Analysis of diagnostic efficacy of TSPOT.TB, Genechip, AFB, and their combined applications in tuberculosis

doi:10.3877/cma.j.issn.1674-6902.2024.01.004

Abstract

Abstract:

Objective

The T cells spot test of tuberculosis infection(TSPOT.TB) and Genechip assays are new methods for the diagnosis and detection of tuberculosis (TB) infection. There is limited research on these methods in China. Since January 2021, the TSPOT.TB and Genechip assays have been routinely used at Tangdu Hospital. Therefore, the aim of this study was to investigate the efficacy of TSPOT.TB and Genechip assays and explore the feasibility of their combined diagnosis, providing reference and guidance for TB detection and diagnosis in non-TB comprehensive hospitals.

Methods

A retrospective study was conducted on 256 hospitalized patients admitted to Tangdu Hospital from January, 2021, to April, 2023. All patients underwent TSPOT.TB, Genechip, and acid-fast bacilli smear microscopy (AFB) tests. Active TB cases were considered based on a composite reference standard (CRS). The three diagnostic methods were compared and evaluated.

Results

A total of 256 patients underwent TSPOT.TB, Genechip, and AFB testing simultaneously. Among them, 105(41.02%) were diagnosed with active TB. with 141(55.08%) being over 60 years old and 105(44.92%) being under 60 years old. For patients over 60 years old, the sensitivity, specificity, and AUC of T-SPOT.TB, AFB, and Genechip assays for TB detection were as follows: 47.45%, 82.93%, 0.652; 16.94%, 98.78%, 0.579; 74.57%, 98.78%, 0.867. For patients under 60 years old, the sensitivity, specificity, and AUC of T-SPOT.TB, AFB, and Genechip assays for TB detection were as follows: 44.65%, 85.50%, 0.656; 10.86%, 100.00%, 0.554; 73.91%, 98.55%, 0.862. In combined testing, for patients over 60 years old, the AFB+ Genechip assay showed the highest diagnostic efficacy with sensitivity, specificity, and AUC of 84.74%, 97.56%, and 0.912, respectively. For patients under 60 years old, the T-SPOT.TB+ AFB+ Genechip combination had the highest diagnostic efficacy with sensitivity, specificity, and AUC of 100.00%, 84.05%, and 0.920, respectively.

Conclusion

The Genechip assay has high sensitivity and specificity and is highly valuable in TB diagnosis. However, the combined use of TSPOT.TB, AFB, and Genechip assays for TB diagnosis shows higher efficacy and can more effectively diagnose TB.

Key words: Tuberculosis, T cells spot test of tuberculosis infection, Genechip, Acid-fast bacilli smear microscopy

huanqing Xiong, huiqin Wang, yujuan Li, gang Liu, Faguang Jin. Analysis of diagnostic efficacy of TSPOT.TB, Genechip, AFB, and their combined applications in tuberculosis[J]. Chinese Journal of Lung Diseases(Electronic Edition), 2024, 17(01): 19-24.

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Figures/Tables 4

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指标检测	敏感性(%)(95%CI)	特异性(%)(95%CI)	阳性预测值(%)(95%CI)	阴性预测值(%)(95%CI)
TSPOT.TB	46.22(36.56～56.22)	82.67(75.63～88.47)	65.30(55.61～73.83)	68.52(64.24～72.46)
AFB	14.15(8.12～22.34)	99.33(96.35～100.00)	93.76(66.73～99.17)	62.03(60.21～63.95)
Genechip	75.47(66.26～83.34)	99.33(96.35～100.00)	98.70(91.83～99.81)	85.11(80.42～88.86)

指标检测	敏感性(%)(95%CI)	特异性(%)(95%CI)	阳性预测值(%)(95%CI)	阴性预测值(%)(95%CI)
TSPOT.TB	46.22(36.56～56.22)	82.67(75.63～88.47)	65.30(55.61～73.83)	68.52(64.24～72.46)
AFB	14.15(8.12～22.34)	99.33(96.35～100.00)	93.76(66.73～99.17)	62.03(60.21～63.95)
Genechip	75.47(66.26～83.34)	99.33(96.35～100.00)	98.70(91.83～99.81)	85.11(80.42～88.86)

