VITEK MS Collaborative Study Outline - eBook

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T = 62   1  1  1  T = 119   1  1  1  T = 242  1  1  1  T = 410  1  1  3  3  1  1  1  *Indicates number of 12‐strain experiments performed A: kits free from thermal shock sequence, stored at 2‐8C, these kits only tested in the event of non‐ confirmity of the Assay kits B: Assay kits stored at 2‐8C after the thermal shock sequence C: Assay kits turned over during the thermal shock sequence and during storage at 2‐8C D: Assay kits stored at 2‐8C up to T=126 days followed by opening test D1: opening of tube for 1 hr on 1 day, followed by storage at 2‐8C until biological tests T = 370  1  1  3  3  1  1  1  T = 126   1  1  6  6  1  1  1 

days  A: Controls  B  C  D1, D3, D5  E1, E3, E5  F  A  A  T = 0   1*  1  1 

Lot 3 ‐ 

I231/10 

Lot 2 ‐ 

I230/10 

T = 21   1  1 

Lot 1 ‐ I229/10 

Time point, 

E3: opening of tube for 1 hr on 3 days, storage at room temp between openings and until biological tests E5: opening of tube for 1 hr on 5 days, storage at room temp between openings and until biological tests F: Assay kits stored at 2‐8C after thermal shock sequence up to T=119 days followed by storage at room  temp for 8 days without opening tube

D3: opening of tube for 1 hr on 3 days, storage at 2‐8C between openings and until biological tests D5: opening of tube for 1 hr on 5 days, storage at 2‐8C between openings and until biological tests E1: opening of tube for 1 hr on 1 day, followed by storage at room temp until biological tests

Table 21. Experiments Performed at Each Time‐point During the Lot to Lot/Stability Study