Laboratory and Clinical Evaluation of a Feia Method for Canine Serum Progesterone Assay

Rota, Alessandra; Vannozzi, Iacopo; Marianelli, S; Gavazza, Alessandra; Lubas, George

doi:10.1111/rda.12647

Cited by 13 publications

(12 citation statements)

References 32 publications

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“…To establish validity, the AIA-360 P4 results were compared to liquid chromatography and mass spectrometry (LC-MS), which "has been proposed as a gold standard" for steroid hormone measurements but has yet to be validated for quantitative canine P4 assays (36)(37)(38)(39)(40). While there was strong a significant correlation (r = 0.979; P < 0.001) between P4 measurements obtained on the AIA-360 FEIA with LC-MS, FEIA values were significantly higher than the LC-MS comparison (36). A high correlation (r 2 = 0.978) has been illustrated between the AIA-360 analyzer and the CLIA standard (41).…”

Section: Introductionmentioning

confidence: 99%

Comparison of a Point-of-Care Analyzer With a Chemiluminescent Immunoassay for Serum Progesterone Measurement in Breeding Management of the Bitch

et al. 2021

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Accurate serum progesterone measurements for timing bitches during breeding management is critical for reproductive practice, especially as artificial insemination has become routine to facilitate breeding of animals that are geographically or temporally separated. To measure serum progesterone, chemiluminescent immunoassay (CLIA) has replaced radioimmunoassay as the current standard in the bitch due to its high correlation and increased practicality. In January 2019, a colorimetric point-of-care (POC) immunoassay for quantitative in-clinic canine serum progesterone measurements in <30 min was released. This study provides an independent comparison of the POC (Catalyst One, IDEXX) to the current industry standard, CLIA (Immulite-2000, Siemens). To assess inter-assay imprecision of POC and agreement of the POC and CLIA results, 100 canine serum samples were analyzed on three analyzers (POC-1, POC-2, and CLIA), of which, 74 (POC-1) and 75 (POC-2) results were within POCs' reportable range of 0.2–20 ng/mL and included in the study. To assess intra-assay imprecision, pooled canine serum samples at low (L1), intermediate (L2), and high (L3) progesterone concentrations were analyzed ten times each on POC-1 and CLIA. Relative to CLIA, POC values showed good correlation (POC-1, r2 = 0.9366; POC-2, r2 = 0.9438, P < 0.0001) and significant positive proportional bias at values >2 ng/mL. The POC inter-assay coefficients of variation (CVs) were 13.2% (0.2–2.9 ng/mL, 0.6–9.2 nmol/L, L1), 10.0% (3.0–9.9 ng/mL, 9.5–31.5 nmol/L, L2), 7.1% (10.0–20.0 ng/mL, 31.8–63.6 nmol/L, L3), and 11.2% (all samples). The intra-assay CVs for POC (L1, 15.3%; L2, 7.0%; L3, 4.7%) were higher than those for CLIA (L1, 5.89%; L2, 4.89%; L3, 3.44%). Based on the more rapid increase in serial serum progesterone concentrations in ovulating bitches and the greater imprecision of the POC, the clinical interpretations of serum progesterone measurements as they relate to canine breeding management should be made with caution.

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Section: Introductionmentioning

confidence: 99%

Comparison of a Point-of-Care Analyzer With a Chemiluminescent Immunoassay for Serum Progesterone Measurement in Breeding Management of the Bitch

et al. 2021

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“…This is in line with CVs reported in other studies. 1,12,15 We found the highest CV for those concentrations that were very close to the lower limit of detection of the kit, set by the manufacturer at 0.1 ng/mL.…”

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confidence: 59%

“…2 These differences may be the result of a change of the monoclonal antibody in the CLIA, together with the change from a 2-cycle to a 1-cycle competitive immunoassay in the CLIA method. The first-generation kit of the FEIA method was validated against liquid chromatography–tandem mass spectrometry in the canine species in 2016 15 ; however, since then, the manufacturer has modified and improved the P4 kit, with the release of a third-generation kit in 2016. We compared this third-generation human progesterone kit (ST AIA-PACK PROG-III, AIA-360 analyzer; Tosoh Bioscience) with the CLIA (Human progesterone assay, Immulite 1000; Siemens), which had been validated for bitches 10 and was in routine use in our laboratory before acquiring the new instrument.…”

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confidence: 99%

Analytical and clinical performance of a fluorescence enzyme immunoassay for progesterone and determination of ovulation day in bitches

