CDSimple™ FT3, FT4, TSH Chemiluminescent ELISA Kit
Regulatory status: For research use only, not for use in diagnostic procedures.
COA
Sample
serum and plasma
Species Reactivity
Human
Intended Use
The Quantitative Determination of Free Thyroxine; Free Triiodothyronine; Thyrotropin Concentration for a comprehensive thyroid status of a Human Serum or Plasma sample by a Microplate Enzyme Immunoassay, Colorimetric.
Storage
Note 1: TSH concentrations were calibrated using a reference preparation, which was assayed against the WHO 2nd, IRP 80/558
Note 2: Do not use reagents beyond the kit expiration date.
Note 3: Avoid extended exposure to heat and light. Opened reagents are stable for sixty (60) days when stored at 2-8°C. Kit and component stability are identified on the label.
Note 4: Above reagents are for a 192 well microplate kit.
Performance Characteristics
The Free Thyroid Panel ELISA Test System was compared with reference immunometric methods. The least square regression equation and the correlation coefficient were computed for the ELISAs in comparison with the reference methods. The data obtained are displayed in Table 10-12.
Only slight amounts of bias between this method and the reference method are indicated by the closeness of the mean values. The least square regression equation and correlation coefficient indicates excellent method agreement.
Only slight amounts of bias between this method and the reference method are indicated by the closeness of the mean values. The least square regression equation and correlation coefficient indicates excellent method agreement.
Precision
The within and between assay precision of the Free Thyroid Panel were determined by analyses on three different levels of pool control sera. The number, mean values, standard deviation and coefficient of variation for each of these control sera are presented in Table 4 and Table 5 (fT4), Table 6 and Table 7 (fT3) and Table 8 and Table 9 (TSH).
Sensitivity
The fT4 procedure has a sensitivity of 0.04 ng/dl. The sensitivity was ascertained by determining the variability of the 0 ng/dl serum calibrator and using the 2σ (95% certainty) statistic to calculate the minimum dose.
The fT3 procedure has a sensitivity of 0.04 pg/ml. The sensitivity was ascertained by determining the variability of the 0 pg/ml serum calibrator and using the 2σ (95% certainty) statistic to calculate the minimum dose.
The TSH sensitivity (detection limit) was ascertained by determining the variability of the 0 μIU/ml serum calibrator and using the 2σ (95% certainty) statistic to calculate the minimum dose: For I hr incubation = 0.065 μIU/ml
General Description
Measurements of thyroid hormones (fT3, fT4 and TSH) are generally regarded as invaluable in-vitro diagnostic tests for assessing thyroid function.
The Combination Free Thyroid Panel provides the convenience of combination calibrators, universal plate and flexible reagent selection allowing technicians to perform a variety of assay designs. In this method, serum reference, patient specimen, or control is first added to a microplate well. Enzyme-fT4 (fT3) conjugate and biotinylated fT4 or fT3 antibody are added, and the reactants are mixed. In the case of TSH, the biotinylated and enzyme conjugate are added in one step. A reaction results between the enzyme conjugate, biotinylated conjugate and the native thyroid hormone (fT3, fT4 or TSH) for the antibody combining sites. Immobilization takes place through the reaction of the incorporated biotin and streptavidin coated on the well. After the completion of the required incubation period, the bound enzyme conjugate is separated from the unbound enzyme conjugate by aspiration or decantation. The activity of the enzyme present on the surface of the well is quantitated by reaction with a suitable substrate to produce color.
The employment of several serum references of known thyroid hormone concentration(s) permits construction of a graph of activity and concentration. From comparison to the dose response curve(s), an unknown specimen's activity can be correlated with hormone concentration.
Standard Curve
The data presented in Example 1-3 and Figure 1-3 are for illustration only and should not be used in lieu of calibration curve prepared with each assay.
Citations
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Antibiotic resistance and virulence of Escherichia coli strains isolated from animal rendering plant
SCIENTIFIC REPORTS
Authors: Gregova, Gabriela; Kmet, Vladimir
Processing of animal carcasses and other animal wastes in rendering plants is a significant source of antibiotic resistant microorganisms. The main goal of this study was to investigate the resistance to 18 antibacterial agents including beta -lactams, fluoroquinolones, colistin and virulence factors (iss, tsh, cvaC, iutA, papC, kps and ibeA genes) in 88 Escherichia coli strains isolated from a rendering plant over 1 year period. ESBL (Extended-spectrum beta-lactamases) and plasmid-mediated Amp were screened by interpretative reading of MIC. ESBL phenotype was detected in 20.4% of samples and high level of resistance to fluoroquinolone was found in 27.2% of strains. Cephalosporinase CTX-M1, cephamycinase CMY-2, integrase 1 and transposon 3 genes were detected by PCR. Furthermore, there were found three CMY-2 producing E. coli with O25b-ST131, resistant to the high level of enrofloxacin and containing the gene encoding the ferric aerobactin receptor (iutA). One enrofloxacin resistant E. coli strain possessed iss, ibeA, kps and papC virulence genes also with CMY-2, integrase1 and Tn3. ST131 E. coli with CMY-2 has a zoonotic potential and presents a serious health risk to humans.
Incidence and risk factors for umbilical trocar site hernia after laparoscopic TAPP repair. A single high-volume center experience
SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES
Authors: Harriott, Camila Bras; Dreifuss, Nicolas H.; Schlottmann, Francisco; Sadava, Emmanuel E.
Background Trocar site hernia (TSH) is often underestimated after minimally invasive surgery. Scarce information is available about the incidence of TSH in patients undergoing laparoscopic hernioplasty. We aimed to evaluate the incidence and risk factors of umbilical TSH after laparoscopic TAPP hernioplasty in patients with and without an associated umbilical hernia. Methods A retrospective analysis of a prospectively collected database of all patients who underwent laparoscopic inguinal TAPP repair during 2013-2018 was performed. After TAPP repair, the umbilical fascia was closed either by a figure-of-eight stitch with absorbable suture (G1) or by umbilical hernioplasty if it was present (G2). Multivariate logistic regression analysis was used to determine the TSH risk factors. Comparative evaluation regarding demographics, and operative and postoperative variables was performed. Results A total of 535 laparoscopic TAPP repairs were included. There were 359 (67.1%) patients in G1 and 176 in G2 (32.9%). Surgical site infection was higher in G2 (G1: 0.6% vs G2: 5.7%,p = 0.001). Overall TSH rate was 3.9% after a mean follow-up of 20 (12-41) months. Performing a concomitant umbilical repair significantly increased the risk of umbilical TSH (G1: 2.2% vs G2: 7.4%,p = 0.004). TSH rates in G2 were similar in patients with simple suture or mesh repairs (p = 0.88). Rectus abdominis diastasis (OR 37.8, 95% CI:8.22-174.0,p < 0.001) and inguinal recurrence (OR 13.5, 95% CI:2.04-89.5,p = 0.007) were independent risk factors for TSH. Conclusion Although trocar site hernia after laparoscopic TAPP repair has a low incidence, its risk is significantly increased in patients with a concomitant umbilical hernia repair, rectus abdominis diastasis, and/or inguinal recurrence.
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