イムノクロマト法を用いたテトロドトキシン（TTX）検査キットの有効性について検討した。マトリックス非存在下では，0.0125-0.2マウス単位 (MU)/mLの濃度範囲で，テストプレートに形成されるCラインとTラインの強度比（T/C）とTTX濃度の対数の間に強い負の相関が認められ，終濃度約0.06 MU/mLを検出限界として目視によりTTXの有無を判定することができた。一方，マトリックスが存在する場合，その影響を前処理で低減しても偽陽性が出やすかったが，偽陰性は全く認められなかった。

BACKGROUND As there is no specific treatment for dengue, early detection and access to proper treatment may lower dengue fatality. Therefore, having new techniques for the early detection of dengue fever, such as the use of dengue test kit, is vitally important. The aims of the study were: 1) identify factors associated with acceptance of a home self-test kit for dengue fever if the dengue test...

We developed a new kit for detecting alpha-fetoprotein (AFP) in leaked amniotic fluid (Eur J Obstet Gynecol Reprod Biol 1995;58:67-72). Later, we developed an improved AFP kit utilizing the same AFP monoclonal antibody. We compared this improved AFP test with the nitrazine test for 137 patients. The nitrazine test correctly diagnosed 62.1% of the cases, but the improved AFP kit diagnosed 98.0% ...

Thyroxine, the principal thyroid hormone, circulates in blood almost completely bound to carrier proteins. The main carrier is thyroxine-binding globulin (TBG). However, only the free (unbound) portion of thyroxine is responsible for the biological action. Further, the concentrations of the carrier proteins are altered in many clinical conditions, such as pregnancy. In normal thyroid function a...

II. General Guidance for Evaluation of Pathogen Test Kit Performance 1. Purpose, Scope and Audience 2. General Considerations 3. Inoculum Number of strains Strain selection (Table 1) Preparation of inoculum Inoculation of matrix 4. Matrix Choice of matrix (Tables 2a, Table 2b) Decision Criteria Illustrating When New Validation Studies Should be Conducted for an Existing Method Characterization ...