ANTI-D (RH1) TOTEM

Product reference 71010

Designation ANTI-D (RH1) TOTEM

Cell lines P3x61 + P3x21223B10

+ P3x290 + P3x35

CE marked CE marked product according to Directive 98/79/EC

Product appearance Colorless liquid

Destination ANTI-D (RH1) TOTEM is used for blood grouping. It

enables the determination of the presence of erythrocytic
antigen D on the human red blood cells surface

Packaging 5 x 10 ml – 1 000 tests

Vial of 10 ml, clear neutral glass
Gauged dropper, white cap, white nozzle

Description The reagents are prepared from monoclonal antibodies in

a storage medium. The monoclonal antibodies, IgM and
IgG type, produced by DIAGAST are derived from the
supernatants of in vitro cultures of hybridomas of human
origin

Technique of use 1) Plate technique at room temperature (18-25°C)

2) Tube technique at room temperature (18-25°C),
immediate centrifugation
3) Indirect Antiglobulin Test (IAT)

Performances Respect of the standard technical specifications:

● Positive reactions with any technique as regards
2 CcDee red blood cells, 2 ccDEe red blood cells and
2 weak D (only with IAT)
● Negative reactions with any technique as regards
1 Ccdee red blood cell, 1 ccdEe red blood cell and
1 ccdee red blood cell
The assessments demonstrated 100% specificity of each
reagent versus the expected results vis-à-vis common
Rhesus phenotypes known
 ANTI-D (RH1) TOTEM
Filtration This material has been filtered through a 0.2 µm filter

Storage temperature Store refrigerate at 2-8°C – Do not freeze

Minimum expiry guaranteed 9 months

Maximum expiry 15 months

Validity period after opening Product expiration

Reading time Immediate reading

Country of manufacture France

Tests for virus Source material from which this cell line was derived was
tested and found negative for HIV, HBs Ag and HCV

Sodium azide content < 0.1% w/v

Minimum titer guaranteed Red blood cells CcDee CcDee

(+/- one titer comparing to the DIAGAST Technique Tube IAT
standard)
Titer 32 64

Minimum titer observed*

(+/- one titer comparing to the DIAGAST
Red blood cells CcDee CcDee
standard) Technique Tube IAT
Titer 128 128
* Minimum titers observed on 10 batches validated before 2010/12/31

Safety data sheet According to the REACH regulation, this reagent is not
considered as a hazardous material (no pictogram), so
there isn’t need to provide safety data sheet

IFU available on www.diagast.com → Instructions for use

Key code DIA00103