Milani¹,

Boscato²,

Gabai³

et al. 2022

J VET Diagn Invest

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We evaluated the performance of a third-generation fluorescence enzyme immunoassay kit (FEIA; Tosoh Bioscience) for progesterone (P4) measurement in canine serum to identify the day of luteinizing hormone (LH) peak and ovulation in bitches. We conducted P4 assays on 54 serum samples using a FEIA and a chemiluminescence immunoassay (CLIA; Siemens). For the FEIA kit, the linearity test, recovery test, inter- and intra-assay CVs, and total error observed (TEo) were calculated. Serum samples from 28 bitches were used to evaluate the association of P4 concentration with the day of LH peak and the day of ovulation based on P4 thresholds (P4 ≥ 2 ng/mL, and doubling at 4–8 ng/mL in the following 48 h), and with pregnancy length. Linearity was 75–97% and 86–94% for high (37.0 ng/mL) and medium (3.8 ng/mL) pool serum samples, respectively. Recovery was 86.4–119%. Intra-assay CVs were 2.6%, 3.3%, and 5.2% for low (0.23 ng/mL), medium (6.24 ng/mL), and high (38.3 ng/mL) pool concentrations. Inter-assay CVs were 2.22% and 2.53% for P4 concentrations of 2.70 ng/mL and 8.2 ng/mL, respectively. TEo was 8.72% and 22.7% for P4 concentrations of 2 and 8 ng/mL, respectively. The mean pregnancy length from the day of LH peak and ovulation were 64.6 ± 1.7 and 63.3 ± 1.1 d, respectively. The third-generation FEIA kit that we tested was highly reliable.

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“…Initial point-of-care P4 assays were semi-quantitative ( 10 ) and therefore considered less accurate than RIA ( 29 ). Subsequently, a fluorescence enzyme immunoassay point-of-care assay (AIA® 360, TOSOH Corp., Minato-ku, Tokyo, Japan) has demonstrated acceptable results when compared to RIA ( 11 ), liquid chromatography/tandem mass spectrometry ( 30 ) and CLIA ( 31 ).…”

Section: Discussionmentioning

confidence: 99%

Use of a Point-of-Care Progesterone Assay to Predict Onset of Parturition in the Bitch

et al. 2022

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An assay of circulating progesterone (P4) is commonly used to estimate progress through late gestation in the bitch. Point-of-care assays provide rapid results, a major advantage over laboratory-based assays. This study aims to compare P4 levels determined by the Catalyst® Progesterone point-of-care assay with those determined by chemiluminescent immunoassay (CLIA) and to identify the expected distribution of Catalyst P4 levels at time intervals 3 days prior to the onset of parturition in pregnant bitches. Twenty-eight pregnant bitches carrying two or more fetuses were admitted to a specialist veterinary reproduction hospital 53 days after the onset of cytological diestrus or, when that date was not known, 57 days after the last mating. Vaginal speculum examinations were performed every 6 h until the onset of cervical dilatation (TCD). Serum samples were collected twice daily (08h00 and 18h00) until TCD. For most samples, fresh serum was assayed for P4 immediately using the Catalyst assay (CatP4), then frozen until assayed by CLIA (IMMULITE 2000; ImmP4). However, for some samples, CatP4 was not analyzed prior to freezing. For these data points (n = 33), CatP4 for fresh serum was estimated from CatP4 assayed on frozen-thawed serum, based on a comparison between CatP4 on fresh vs. frozen-thawed sera. In comparison to ImmP4, CatP4 levels up to and including 7 nmol/L appear to have a constant bias of −1.69 nmol/L (limits of agreement −4.91 to 1.52), while levels >7 nmol/L appear to have a proportional bias of −17.9% (limits of agreement −68.6% to 32.7%). Bootstrapped percentiles of CatP4 results spanned 0.4–9 nmol/L within 12 h of TCD, 0.9–11 nmol/L 12–24 h from TCD, and 2.2–13.5 nmol/L 24–36 h from TCD. A CatP4 >9 nmol/L indicates a bitch that is unlikely to reach TCD within 12 h. Bitches with CatP4s below 3.5 nmol/L are likely to reach TCD within 36 h and bitches with a CatP4 below 2.2 nmol/L are likely to reach TCD within 24 h. In conclusion, the Catalyst Progesterone assay provides rapid assessment of circulating P4 in the bitch, with clinical application in the monitoring of late term pregnant bitches.

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Laboratory and Clinical Evaluation of a Feia Method for Canine Serum Progesterone Assay

Cited by 13 publications

References 32 publications

Comparison of a Point-of-Care Analyzer With a Chemiluminescent Immunoassay for Serum Progesterone Measurement in Breeding Management of the Bitch

Comparison of a Point-of-Care Analyzer With a Chemiluminescent Immunoassay for Serum Progesterone Measurement in Breeding Management of the Bitch

Analytical and clinical performance of a fluorescence enzyme immunoassay for progesterone and determination of ovulation day in bitches

Use of a Point-of-Care Progesterone Assay to Predict Onset of Parturition in the Bitch

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