An evaluation of near patient tests for detecting herpes simplex virus type-2 antibody.
OBJECTIVE
To examine the "in use" test characteristics of the POCkit "near patient" HSV-2 rapid test for the detection of HSV-2 IgG antibodies for use in the clinic. This test relies on a visual interpretation of the result.


METHODS
2093 serum samples, 229 from UK and 919 from Italian genitourinary medicine clinic patients and 945 from obstetric and gynaecology clinic patients in Italy were tested. Tests were carried out according to manufacturers' protocol in the United Kingdom and Italy. Three readers independently recorded a score for each test carried out and the results were compared.


RESULTS
In the UK study, the three readers disagreed on the result on 5.2% of tests. In the Italian study, there was disagreement in 10.2% of tests.


CONCLUSIONS
This study has demonstrated a problem in the subjective nature of the interpretation of the POCkit HSV-2 test. It highlights the need for adequate training of clinic staff and the need for clinics to adopt policies of quality assurance and ongoing monitoring which will ensure the validity and accuracy of this clinic based test.
Saville
M
M
Enteric and Respiratory Virus Laboratory, CPHL, London, UK.
Brown
D
D
Burgess
C
C
Perry
K
K
Barton
S
S
Cowan
F
F
Palu
G
G
Mengoli
C
C
D000914:Antibodies, Viral / Q000097:blood*; D006558:Herpes Genitalis / Q000175:diagnosis*; D018258:Herpesvirus 2, Human / Q000276:immunology*; D006801:Humans; D015588:Observer Variation; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results
D000914:Antibodies, Viral; D011933:Reagent Kits, Diagnostic