NHS evaluation scores Clinitest hCG assay highly

A Siemens Healthcare Diagnostics product story

Edited by the Laboratorytalk editorial team Mar 30, 2007

With a sensitivity of 25IU/l human chorionic gonadotrophin (hCG), Clinitest hCG is designed to remove all subjectivity from the interpretation of pregnancy test reactions, delivering automated results

The sensitivity, accuracy and ease of use offered by the automated Clinitest hCG assay (from Siemens Medical Solutions Diagnostics), has been highlighted in an evaluation of eleven 'pallet-type' professional urine pregnancy tests conducted recently by the NHS Purchasing and Supply Agency (Pasa).

The evaluators found the test both simple and easy to use on Clinitek Status urine chemistry analyser at the point of care, singling out the system's automated assay timing, volumetric sample loading pipette and training support for particular praise.

With a sensitivity of 25IU/l human chorionic gonadotrophin (hCG), Clinitest hCG is designed to remove all subjectivity from the interpretation of pregnancy test reactions by delivering automated test results on the Clinitek Status.

The instrument monitors control and reference regions on each test cassette in order to verify the addition of sufficient sample volume and that proper flow has occurred.

Each test is also timed automatically by the analyser, eliminating the risk of operator error.

Patient and operator ID can easily be input into the Clinitek Status, and results can be printed out if required.

The system is fully connectable, allowing users to attain a clear audit trail and download results into patient records.

The evaluators found the system "simple and easy to use", adding that "all information is clearly presented" and "training was comprehensive and of good quality".

They also commented on the fact that results are only released after a full five minute incubation or once a positive line has been detected, preventing operator read timing errors.

Another comment was that "the volumetric bulb pipette was easy to use and ensured the addition of the correct sample volume".

Results obtained in the evaluation confirmed the claimed sensitivity of 25IU/l for the test cassette.

Clinitest hCG and Clinitek Status now form part of the extensive Siemens Medical Solutions Diagnostics product portfolio following the company's recent acquisition of Bayer Healthcare's diagnostics division.

Commenting on the results of the evaluation, Siemens Diagnostics point of care product manager Nicola Ralph said: "It is pleasing to see that our assay performed as anticipated and that our ease of use and training were praised, as these are key aspects in ensuring quality results and customer satisfaction.

"When used in conjunction with the Clinitek Status, the Clinitest hCG test cassettes go a long way toward removing the subjectivity of interpretation as they are unaffected by varying light conditions.

"They also eliminate the possibility of errors in operator sampling through use of a volumetric pipette, while additionally removing the risk of timing errors since the incubation period for the test is timed automatically by the Clinitek Status.

"The whole system is designed to ensure pregnancy tests are fully standardised, delivering clear unequivocal results that users can rely on every time - even when working under pressure.".