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The Binax NOW Streptococcus pneumoniae Test is an in vitro rapid immunochromatographic assay for the detection of Streptococcus pneumoniae (S. pneumoniae) antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. It is intended, in conjunction with culture and other methods, to aid in the presumptive diagnosis of both pneumococcal pneumonia and pneumococcal meningitis.

The Binax NOW Streptococcus pneumoniae Test is an immunochromatographic membrane assay used to detect pneumococcal soluble antigen in human urine and CSF. Rabbit anti-S. pneumoniae antibody, the Sample Line, is adsorbed onto nitrocellulose membrane. Control antibody is adsorbed onto the same membrane as a second stripe. Both rabbit anti-S. pneumoniae and anti-species antibodies are conjugated to visualizing particles that are dried onto an inert fibrous support. The resulting conjugate pad and striped membrane are combined to construct the test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a hinged, book-shaped test device (U.S. patent No. 2 U.S. 91/214051). To perform the test (2 U.S. patents pending), a swab is dipped into the specimen, removed, and then inserted into the test device. Reagent A, a buffer solution, is added from a dropper bottle. The device is then closed, bringing the sample into contact with the test strip. Pneumococcal antigen present in the sample reacts to bind anti-S. pneumoniae conjugate antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-S. pneumoniae antibody, forming the Sample Line. Immobilized control antibody captures anti-species conjugate, forming the Control Line. There are no transferring steps, the sample is contained, and results are available within 15 minutes.

The Trinity Biotech Uni-Gold™ Strep A test kit is intended for the rapid, in vitro qualitative detection of group A Streptococcal antigen from human throat swabs. It can also be used as a confirmation test of beta-haemolytic colonies obtained from blood agar plates. The test is intended for professional use in physicians offices as an aid in the rapid diagnosis of group A Streptococcal pharyngitis. The test may also be used in hospital laboratories as an aid in the rapid diagnosis of group A Streptococcal pharyngitis and the confirmation of group A Streptococcus from culture.

The extracted sample flows through an absorbent pad containing anti-Strep A antibody conjugated to colloidal gold which binds group A Streptoccal antigen if present, forming an antigen-antibody complex. As this complex travels along the membrane, it becomes immobilised at the test region, which is impregnated with a rabbit polyclonal anti-Strep A antibody, resulting in the formation of a pink/red line. A pink/red line will also appear in the control region of the test indicating proper functioning of the test. In the absence of group A Streptococcal antigen, a pink/red line will only appear in the control line.

The Binax NOW Streptococcus pneumoniae Urinary Antigen Test is a rapid immunochromatographic assay for the detection of S. pneumoniae antigen in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of pneumococcal pneumonia in conjunction with culture and other methods.

The Binax Now Streptococcus pneumoniae Antigen Test is a urinary immunochromatographic membrane assay used to detect Streptococcus pneumoniae (S. pneumoniae) antigen in human urine. A test strip, containing gold-conjugated and immobilized anti-S. pneumoniae antibodies, and a swab well are mounted on opposite sides of a cardboard, book-shaped hinged test device. A swab is dipped into the urine to be tested and then inserted into the swab well. A single reagent is added to the swab well from a dropper bottle before closing the test device. Pneumococcal antigen present in the urine sample reacts to bind anti-S. pneumoniae antibody conjugated to gold. The resulting antigen-conjugate complexes are captured by immobilized anti-S. pneumoniae antibody, forming the Sample Line. Immobilized goat anti-rabbit IgG captures excess visualizing conjugate, forming the Control Line.

Abbott TestPack Plus Strep A with On Board Controls (OBC) II is a rapid immunoassay for the qualitative detection of Group A Streptococcal (Group A Strep) antigen in throat swab specimens from patients with suspected Group A Strep associated pharyngitis and for confirmation of presumptive Group A Strep colonies isolated on culture plates.

TestPack Plus Strep A with OBC II is a rapid immunoassay for the qualitative detection of Group A Streptococcal antigen from throat swab specimens or confirmation of presumptive Group A Strep colonies recovered from culture. TestPack Plus Strep A with OBC II utilizes an internal on board control system consisting of six control features.

The BioStar® STREP A OIA® MAX assay is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs. This test is intended for in vitro diagnostic use to rapidly identify Group A Streptococci in throat swab specimens from patients with suspected Group A streptococci-associated pharyngitis as an aid in the diagnosis of streptococcal infection.

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STREPTOLEX-STAT™ is substantially equivalent to several commercially available products utilizing similar methodology for the identification of streptococcal groups A, B, C, F and G.

OSOM™ Strep A Test is an immunochromatographic assay for the qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies from culture.

OSOM Strep A Test uses color immunochromatographic dip stick technology with antibodies coated on the membrane. If group A Streptococcus is present in the swab sample, a blue test line will appear to indicate a positive result.

qualitative detection of group A strep antigen from throat swabs

solid phase migratory chromatography immunoassay in vitro diagnostic test kit

The CARDS Q.S. Strep A/Concise Performance Plus Strep A is a sensitive immunoassay for the qualitative detection of group A streptococcal antigen from throat swab specimens. This test is to be used to aid in the diagnosis of diseases caused by group A Streptococcus. The test is for use by health care professionals.

The device, CARDS Q.S. Strep A (also sold under the brand name Concise Performance Plus Strep A), is similar to other FDA-cleared devices used for the qualitative detection of group A streptococcal antigen from throat swab specimens, thereby aiding in the diagnosis of diseases caused by group A Streptococcus. To perform the test, a throat swab specimen is collected. Antigen is extracted from the swab specimen with Reagents A and B. The extracted sample is added to the Reaction Unit. If the sample contains strep A antigen, a pink vertical line forms in the Read Result Window. This pink vertical line, together with the pre-printed blue horizontal line, form a plus sign (+) to indicate a positive result. If strep A antigen is not present in the sample, the Read Result Window shows only the pre-printed blue horizontal line, forming a minus sign (-) to indicate a negative result. As the sample continues to move through the test, the procedural Control Window containing strep A antigen becomes pink. Pink color in the Control Window confirms that the test is functionally active and has been performed correctly. The appearance of blue color in the Test Complete Window indicates the completion of the test. This occurs within approximately 5 minutes of adding the extracted sample to the Reaction Unit.