Review Team (February 2016)

)LJXUH 0ROHFXODU VWUXFWXUH RI DPLQR DFLGV

Limit of detection (LOD) ²7KH PLQLPXP FRQFHQWUDWLRQ RU PDVV RI DQDO\WH WKDW FDQ EH GHWHFWHG LQ D JLYHQ PDWUL[ ZLWK QR JUHDWHU WKDQ IDOVH SRVLWLYH ULVN DQG IDOVH QHJDWLYH ULVN Limit of quantitation (LOQ) ²7KH PLQLPXP FRQFHQWUDWLRQ RU PDVV RI DQDO\WH LQ D JLYHQ PDWUL[ WKDW FDQ EH UHSRUWHG DV D TXDQWLWDWLYH UHVXOW Proteinogenic L-Į-amino acids ²$PLQR DFLGV WKDW DUH SUHFXUVRUV WR SURWHLQV See )LJXUH IRU PROHFXODU VWUXFWXUHV

Repeatability ²9DULDWLRQ DULVLQJ ZKHQ DOO HIIRUWV DUH PDGH WR NHHS FRQGLWLRQV FRQVWDQW E\ XVLQJ WKH VDPH LQVWUXPHQW DQG RSHUDWRU DQG UHSHDWLQJ GXULQJ D VKRUW WLPH SHULRG ([SUHVVHG DV WKH UHSHDWDELOLW\ VWDQGDUG GHYLDWLRQ 6' U RU UHSHDWDELOLW\ UHODWLYH VWDQGDUG GHYLDWLRQ 56' U Reproducibility ²7KH VWDQGDUG GHYLDWLRQ RU UHODWLYH VWDQGDUG GHYLDWLRQ FDOFXODWHG IURP DPRQJ ODERUDWRU\ GDWD ([SUHVVHG DV WKH UHSURGXFLELOLW\ VWDQGDUG GHYLDWLRQ 6' 5 RU UHSURGXFLELOLW\ UHODWLYH VWDQGDUG GHYLDWLRQ 56' 5 Recovery ²7KH IUDFWLRQ RU SHUFHQWDJH RI VSLNHG DQDO\WH WKDW LV UHFRYHUHG ZKHQ WKH WHVW VDPSOH LV DQDO\]HG XVLQJ WKH HQWLUH PHWKRG Taurine ² $PLQRHWKDQHVXOIRQLF DFLG 7DXULQH LV VRPHWLPHV FDOOHG DQ DPLQR DFLG EXW LW GRHV QRW FRQWDLQ D FDUER[\O JURXS QHFHVVDU\ WR EH FODVVL¿HG DV DQ DPLQR DFLG ,W LV LQ IDFW DQ DFLG FRQWDLQLQJ DQ DPLQR JURXS See )LJXUH IRU WKH PROHFXODU VWUXFWXUH 4 Method Performance Requirements See 7DEOH

)LJXUH 0ROHFXODU VWUXFWXUH RI WDXULQH

‹ $2$& ,17(51$7,21$/