Respiratory pathogens 33 february 2011 version 1 - Mikrogen

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2. Sensitivity � The analytical detection limit was tested by using a tenfold dilution row of plasmid DNA of known concentration (1E+09-1E+00 copies/ ml) and the FTD Resp 33 test. The linear range of quantitation is derived from the detection limit until 1E+09 copies/ml (table 9). Furthermore, it was analyzed by using diluted positive patient samples, calculated with quantitation standards containing plasmid DNA of known concentration (1E+09-1E+06 copies/ml) and the FTD Resp 33 test (table 9). Table 9: Detection limit of plasmid DNA and positive respiratory samples with plasmid DNA as quantitation standard. PPmix Pathogen FluAB_Rhino ParaEAV Cor RsEPAcmv Bo-mp-Pf1 RespBac2 KLePSa MoBoCH Fast-track Diagnostics Luxembourg S.a.r.l. Z. I. Langwies L-6131 Junglinster, Luxembourg, Tel. +352 780290 332/329 Fax: +352 780290 514 http://www.fast-trackdiagnostics.com/ positive sample plasmid Detection limit (copies/ml) Detection limit (copies/10µl PCR) Page 10 Detection limit (copies/ml) Detection limit (copies/10µl PCR) FluA 2,05E+03 2,05E+01 1,00E+02 1,00E+00 FluB 6,98E+02 6,98E+00 1,00E+03 1,00E+01 Rhino 2,78E+02 2,78E+00 1,00E+04 1,00E+02 PF2 1,68E+02 1,68E+00 1,00E+02 1,00E+00 PF3 5,04E+02 5,04E+00 1,00E+03 1,00E+01 PF4 1,12E+04 1,14E+02 1,00E+04 1,00E+02 Cor63 3,66E+01 3,66E-01 1,00E+03 1,00E+01 Cor229 1,98E+03 1,98E+01 1,00E+04 1,00E+02 Cor43 4,47E+02 4,47E+00 1,00E+02 1,00E+00 HKU 5,17E+02 5,17E+00 1,00E+03 1,00E+01 EV 2,70E+02 2,70E+00 1,00E+04 1,00E+02 PV 7,35E+03 7,35E+01 1,00E+03 1,00E+01 RSV 1,18E+04 1,18E+02 1,00E+03 1,00E+01 CMV 2,80E+02 2,80E+00 1,00E+04 1,00E+02 AV 2,17E+02 2,17E+00 1,00E+04 1,00E+02 PF1 2,37E+03 2,37E+01 1,00E+03 1,00E+01 HMPV 5,75E+02 5,75E+00 1,00E+01 1,00E-01 HboV 1,03E+03 1,03E+01 1,00E+03 1,00E+01 Mpneu 2,32E+02 2,32E+00 1,00E+02 1,00E+00 Cpneu 2,24E+02 2,24E+00 1,00E+03 1,00E+01 Spneu 5,90E+01 5,90E-01 1,00E+03 1,00E+01 HIB 6,25E+02 6,25E+00 1,00E+02 1,00E+00 Saur 3,47E+02 3,47E+00 1,00E+02 1,00E+00 Legio 6,89E+02 6,89E+00 1,00E+03 1,00E+01 Kpneu 2,46E+02 2,46E+00 1,00E+03 1,00E+01 PCP 9,56E+02 9,56E+00 1,00E+02 1,00E+00 Salm 1,96E+02 1,96E+00 1,00E+03 1,00E+01 Morax 4,39E+01 4,39E-01 1,00E+03 1,00E+01 Bord 1,35E+03 1,35E+01 1,00E+04 1,00E+02 FluC 3,02E+03 3,02E+01 1,00E+04 1,00E+02 Haeinf 3,05E+03 3,05E+01 1,00E+03 1,00E+01 March 2011
