the BIOCREDIT COVID-19 Ag rapid antigen test using nasopharyngeal samples from symptomatic patients confirmed to have COVID-19 by RT-PCR testing. 2) Samples were collected from two hospitals in Seoul, South Korea, including 15 positive and 2 negative samples based on RT-PCR results. 3) The BIOCREDIT COVID-19 Ag test identified 12 of the 15 PCR-positive samples as positive, and both PCR-negative samples as negative, demonstrating 80% sensitivity and 100% specificity compared to RT-PCR.

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    23 views4 pages

    Summary Clinical Study Report - Biocredit - COVID19 Ag

    Uploaded by

    Juan Carlos Reygada Salgado
    1) A clinical study was conducted to evaluate the BIOCREDIT COVID-19 Ag rapid antigen test using nasopharyngeal samples from symptomatic patients confirmed to have COVID-19 by RT-PCR testing. 2) Samples were collected from two hospitals in Seoul, South Korea, including 15 positive and 2 negative samples based on RT-PCR results. 3) The BIOCREDIT COVID-19 Ag test identified 12 of the 15 PCR-positive samples as positive, and both PCR-negative samples as negative, demonstrating 80% sensitivity and 100% specificity compared to RT-PCR.

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    © All Rights Reserved
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    of 4

    RapiGEN INC.

    16, LS-ro 91 beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 14119, Republic of Korea

    Tel: +82-31-427-4677 Fax: +82-31-427-4678 Website: www.rapigen-inc.com

    Summary clinical study report

    Study title:

    Retrospective clinical trial to evaluate clinical performance of BIOCREDIT


    COVID-19 Ag using clinical specimens in human nasopharynx obtained from
    symptomatic patients confirmed by RT-PCR.

    Product name: BIOCREDIT COVID-19 Ag

    Clinical trial centers: 1. Seoul Asan Hospital

    2. Eunpyung St. Mary’s Hospital

    RapiGEN INC.

    RQP-702-F09(‘18.04.24) REV.02 RapiGEN


    RapiGEN INC.
    16, LS-ro 91 beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 14119, Republic of Korea

    Tel: +82-31-427-4677 Fax: +82-31-427-4678 Website: www.rapigen-inc.com

    1. Type of specimen

    Type of Number of Number of Comments


    Clinical Centers
    Specimen specimens patients

    UTM
    Catholic University of Korea, Positive: 3 RT-PCR
    (nasopharyngeal Patient: 3
    Eunpyung St. Mary's Hospital Negative: 2 confirmed
    collection)
    for positive
    Positive: 12 Patient: 4
    Seoul Asan Hospital UTM specimens
    Negative: 0 Patient: 0

    2. Trial results
    1) Positive specimens
    Catholic University of Korea, BIOCREDIT
    PCR data
    Eunpyung St. Mary’s Hospital COVID-19 Ag
    Date of Date of
    Patient Specimen Day after
    Symptom specimen CT value Results Ag Results
    No. type onset
    onset collection

    1 No data No data UTM* No data E:16.76, R:17.20 Pos. ± Pos.

    Positive
    2 No data No data UTM No data E:15.36, R:15.58 Pos. + Pos.
    Sample
    3ea

    3 No data No data UTM No data E:18.18, R:18.55 Pos. + Pos.

    4 No data No data UTM No data >40 Neg. - Neg.

    Negative
    Sample
    2ea

    5 No data No data UTM No data >40 Neg. - Neg.

    RQP-702-F09(‘18.04.24) REV.02 RapiGEN


    RapiGEN INC.
    16, LS-ro 91 beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 14119, Republic of Korea

    Tel: +82-31-427-4677 Fax: +82-31-427-4678 Website: www.rapigen-inc.com

    BIOCREDIT
    Seoul Asan Hospital PCR data
    COVID-19 Ag
    Date of Date of
    Patient Specimen Day after
    symptom Specimen CT value Results Ag Results
    No. type onset
    onset collection

    27 Feb. E:22.61, R:24.88


    No data UTM 1 Pos. w+ Pos.
    2020 N:25.18

    29 Feb. E:32.5, R:33.09


    A001 No data UTM 3 Pos. w+ Pos.
    2020 N:35.24

    02 Mar. E:31.95, R:34.49


    No data UTM 5 Pos. - Neg.
    2020 N:35.95

    08 Mar. E:19.94, R:21.93


    No data UTM 1 Pos. w+ Pos.
    2020 N:35.95

    10 Mar. E:22.57, R:24.53


    A002 No data UTM 3 Pos. w+ Pos.
    2020 N:26.79

    Positive
    Sample 14 Mar. E:32.6, R:34.83
    No data UTM 7 Pos. - Neg.
    12ea 2020 N:36.59

    13 Mar. E:21.07, R:22.96


    No data UTM 1 Pos. - Neg.
    2020 N:24.29

    16 Mar. E:9.63, R:12.81


    A003 No data UTM 4 Pos. + Pos.
    2020 N:13.51

    17 Mar. E:18.46, R:19.95


    No data UTM 5 Pos. w+ Pos.
    2020 N:23.36

    28 Mar. E:20.35, R:21.93


    No data UTM 1 Pos. w+ Pos.
    2020 N:23.99

    30 Mar. E:27.95, R:29.81


    A004 No data UTM 3 Pos. w+ Pos.
    2020 N:30.99

    03 Apr. E:29.99, R:31.69


    No data UTM 7 Pos w+ Pos.
    2020 N:32.26

    RQP-702-F09(‘18.04.24) REV.02 RapiGEN


    RapiGEN INC.
    16, LS-ro 91 beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 14119, Republic of Korea

    Tel: +82-31-427-4677 Fax: +82-31-427-4678 Website: www.rapigen-inc.com

    3. Conclusion
    1) 15 positive specimens which were confirmed by RT-PCR are tested with BIOCREDIT
    COVID-19 Ag kit, and 12 specimens are identified as positive as well.

    Relative Sensitivity (%) = 100 x (No. of specimens with positive results /


    No. of positive specimens tested by RT-PCR)

    2) 2 negative specimens which were confirmed by RT-PCR are tested with BIOCREDIT
    COVID-19 Ag kit, and all the specimens are identified as negative.

    Relative Specificity (%) = 100 x (No. of specimens with negative results /


    No. of negative specimens tested by RT-PCR)

    BIOCREDIT RT-PCT
    Sensitivity Specificity
    COVID-19 Ag
    Positive Negative (%) (%)

    Positive 12 0
    Ag 80 100
    Negative 3 2
    (12/15) (2/2)
    Total 15 2

    3) UTM specimen test has a specimen dilution effect comparing to direct nasopharyngeal
    swab collection method. Consequently, sensitivity becomes lower than original swab
    specimen when BIOCREDIT COVID-19 Ag is tested using UTM specimen.

    [Comment]

    (A001, 08Mar2020) PCR CT Value (E:31.95, R:34.49, N:35.95) & (A002, 14Mar2020) PCR CT Value (E:32.60, R:34.83, N:36.59)

    In these two cases, PCR CT Value show near offset(decision) value (34~36). According as the offset value setting, this result
    can be decided by "NEGATIVE" also.

    Including these two cases, Sensitivity is 12/15, 80%. Except them (as invalid result), 12/13, 92.3%.

    RQP-702-F09(‘18.04.24) REV.02 RapiGEN

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