Table 4.
Antibody testing methods and CCP component modification
| Country, Institution | Component antibody testing? | Anti‐SARS‐CoV‐2 antibodies testing methods | Pathogen inactivation? | |
|---|---|---|---|---|
| Method | Cut‐off criteria to qualify donor/donation | |||
| Americas | ||||
| Argentina | No a | ELISA (COVIDAR) | >800 | No |
| Brazil | Yes |
VNT ELISA |
≥1:160NA | INTERCEPT® |
| Canada, Héma‐Québec | Yes | ELISA b | >cut‐off at 1:100 plasma dilution | No |
| Canada, CBS | Yes | VNT | PRNT50 titre of ≥1:160 | No |
| United States, Vitalant | No a | ELISA (Euroimmun) | >cut‐off at 1:100 plasma dilution | No |
| United States, ARC | Yes | CLIA (VITROS) | S/C ≥ 1·0 | No |
| United States, OneBlood | Yes |
CLIA (VITROS) (screening) CLIA (Elecsys) (confirmatory) |
S/C ≥ 10 | No |
| Africa | ||||
| South Africa, SANBS | Yes | ELISA c | OD ≥ 1·0 (transfusion)No cut‐off (fractionation) | INTERCEPT® |
| South Africa, UCT | Yes | VNT | ≥1:160 (transfusion) | Mirasol® |
| Eastern Mediterranean Region | ||||
| Egypt | Yes |
Rapid Test (AMEDA) CLIA (MAGLUMI) CLIA (Elecsys) |
Reactive ≥ 1·0 AU/ml (transfusion) ≥10·0 AU/ml (fractionation) S/C ≥1 (transfusion) S/C ≥10 (fractionation) |
Lipid enveloped virus inactivation by Caprylic Acid for immunoglobulin production |
| Israel | Yes |
Rapid Test (PharmaAct) CMIA (Architect) |
Reactive S/C > 4 (transfusion) S/C > 1·4 (fractionation) |
No |
| Oman | Yes | ELISA (EUROIMMUN) | OD ≥ 2 | Mirasol® |
| Saudi Arabia | No a | VNT | 1:80 | INTERCEPT® |
| Europe | ||||
| Belgium | No a | VNT | >1:320 | Methylene blue |
| Finland | Yes | VNT | None | No |
| France | Yes | ELISA (EUROIMMUN) VNT d | OD ≥ 8≥ 1:80 | INTERCEPT® |
| Germany | No a | VNT | >1:20 | No |
| Italy | Yes | VNT | ≥1:160 | Yes (type not specified) |
| Norway | Yes e | Anti‐SARS‐CoV‐2 commercial tests, In‐house multiplex tests, VNT | Not established | No |
| The Netherlands | Yes | ELISA | OD ≥ 0·1 | No |
| Turkey, BUU | No a | CMIA (Architect) | S/C > 1·4 | No |
| Turkey, TRC | Yes | ELISA (EUROIMMUN) CLIA (Elecsys) | Undisclosed | Mirasol® |
| Turkey, AHGH | No a | Rapid test | Reactive | INTERCEPT® |
| United Kingdom | Yes | ELISA (EUROIMMUN) | OD ≥ 6 | No |
| South‐East Asia | ||||
| India, AIIMS | No a | CMIA (Architect) | S/C ≥ 1·4 | No |
| India, PGIMER | No a | CLIA (VITROS) | S/C ≥ 13·0 | No |
| Indonesia | No a | Rapid test (Assure Fastep) | ≥1:80 | No |
| Western Pacific | ||||
| Australia | Yes f |
CMIA (Architect) (screening) ELISA (EUROIMMUN) (screening) VNT |
S/C ≥ 1·4 OD ≥ 1 ≥1:80 (transfusion) ≥1:40 (fractionation) |
No |
| China, BRCBC, WHBC, SXBC | Yes | ELISA (IgG) ELISA (Total) | IgG ≥ 1:160 Total ≥ 1:320 | Variable Methylene blue |
| Hong Kong, China | Yes | VNT | >1:80 | No |
| Singapore, HAS, TTSH | No a | VNT | >1: 80 (Apheresis); >1:40 (WB) | No |
| South Korea | Yes | Rapid test (AFIAS) | COI > 1·0 | No |
AHGH, Acıbadem Health Group Hospitals; AIIMS, All India Institute of Medical Sciences; ARC, American Red Cross; AU, absorbance unit/ml; BRCBC, Beijing Red Cross Blood Center; BUU, Bursa Uludağ University; CBS, Canadian Blood Services; CLIA, chemiluminescence enzyme immunoassay; CMIA, Chemiluminescent microparticle immunoassay; ELISA, enzyme‐linked immunosorbent assay; HAS, Health Sciences Authority, NA, not applicable; OD, optical density ratio; PGIMER, Post Graduate Institute of Medical Education and Research; SANBS, South African National Blood Service; SARS‐CoV‐2, severe acute respiratory syndrome coronavirus‐2; S/C, signal to cut‐off index; SXBC, Shaanxi Blood Center; TRC, Turkish Red Crescent; TTSH, Tan Tock Seng Hospital; UCT, University of Cape Town; VNT, virus neutralization test; WB, whole blood; WHBC, Wuhan Blood Center.
Testing is done on the donor sample.
Anti‐SARS CoV‐2 antibodies against total spike protein, neutralization assay, antibody‐dependent cell‐mediated cytotoxicity assay are done at external collaborators’ laboratories.
Initially, samples with sufficiently high OD on ELISA test were tested for neutralizing antibodies, however the later was discontinued.
Neutralizing antibody test is done for CCP units with OD ratio≥ 1·6 (earlier 1·1) and < 8 (earlier 5·6) on Euroimmun anti‐SARS‐CoV‐2 ELISA assay.
For transfusion, the donation must be positive on one of the two screening tests and have a neutralizing antibody titre ≥1:80.
For release for clinical use, the donation must be positive on one of the two screening tests and have a neutralizing antibody titre >1:80.