指标单和/或叠加	灵敏度(%)(95%CI)	特异性(%)(95%CI)	阳性预测值(%)(95%CI)	阴性预测值(%)(95%CI)
TSPOT.TB	47.45(34.22～60.86)	82.93(73.01～90.33)	66.67(53.62～77.54)	68.60(62.85～74.01)
AFB	16.94(8.41～28.93)	98.78(93.31～99.90)	90.96(56.82～98.78)	62.33(59.51～65.07)
Genechip	74.57(61.51～85.03)	98.78(93.31～99.90)	97.76(86.14～99.68)	84.30(77.71～89.35)
TSPOT.TB＋AFB	52.54(39.10～65.76)	81.70(71.64～89.32)	67.31(55.10～77.63)	70.55(64.24～76.19)
AFB＋Genechip	84.74(73.02～92.76)	97.56(91.42～99.78)	96.15(86.30～98.91)	89.83(82.94～94.16)
TSPOT.TB＋Genechip	89.83(79.16～96.10)	82.92(73.01～90.33)	79.12(69.91～86.05)	91.88(84.03～96.04)
TSPOT.TB＋AFB Genechip	94.91(85.82～98.90)	81.71(71.63～89.31)	78.85(70.10～85.51)	95.76(88.04～98.51)

指标单和/或叠加	灵敏度(%)(95%CI)	特异性(%)(95%CI)	阳性预测值(%)(95%CI)	阴性预测值(%)(95%CI)
TSPOT.TB	47.45(34.22～60.86)	82.93(73.01～90.33)	66.67(53.62～77.54)	68.60(62.85～74.01)
AFB	16.94(8.41～28.93)	98.78(93.31～99.90)	90.96(56.82～98.78)	62.33(59.51～65.07)
Genechip	74.57(61.51～85.03)	98.78(93.31～99.90)	97.76(86.14～99.68)	84.30(77.71～89.35)
TSPOT.TB＋AFB	52.54(39.10～65.76)	81.70(71.64～89.32)	67.31(55.10～77.63)	70.55(64.24～76.19)
AFB＋Genechip	84.74(73.02～92.76)	97.56(91.42～99.78)	96.15(86.30～98.91)	89.83(82.94～94.16)
TSPOT.TB＋Genechip	89.83(79.16～96.10)	82.92(73.01～90.33)	79.12(69.91～86.05)	91.88(84.03～96.04)
TSPOT.TB＋AFB Genechip	94.91(85.82～98.90)	81.71(71.63～89.31)	78.85(70.10～85.51)	95.76(88.04～98.51)

指标单和/或叠加	敏感性(%)(95%CI)	特异性(%)(95%CI)	阳性预测值(%)(95%CI)	阴性预测值(%)(95%CI)
TSPOT.TB	44.65(31.14～60.82)	85.50 (75.71～92.53)	63.61(48.73～76.35)	72.30(66.54～77.41)
AFB	10.86(3.38～23.56)	100.00(95.41～100.00)	100.00(47.89～100.00)	65.53(58.02～75.01)
Genechip	73.91(57.56～84.54)	98.55(93.21～99.63)	94.46(81.02～98.58)	85.71(79.06～90.52)
TSPOT.TB＋AFB	50.00(34.91～65.03)	85.51(74.93～92.81)	69.62(54.76～81.34)	71.92(65.43～77.66)
AFB＋Genechip	84.78(71.14～93.66)	98.55(92.14～99.92)	97.56(84.73～99.61)	90.62(83.05～95.07)
TSPOT.TB＋Genechip	95.65(85.24～99.46)	84.05(73.21～91.73)	80.01(69.83～87.35)	96.67(88.12～99.18)
TSPOT.TB＋AFB＋Genechip	100.00(92.26～100.00)	84.05(73.24～91.70)	80.76(70.85～87.77)	100.00(93.84～100.00)

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