� The analytical detection limit was retested in measuring tenfold dilution series of plasmid DNA of known concentration (1E+06-1E+02 copies/ ml) and the FTD Resp 33 multiplexes. (table 10). Table 10: Detection limit of plasmid DNA in tenfold measuring. It is given the amount of positive detected rating (x/10) and the accordant detection percentage (%). neg = not detected n.t. = not tested pathogen plasmid 10 6 cop/ml plasmid 10 5 cop/ml plasmid 10 4 cop/ml plasmid 10 3 cop/ml plasmid 10 2 x/10 % x/10 % x/10 % x/10 % cop/ml x/10 % FluA n.t. n.t. 10/10 100% 10/10 100% 9/10 90% 5/10 50% FluB n.t. n.t. 10/10 100% 10/10 100% 7/10 70% neg neg Rhino 10/10 100% 10/10 100% 10/10 100% 10/10 100% n.t. n.t. Para2 n.t. n.t. 10/10 100% 10/10 100% 10/10 100% 5/10 50% Para3 10/10 100% 10/10 100% 10/10 100% 10/10 100% n.t. n.t. Para4 10/10 100% 10/10 100% neg neg n.t. n.t. n.t. n.t. Cor63 10/10 100% 10/10 100% 10/10 100% 10/10 100% n.t. n.t. Cor229 10/10 100% 10/10 100% 10/10 100% 9/10 90% n.t. n.t. Cor43 n.t. n.t. 10/10 100% 10/10 100% 10/10 100% 7/10 70% HKU1 10/10 100% 10/10 100% 10/10 100% neg neg n.t. n.t. Para1 10/10 100% 10/10 100% 10/10 100% 10/10 100% n.t. n.t. Hump n.t. n.t. n.t. n.t. 10/10 100% 10/10 100% 10/10 100% Boca 10/10 100% 10/10 100% 10/10 100% 10/10 100% n.t. n.t. Mpneu n.t. n.t. 10/10 100% 10/10 100% 10/10 100% 7/10 70% Adeno 10/10 100% 10/10 100% 10/10 100% 9/10 90% 2/10 20% RSV A/B 10/10 100% 10/10 100% 10/10 100% 5/10 50% n.t. n.t. PV 10/10 100% 2/10 20% neg neg n.t. n.t. n.t. n.t. CMV 10/10 100% 10/10 100% 10/10 100% 10/10 100% n.t. n.t. EV 10/10 100% 10/10 100% 10/10 100% 9/10 90% n.t. n.t. Spneu Hib 10/10 100% 10/10 100% 10/10 100% 6/10 60% n.t. Saur 10/10 100% 10/10 100% 10/10 100% 3/10 30% Fast-track Diagnostics Luxembourg S.a.r.l. 10/10 100% 10/10 100% 10/10 100% 4/10 40% Cpneu 10/10 100% 10/10 100% 10/10 100% 5/10 50% Legio 10/10 100% 10/10 100% 10/10 100% 4/10 40% Kpneu 10/10 100% 10/10 100% 10/10 100% 1/10 10% n.t. PCP 10/10 100% 10/10 100% 9/10 90% 2/10 20% Salm 10/10 100% 10/10 100% 9/10 90% 3/10 30% Morax n.t. n.t. 10/10 100% 10/10 100% 10/10 100% 3/10 30% Bord 10/10 100% 10/10 100% 10/10 100% 9/10 90% n.t. n.t. FluC 10/10 100% 10/10 100% 10/10 100% 7/10 70% n.t. n.t. Haeinf 10/10 100% 10/10 100% 10/10 100% 9/10 90% n.t. n.t. � The endpoint detection limit of the multiplex PCR`s were compared to the singleplex PCR`s. Fivefold and tenfold diluted positive patient material was tested by singleplex and multiplex. All multiplex PCR`s show pretty similar detection limits than the singleplexes (table 11) Z. I. Langwies L-6131 Junglinster, Luxembourg, Tel. +352 780290 332/329 Fax: +352 780290 514 http://www.fast-trackdiagnostics.com/ Page 11 March 2011
Page 1 and 2: Validation FTD Respiratory pathogen
Page 3 and 4: 1. Specificity The BLAST (www.ncbi.
Page 5 and 6: Table 2: Evaluation of the specific
Page 7 and 8: Table 3: “instand Ringversuch Flu
Page 9: Table 7: Evaluation of the salm pan
Page 13 and 14: MoBoCH PPmix Sample Morax Sample Bo

Respiratory pathogens 33 february 2011 version 1 - Mikrogen

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