Name: Rubella IgG/IgM
Brand: Reckon Diagnostics
SKU: RDT-RBL.117

Cassette: no photograph of this pack is published yet

Drawing, not a photograph. This pack has not been photographed yet; the stock codes and pack sizes below are the specification.

Supplied as 25 tests.

Pack size

25 TestRDT-RBL.117

Stock code RDT-RBL.117

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Made and batch-released in Vadodara
ISO 13485:2016 quality system
Datasheet published: see every stock code below

Product details.

The Rubella IgG/IgM card is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to rubella virus in human serum or plasma, as an aid in diagnosis. Rubella recombinant envelope antigens on colloidal gold feed separate IgM and IgG test lines. Manufactured at Reckon’s Vadodara facility under ISO 13485:2016 quality management, and released against reference standards before dispatch.

The specifications and steps on this page are from the datasheet, last updated 10-2020. The datasheet governs: read it before use, or ask us.

Method: Chromatographic immunoassay
Sample: Serum or plasma
Sample volume: 1 drop (about 10 µl)
Read at: 15 minutes
Storage: 2 to 40 °C
Pack: 25 tests

Full specification13 items

Category: Rapid diagnostics
Pack: 25 tests
Datasheet: Published
Method: Chromatographic immunoassay, colloidal gold
Detects: IgM (line M) and IgG (line G) antibodies to rubella virus
Sample: Serum or plasma, clear and non-hemolysed; 7 days at 2 to 8 °C, frozen at −20 °C beyond that; not grossly lipemic or turbid
Sample volume: 1 drop (about 10 µl)
Buffer: 2 drops (about 70 µl); 1 more if the membrane has not wetted after 1 minute
Read at: 15 minutes; not after 20 minutes
Limitation: Qualitative only, and line intensity does not track antibody concentration
Storage: 2 to 40 °C in the sealed pouch; use within 1 hour of opening
Stock codes: RDT-RBL.117
Made in: Vadodara, Gujarat, India

Performance5 figures

Sensitivity: IgM 96.8%, IgG 97.4% (relative, clinical comparison)
Specificity: IgM 98.0%, IgG 98.5% (relative)
Agreement: IgM 97.6%, IgG 98.1% overall
Cross-reactivity: None with specimens from patients with HIV, HAV, HTLV, HCV or TP, nor from albumin, bilirubin, hemoglobin, glucose, uric acid or lipids at high concentrations
Interference: None from 17 common analytes, including acetaminophen, ampicillin, ascorbic acid and caffeine at 200 µg/ml, EDTA at 800 µg/ml, ethanol at 1% and methanol at 10%

Procedure at a glance5 steps

Let the device and the specimen reach 15 to 30 °C, and open the pouch only when ready.
Lay the cassette on a clean, level surface.
Add 1 drop (about 10 µl) of serum or plasma to specimen well S, then 2 drops (about 70 µl) of buffer, and start the timer.
Read at 15 minutes; do not interpret after 20 minutes.
C only is negative; C and M is IgM positive (primary infection); C and G is IgG positive (recent or repeat infection); C, M and G is positive for both; no C line means the test is invalid.