Intended Use
S. pneumoniae/L. pneumophila Combo Antigen Rapid Test Kit (Immunochromatographic Assay) is an in vitro, rapid, lateral flow test, also known as a lateral flow immunochromatographic assay, intended for the qualitative detection of Streptococcus pneumoniae and Legionella pneumophila antigens in urine specimens from patients with symptoms of pneumonia. The assay is intended to aid in diagnosis of S. pneumonia and L. pneumophila serogroup 1 infections. Results from S. pneumoniae/L. pneumophila Combo Antigen Rapid Test Kit should be interpreted in conjunction with the patient’s clinical evaluation and other diagnostic methods.
Test Principle
S. pneumoniae/L. pneumophila Combo Antigen Rapid Test Kit (Immunochromatographic Assay) is a lateral flow chromatographic immunoassay. It has three pre-coatedlines, “T1” S. pneumoniae Test line, “T2” L. pneumophila Test line and “C” Control line on the nitrocellulose membrane. Mouse monoclonal anti-S. pneumoniae and anti-L. pneumophila antibodies are coated on the test line region and Goat anti-chicken IgY antibodies are coated on the control region.
Materials / provided | Quantity(1 Test/Kit) | Quantity(5 Tests/Kit) | Quantity(25 Tests/Kit) |
Test Kit | 1 test | 5 tests | 25 tests |
Buffer | 1 bottle | 5 bottles | 25/2 bottles |
Dropper | 1 piece | 5 pcs | 25 pcs |
Specimen Transport Bag | 1 piece | 5 pcs | 25 pcs |
Instructions For Use | 1 piece | 1 piece | 1 piece |
Certificate of Conformity | 1 piece | 1 piece | 1 piece |
Please read the instructions carefully before testing. Before testing, allow the test cassettes, sample solution and samples to be balanced to room temperature (15-30℃ or 59-86 degrees Fahrenheit).
1. Take out the cassette, put it on a horizontal table.
2. Using the disposable dropper supplied, collect sample and add 3 drops (125 μL) of urine and 2 drops (90 μL) of buffer to the round sample well on the test cassette. Start counting. (The test Cassette should not be handled or moved until the test is complete and ready for reading.)
3. Read the result in 10-15 minutes. The result explanation time should not more than 20 minutes.
1. S. pneumoniae Positive
Colored bands appear at both test line (T1) and control line (C). It indicates positive result for the S. pneumoniae antigens in the specimen.
2. L. pneumophila Positive
Colored bands appear at both test line (T2) and control line (C). It indicates positive result for the L. pneumophila antigens in the specimen.
3. S. pneumoniae and L. pneumophila Positive
Colored bands appear at both test line (T1), test line (T2) and control line (C). It indicates positive result for the S. pneumoniae and L. pneumophila antigens in the specimen.
4. Negative Result
Colored band appear at control line (C) only. It indicates that the concentration of S. Pneumoniae or L. pneumophila antigens do not exist or below the detection limit of the test.
5. Invalid Result
No visible colored band appears at control line after performing the test. The directions may not have been followed correctly or the test may have deteriorated. It is recommended that the specimen be re-tested.
Product Name | Cat. No | Size | Specimen | Shelf Life | Trans. & Sto. Temp. |
S. pneumoniae/L. pneumophila Combo Antigen Rapid Test Kit(Immunochromatographic Assay) |
B027C-01 | 1test/kit | Urine | 18 Months | 2-30℃ / 36-86℉ |
B027C-05 | 5 tests/kit | ||||
B027C-25 | 25 tests/kit |